ABOUT US

PRODUCTS

BLOGS

ABOUT US

PRODUCTS

BLOGS

ABOUT US

PRODUCTS

BLOGS

Active Pharmaceutical Ingredient

High-purity raw ingredients for pharmaceutical manufacturing.

Omeprazole

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Korea DMF

Abiraterone Acetate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF, Russia DMF

Acalabrutinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Adagrasib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Amlodipine Besylate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Apalutamide (Amorphous & Form B)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Brazil DMF, USDMF

Apixaban

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, Korea DMF, China DMF

Apremilast (Amorphous & Form B)

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF

Atomoxetine Hydrochloride

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Canada DMF

Atorvastatin Calcium (Amorphous And Form 1)

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Russia DMF, China DMF

Azacitidine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Powder

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Bempedoic Acid

Therapeutic Category:

Cardiovascular

Dose Form:

Cardiovascular

Regulatory Filing:

Brazil DMF

Bendamustine Hydrochloride

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF

Benztropine Mesylate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets, Injectable

Regulatory Filing:

USDMF

Bortezomib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Russia DMF

Cabazitaxel

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Russia DMF

Cabozantinib HCl

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Cabozantinib S-Malate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, Korea DMF

Capecitabine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Russia DMF, Korea DMF, China DMF

Carfilzomib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF, China DMF

Cetirizine Dihydrochloride

Therapeutic Category:

Respiratory

Dose Form:

Oral Solids, Liquid, Opthalmic

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Korea DMF, Russia DMF

Cinacalcet Hydrochloride

Therapeutic Category:

Endocrinology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Russia DMF, Brazil DMF, China DMF

Ciprofloxacin Hydrochloride

Therapeutic Category:

Anti-Infective

Dose Form:

Oral Solids

Regulatory Filing:

Clopidogrel Bisulfate (Form 1)

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Russia DMF, China DMF

Clopidogrel Bisulfate (Form 2)

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Russia DMF, China DMF

Dabigatran Etexilate Mesylate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, China DMF, CEP Submitted, Russia DMF

Dapagliflozin (Amorphous)

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solids

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, Russia DMF

Dapagliflozin (PG Solvate Monohydrate)

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, Russia DMF, China DMF

Darolutamide

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Dasatinib (Monohydrate)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, Taiwan DMF

Decitabine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, Korea DMF

Desloratadine

Therapeutic Category:

Respiratory

Dose Form:

Syrup, Reditab

Regulatory Filing:

USDMF, CEP Submitted, EUDMF

Deucravacitinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Dimethyl Fumarate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, EUDMF, Brazil DMF, China DMF

Donepezil HCl

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, EUDMF, Korea DMF

Doxazosin Mesylate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF

Dutasteride

Therapeutic Category:

Urology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF

Edaravone

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF

Elagolix Sodium

Therapeutic Category:

Pain Management

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF

Elinzanetant

Therapeutic Category:

Women's Health

Dose Form:

Tablets

Regulatory Filing:

Empagliflozin

Therapeutic Category:

Others

Dose Form:

Liquid

Regulatory Filing:

USA, Europe, Korea DMF, Canada DMF

Enzalutamide

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Soft Gel Capsule

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, China DMF

Eribulin

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Canada DMF

Eslicarbazepine Acetate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, EUDMF

Esomeprazole Magnesium Trihydrate

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules, Suspension

Regulatory Filing:

USDMF, CEP Submitted, EUDMF, Canada DMF, China DMF, Brazil DMF

Eszopiclone

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF

Ezetimibe

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solids

Regulatory Filing:

USDMF, Brazil DMF

Famotidine

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solids

Regulatory Filing:

USDMF, CEP Submitted

Ferric Carboxymaltose

Therapeutic Category:

Nephrology

Dose Form:

Injectable

Regulatory Filing:

USDMF, China DMF, Malaysia DMF, Saudi Arabia

Fexofenadine Hydrochloride (Form 1)

Therapeutic Category:

Respiratory

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Japan DMF, Korea DMF

Fezolinetant

Therapeutic Category:

Gyneacology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Finasteride (Form 1)

Therapeutic Category:

Urology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Finasteride (Form III)

Therapeutic Category:

Urology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF

Fondaparinux Sodium

Therapeutic Category:

Cardiovascular

Dose Form:

Injectable

Regulatory Filing:

USDMF, Canada DMF, EUDMF, China DMF

Fosaprepitant

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF

Fruquintinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Gatifloxacin (Anhydrous)

Therapeutic Category:

Anti-Infective

Dose Form:

Opthalmic

Regulatory Filing:

Brazil DMF, USDMF

Gemcitabine Hydrochloride

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF, CEP Submitted, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Glimepiride

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted

Granisteron

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Subcutaeous Injection

Regulatory Filing:

USDMF, EUDMF, Korea DMF

Iron Sucrose

Therapeutic Category:

Nephrology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF

Ketorolac Tromethamine

Therapeutic Category:

Pain Management

Dose Form:

Dose Form Nasal

Regulatory Filing:

China DMF, USDMF, CEP Submitted, Brazil DMF, Korea DMF, Russia DMF

Lacidipine

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solids

Regulatory Filing:

EUDMF

Lenalidomide (Form A)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Russia DMF, Brazil DMF, USDMF, EUDMF, Canada DMF, China DMF, Japan DMF

Lenvatinib Mesylate ( MIBK Solvate)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, Korea DMF

Lenvatinib Mesylate (Form-C)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, Korea DMF

Levetiracetam

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Hard Gelatin Capsule/Tablet for Suspension

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, China DMF

Levocetirizine Dihydrochloride

Therapeutic Category:

Respiratory

Dose Form:

Solution/Tablet

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF, CEP Submitted

Levofloxacin Hemihydrate

Therapeutic Category:

Anti-Infective

Dose Form:

Injection/Solution/Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Korea DMF, Russia DMF

Lifitegrast

Therapeutic Category:

Opthamology

Dose Form:

Opthalmic

Regulatory Filing:

USDMF

Linagliptin

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF

Liraglutide

Therapeutic Category:

Anti-Diabetic

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Brazil DMF

Lomustine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, CEP Submitted, Russia DMF, China DMF

Losartan Potassium

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Japan DMF, Russia DMF

Lubiprostone

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Lumateperone Tosylate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF

Lurasidone Hydrochloride

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, China DMF

Mavacamten

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Memantine Hydrochloride

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules, Solution/Tablet

Regulatory Filing:

USDMF, Canada DMF, Russia DMF, China DMF

Metoprolol Succinate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, China DMF

Midostaurin

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Soft Gel Capsule, Oral Solids

Regulatory Filing:

USDMF, Brazil DMF

Mirabegron (Alpha)

Therapeutic Category:

Urology

Dose Form:

ER Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, China DMF, CEP Submitted

Montelukast Sodium

Therapeutic Category:

Respiratory

Dose Form:

Granular, Tablet or Chewable

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, China DMF, Japan DMF

Moxifloxacin Hydrochloride (Anhydrous)

Therapeutic Category:

Anti-Infective

Dose Form:

Oral Solids, Injectable, Opthalmic

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Korea DMF, Russia DMF, Egypt DMF

Naproxen

Therapeutic Category:

Pain Management

Dose Form:

Suspension/Oral Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Naproxen Sodium

Therapeutic Category:

Pain Management

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Korea DMF, Russia DMF

Naratriptan Hydrochloride

Therapeutic Category:

Pain Management

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF

Nilotinib Hydrochloride Monohydrate (Form B)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Korea DMF, China DMF

Niraparib Tosylate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Nizatidine

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Available Regulatory Filing USDMF, CEP Submitted, Japan DMF, Korea DMF

Olaparib (Form A)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Capsule/ Tablet

Regulatory Filing:

China DMF, USDMF, Brazil DMF

Omeprazole Magnesium

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, EUDMF

Ondansetron Base

Therapeutic Category:

Oncology/ Anti-Emetics

Dose Form:

Injection/Solution/Tablet

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF

Ondansetron Hydrochloride

Therapeutic Category:

Oncology/ Anti-Emetics

Dose Form:

Injection/Solution/Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, China DMF

Palbociclib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Capsule/ Tablet, Oral Solids

Regulatory Filing:

Brazil DMF, USDMF, Singapore DMF

Palonosetron Hydrochloride

Therapeutic Category:

Oncology/ Anti-Emetics

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Korea DMF

Pantoprazole Sodium

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Suspension/Oral Tablet, Injectable

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, China DMF

Pazopanib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Taiwan DMF

Pemetrexed Disodium Heptahydrate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Powder

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Perfluorohexyloctane

Therapeutic Category:

Opthamology

Dose Form:

Ophthalmic Solution

Regulatory Filing:

Permethrin

Therapeutic Category:

Anti-Infective

Dose Form:

Lotion (Topical)

Regulatory Filing:

USDMF, CEP Submitted, EUDMF, Korea DMF

Pioglitazone Hydrochloride

Therapeutic Category:

Anti-Diabetic

Dose Form:

Dose Form Oral Solid/Tablets

Regulatory Filing:

Brazil DMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, China DMF

Pirtobrutinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Pomalidomide

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Posaconazole

Therapeutic Category:

Anti-Infective

Dose Form:

Suspension/Oral Tablet, Delayed released tablets and solution

Regulatory Filing:

USDMF

Pregabalin

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Capsule/ Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Quetiapine Fumarate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Korea DMF, China DMF, Japan DMF

Rabeprazole Sodium (Amorphous & Form Y)

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Capsule/ Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Russia DMF, China DMF

Raloxifene Hydrochloride

Therapeutic Category:

Musculoskeletal

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Canada DMF, Korea DMF, China DMF

Ramipril

Therapeutic Category:

Cardiovascular

Dose Form:

Capsule/ Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Russia DMF, China DMF

Relugolix

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets, Injectable

Regulatory Filing:

USDMF, Brazil DMF

Resmetirom

Therapeutic Category:

Non-alcoholic Steatohepatitis

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Rimegepant

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

INFO

ABOUT US

BLOGS

PRODUCTS

FINISHED DOSAGE FORMULATIONS

ACTIVE PHARMACEUTICAL INGREDIENT

+91-22- 49737514

+91 9167218229

rajeev@aetherionpharma.com

shashank@aetherionpharma.com

ADDRESS

Suite#150, Adarsh Industrial Estate, Sahar International Airport Road, Chakala, Andheri East, Mumbai-400 099, Maharashtra, India

Beeyond Tech

INFO

ABOUT US

BLOGS

PRODUCTS

FINISHED DOSAGE FORMULATIONS

ACTIVE PHARMACEUTICAL INGREDIENT

+91-22- 49737514

+91 9167218229

rajeev@aetherionpharma.com

shashank@aetherionpharma.com

ADDRESS

Suite#150, Adarsh Industrial Estate, Sahar International Airport Road, Chakala, Andheri East, Mumbai-400 099, Maharashtra, India

Beeyond Tech

INFO

ABOUT US

BLOGS

PRODUCTS

FINISHED DOSAGE FORMULATIONS

ACTIVE PHARMACEUTICAL INGREDIENT

+91-22- 49737514

+91 9167218229

rajeev@aetherionpharma.com

shashank@aetherionpharma.com

ADDRESS

Suite#150, Adarsh Industrial Estate, Sahar International Airport Road, Chakala, Andheri East, Mumbai-400 099, Maharashtra, India

Beeyond Tech

INFO

ABOUT US

BLOGS

PRODUCTS

FINISHED DOSAGE FORMULATIONS

ACTIVE PHARMACEUTICAL INGREDIENT

+91-22- 49737514

+91 9167218229

rajeev@aetherionpharma.com

shashank@aetherionpharma.com

ADDRESS

Suite#150, Adarsh Industrial Estate, Sahar International Airport Road, Chakala, Andheri East, Mumbai-400 099, Maharashtra, India

Beeyond Tech

Active Pharmaceutical Ingredient

High-purity raw ingredients for pharmaceutical manufacturing.

Rimegepant

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Resmetirom

Therapeutic Category:

Non-alcoholic Steatohepatitis

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Relugolix

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets, Injectable

Regulatory Filing:

USDMF, Brazil DMF

Ramipril

Therapeutic Category:

Cardiovascular

Dose Form:

Capsule/ Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Russia DMF, China DMF

Raloxifene Hydrochloride

Therapeutic Category:

Musculoskeletal

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Canada DMF, Korea DMF, China DMF

Rabeprazole Sodium (Amorphous & Form Y)

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Capsule/ Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Russia DMF, China DMF

Quetiapine Fumarate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Korea DMF, China DMF, Japan DMF

Pregabalin

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Capsule/ Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Posaconazole

Therapeutic Category:

Anti-Infective

Dose Form:

Suspension/Oral Tablet, Delayed released tablets and solution

Regulatory Filing:

USDMF

Pomalidomide

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Pirtobrutinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Pioglitazone Hydrochloride

Therapeutic Category:

Anti-Diabetic

Dose Form:

Dose Form Oral Solid/Tablets

Regulatory Filing:

Brazil DMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, China DMF

Permethrin

Therapeutic Category:

Anti-Infective

Dose Form:

Lotion (Topical)

Regulatory Filing:

USDMF, CEP Submitted, EUDMF, Korea DMF

Perfluorohexyloctane

Therapeutic Category:

Opthamology

Dose Form:

Ophthalmic Solution

Regulatory Filing:

Pemetrexed Disodium Heptahydrate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Powder

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Pazopanib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Taiwan DMF

Pantoprazole Sodium

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Suspension/Oral Tablet, Injectable

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, China DMF

Palonosetron Hydrochloride

Therapeutic Category:

Oncology/ Anti-Emetics

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Korea DMF

Palbociclib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Capsule/ Tablet, Oral Solids

Regulatory Filing:

Brazil DMF, USDMF, Singapore DMF

Ondansetron Hydrochloride

Therapeutic Category:

Oncology/ Anti-Emetics

Dose Form:

Injection/Solution/Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, China DMF

Ondansetron Base

Therapeutic Category:

Oncology/ Anti-Emetics

Dose Form:

Injection/Solution/Tablet

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF

Omeprazole Magnesium

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, EUDMF

Omeprazole

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Korea DMF

Olaparib (Form A)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Capsule/ Tablet

Regulatory Filing:

China DMF, USDMF, Brazil DMF

Nizatidine

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Available Regulatory Filing USDMF, CEP Submitted, Japan DMF, Korea DMF

Niraparib Tosylate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Nilotinib Hydrochloride Monohydrate (Form B)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Korea DMF, China DMF

Naratriptan Hydrochloride

Therapeutic Category:

Pain Management

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF

Naproxen Sodium

Therapeutic Category:

Pain Management

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Korea DMF, Russia DMF

Naproxen

Therapeutic Category:

Pain Management

Dose Form:

Suspension/Oral Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Moxifloxacin Hydrochloride (Anhydrous)

Therapeutic Category:

Anti-Infective

Dose Form:

Oral Solids, Injectable, Opthalmic

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Korea DMF, Russia DMF, Egypt DMF

Montelukast Sodium

Therapeutic Category:

Respiratory

Dose Form:

Granular, Tablet or Chewable

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, China DMF, Japan DMF

Mirabegron (Alpha)

Therapeutic Category:

Urology

Dose Form:

ER Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, China DMF, CEP Submitted

Midostaurin

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Soft Gel Capsule, Oral Solids

Regulatory Filing:

USDMF, Brazil DMF

Metoprolol Succinate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, China DMF

Memantine Hydrochloride

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules, Solution/Tablet

Regulatory Filing:

USDMF, Canada DMF, Russia DMF, China DMF

Mavacamten

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Lurasidone Hydrochloride

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, China DMF

Lumateperone Tosylate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF

Lubiprostone

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Losartan Potassium

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Japan DMF, Russia DMF

Lomustine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, CEP Submitted, Russia DMF, China DMF

Liraglutide

Therapeutic Category:

Anti-Diabetic

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Brazil DMF

Linagliptin

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF

Lifitegrast

Therapeutic Category:

Opthamology

Dose Form:

Opthalmic

Regulatory Filing:

USDMF

Levofloxacin Hemihydrate

Therapeutic Category:

Anti-Infective

Dose Form:

Injection/Solution/Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Korea DMF, Russia DMF

Levocetirizine Dihydrochloride

Therapeutic Category:

Respiratory

Dose Form:

Solution/Tablet

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF, CEP Submitted

Levetiracetam

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Hard Gelatin Capsule/Tablet for Suspension

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, China DMF

Lenvatinib Mesylate (Form-C)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, Korea DMF

Lenvatinib Mesylate ( MIBK Solvate)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, Korea DMF

Lenalidomide (Form A)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Russia DMF, Brazil DMF, USDMF, EUDMF, Canada DMF, China DMF, Japan DMF

Lacidipine

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solids

Regulatory Filing:

EUDMF

Ketorolac Tromethamine

Therapeutic Category:

Pain Management

Dose Form:

Dose Form Nasal

Regulatory Filing:

China DMF, USDMF, CEP Submitted, Brazil DMF, Korea DMF, Russia DMF

Iron Sucrose

Therapeutic Category:

Nephrology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF

Granisteron

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Subcutaeous Injection

Regulatory Filing:

USDMF, EUDMF, Korea DMF

Glimepiride

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted

Gemcitabine Hydrochloride

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF, CEP Submitted, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Gatifloxacin (Anhydrous)

Therapeutic Category:

Anti-Infective

Dose Form:

Opthalmic

Regulatory Filing:

Brazil DMF, USDMF

Fruquintinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Fosaprepitant

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF

Fondaparinux Sodium

Therapeutic Category:

Cardiovascular

Dose Form:

Injectable

Regulatory Filing:

USDMF, Canada DMF, EUDMF, China DMF

Finasteride (Form III)

Therapeutic Category:

Urology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF

Finasteride (Form 1)

Therapeutic Category:

Urology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Fezolinetant

Therapeutic Category:

Gyneacology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Fexofenadine Hydrochloride (Form 1)

Therapeutic Category:

Respiratory

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Japan DMF, Korea DMF

Ferric Carboxymaltose

Therapeutic Category:

Nephrology

Dose Form:

Injectable

Regulatory Filing:

USDMF, China DMF, Malaysia DMF, Saudi Arabia

Famotidine

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solids

Regulatory Filing:

USDMF, CEP Submitted

Ezetimibe

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solids

Regulatory Filing:

USDMF, Brazil DMF

Eszopiclone

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF

Esomeprazole Magnesium Trihydrate

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules, Suspension

Regulatory Filing:

USDMF, CEP Submitted, EUDMF, Canada DMF, China DMF, Brazil DMF

Eslicarbazepine Acetate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, EUDMF

Eribulin

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Canada DMF

Enzalutamide

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Soft Gel Capsule

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, China DMF

Empagliflozin

Therapeutic Category:

Others

Dose Form:

Liquid

Regulatory Filing:

USA, Europe, Korea DMF, Canada DMF

Elinzanetant

Therapeutic Category:

Women's Health

Dose Form:

Tablets

Regulatory Filing:

Elagolix Sodium

Therapeutic Category:

Pain Management

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF

Edaravone

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF

Dutasteride

Therapeutic Category:

Urology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF

Doxazosin Mesylate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF

Donepezil HCl

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, EUDMF, Korea DMF

Dimethyl Fumarate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, EUDMF, Brazil DMF, China DMF

Deucravacitinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Desloratadine

Therapeutic Category:

Respiratory

Dose Form:

Syrup, Reditab

Regulatory Filing:

USDMF, CEP Submitted, EUDMF

Decitabine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, Korea DMF

Dasatinib (Monohydrate)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, Taiwan DMF

Darolutamide

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Dapagliflozin (PG Solvate Monohydrate)

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, Russia DMF, China DMF

Dapagliflozin (Amorphous)

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solids

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, Russia DMF

Dabigatran Etexilate Mesylate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, China DMF, CEP Submitted, Russia DMF

Clopidogrel Bisulfate (Form 2)

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Russia DMF, China DMF

Clopidogrel Bisulfate (Form 1)

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Russia DMF, China DMF

Ciprofloxacin Hydrochloride

Therapeutic Category:

Anti-Infective

Dose Form:

Oral Solids

Regulatory Filing:

Cinacalcet Hydrochloride

Therapeutic Category:

Endocrinology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Russia DMF, Brazil DMF, China DMF

Cetirizine Dihydrochloride

Therapeutic Category:

Respiratory

Dose Form:

Oral Solids, Liquid, Opthalmic

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Korea DMF, Russia DMF

Carfilzomib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF, China DMF

Capecitabine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Russia DMF, Korea DMF, China DMF

Cabozantinib S-Malate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, Korea DMF

Cabozantinib HCl

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Cabazitaxel

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Russia DMF

Bortezomib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Russia DMF

Benztropine Mesylate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets, Injectable

Regulatory Filing:

USDMF

Bendamustine Hydrochloride

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF

Bempedoic Acid

Therapeutic Category:

Cardiovascular

Dose Form:

Cardiovascular

Regulatory Filing:

Brazil DMF

Azacitidine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Powder

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Atorvastatin Calcium (Amorphous And Form 1)

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Russia DMF, China DMF

Atomoxetine Hydrochloride

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Canada DMF

Apremilast (Amorphous & Form B)

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF

Apixaban

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, Korea DMF, China DMF

Apalutamide (Amorphous & Form B)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Brazil DMF, USDMF

Amlodipine Besylate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Adagrasib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Acalabrutinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Abiraterone Acetate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF, Russia DMF

Active Pharmaceutical Ingredient

High-purity raw ingredients for pharmaceutical manufacturing.

Rimegepant

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Resmetirom

Therapeutic Category:

Non-alcoholic Steatohepatitis

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Relugolix

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets, Injectable

Regulatory Filing:

USDMF, Brazil DMF

Ramipril

Therapeutic Category:

Cardiovascular

Dose Form:

Capsule/ Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Russia DMF, China DMF

Raloxifene Hydrochloride

Therapeutic Category:

Musculoskeletal

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Canada DMF, Korea DMF, China DMF

Rabeprazole Sodium (Amorphous & Form Y)

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Capsule/ Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Russia DMF, China DMF

Quetiapine Fumarate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Korea DMF, China DMF, Japan DMF

Pregabalin

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Capsule/ Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Posaconazole

Therapeutic Category:

Anti-Infective

Dose Form:

Suspension/Oral Tablet, Delayed released tablets and solution

Regulatory Filing:

USDMF

Pomalidomide

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Pirtobrutinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Pioglitazone Hydrochloride

Therapeutic Category:

Anti-Diabetic

Dose Form:

Dose Form Oral Solid/Tablets

Regulatory Filing:

Brazil DMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, China DMF

Permethrin

Therapeutic Category:

Anti-Infective

Dose Form:

Lotion (Topical)

Regulatory Filing:

USDMF, CEP Submitted, EUDMF, Korea DMF

Perfluorohexyloctane

Therapeutic Category:

Opthamology

Dose Form:

Ophthalmic Solution

Regulatory Filing:

Pemetrexed Disodium Heptahydrate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Powder

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Pazopanib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Taiwan DMF

Pantoprazole Sodium

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Suspension/Oral Tablet, Injectable

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, China DMF

Palonosetron Hydrochloride

Therapeutic Category:

Oncology/ Anti-Emetics

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Korea DMF

Palbociclib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Capsule/ Tablet, Oral Solids

Regulatory Filing:

Brazil DMF, USDMF, Singapore DMF

Ondansetron Hydrochloride

Therapeutic Category:

Oncology/ Anti-Emetics

Dose Form:

Injection/Solution/Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, China DMF

Ondansetron Base

Therapeutic Category:

Oncology/ Anti-Emetics

Dose Form:

Injection/Solution/Tablet

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF

Omeprazole Magnesium

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, EUDMF

Omeprazole

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Korea DMF

Olaparib (Form A)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Capsule/ Tablet

Regulatory Filing:

China DMF, USDMF, Brazil DMF

Nizatidine

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Available Regulatory Filing USDMF, CEP Submitted, Japan DMF, Korea DMF

Niraparib Tosylate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Nilotinib Hydrochloride Monohydrate (Form B)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Korea DMF, China DMF

Naratriptan Hydrochloride

Therapeutic Category:

Pain Management

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF

Naproxen Sodium

Therapeutic Category:

Pain Management

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Korea DMF, Russia DMF

Naproxen

Therapeutic Category:

Pain Management

Dose Form:

Suspension/Oral Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Moxifloxacin Hydrochloride (Anhydrous)

Therapeutic Category:

Anti-Infective

Dose Form:

Oral Solids, Injectable, Opthalmic

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Korea DMF, Russia DMF, Egypt DMF

Montelukast Sodium

Therapeutic Category:

Respiratory

Dose Form:

Granular, Tablet or Chewable

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, China DMF, Japan DMF

Mirabegron (Alpha)

Therapeutic Category:

Urology

Dose Form:

ER Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, China DMF, CEP Submitted

Midostaurin

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Soft Gel Capsule, Oral Solids

Regulatory Filing:

USDMF, Brazil DMF

Metoprolol Succinate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, China DMF

Memantine Hydrochloride

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules, Solution/Tablet

Regulatory Filing:

USDMF, Canada DMF, Russia DMF, China DMF

Mavacamten

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Lurasidone Hydrochloride

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, China DMF

Lumateperone Tosylate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF

Lubiprostone

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Losartan Potassium

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Japan DMF, Russia DMF

Lomustine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, CEP Submitted, Russia DMF, China DMF

Liraglutide

Therapeutic Category:

Anti-Diabetic

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Brazil DMF

Linagliptin

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF

Lifitegrast

Therapeutic Category:

Opthamology

Dose Form:

Opthalmic

Regulatory Filing:

USDMF

Levofloxacin Hemihydrate

Therapeutic Category:

Anti-Infective

Dose Form:

Injection/Solution/Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Korea DMF, Russia DMF

Levocetirizine Dihydrochloride

Therapeutic Category:

Respiratory

Dose Form:

Solution/Tablet

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF, CEP Submitted

Levetiracetam

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Hard Gelatin Capsule/Tablet for Suspension

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, China DMF

Lenvatinib Mesylate (Form-C)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, Korea DMF

Lenvatinib Mesylate ( MIBK Solvate)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, Korea DMF

Lenalidomide (Form A)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Russia DMF, Brazil DMF, USDMF, EUDMF, Canada DMF, China DMF, Japan DMF

Lacidipine

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solids

Regulatory Filing:

EUDMF

Ketorolac Tromethamine

Therapeutic Category:

Pain Management

Dose Form:

Dose Form Nasal

Regulatory Filing:

China DMF, USDMF, CEP Submitted, Brazil DMF, Korea DMF, Russia DMF

Iron Sucrose

Therapeutic Category:

Nephrology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF

Granisteron

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Subcutaeous Injection

Regulatory Filing:

USDMF, EUDMF, Korea DMF

Glimepiride

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted

Gemcitabine Hydrochloride

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF, CEP Submitted, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Gatifloxacin (Anhydrous)

Therapeutic Category:

Anti-Infective

Dose Form:

Opthalmic

Regulatory Filing:

Brazil DMF, USDMF

Fruquintinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Fosaprepitant

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF

Fondaparinux Sodium

Therapeutic Category:

Cardiovascular

Dose Form:

Injectable

Regulatory Filing:

USDMF, Canada DMF, EUDMF, China DMF

Finasteride (Form III)

Therapeutic Category:

Urology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF

Finasteride (Form 1)

Therapeutic Category:

Urology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Fezolinetant

Therapeutic Category:

Gyneacology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Fexofenadine Hydrochloride (Form 1)

Therapeutic Category:

Respiratory

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Japan DMF, Korea DMF

Ferric Carboxymaltose

Therapeutic Category:

Nephrology

Dose Form:

Injectable

Regulatory Filing:

USDMF, China DMF, Malaysia DMF, Saudi Arabia

Famotidine

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solids

Regulatory Filing:

USDMF, CEP Submitted

Ezetimibe

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solids

Regulatory Filing:

USDMF, Brazil DMF

Eszopiclone

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF

Esomeprazole Magnesium Trihydrate

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules, Suspension

Regulatory Filing:

USDMF, CEP Submitted, EUDMF, Canada DMF, China DMF, Brazil DMF

Eslicarbazepine Acetate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, EUDMF

Eribulin

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Canada DMF

Enzalutamide

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Soft Gel Capsule

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, China DMF

Empagliflozin

Therapeutic Category:

Others

Dose Form:

Liquid

Regulatory Filing:

USA, Europe, Korea DMF, Canada DMF

Elinzanetant

Therapeutic Category:

Women's Health

Dose Form:

Tablets

Regulatory Filing:

Elagolix Sodium

Therapeutic Category:

Pain Management

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF

Edaravone

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF

Dutasteride

Therapeutic Category:

Urology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF

Doxazosin Mesylate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF

Donepezil HCl

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, EUDMF, Korea DMF

Dimethyl Fumarate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, EUDMF, Brazil DMF, China DMF

Deucravacitinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Desloratadine

Therapeutic Category:

Respiratory

Dose Form:

Syrup, Reditab

Regulatory Filing:

USDMF, CEP Submitted, EUDMF

Decitabine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, Korea DMF

Dasatinib (Monohydrate)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, Taiwan DMF

Darolutamide

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Dapagliflozin (PG Solvate Monohydrate)

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, Russia DMF, China DMF

Dapagliflozin (Amorphous)

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solids

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, Russia DMF

Dabigatran Etexilate Mesylate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, China DMF, CEP Submitted, Russia DMF

Clopidogrel Bisulfate (Form 2)

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Russia DMF, China DMF

Clopidogrel Bisulfate (Form 1)

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Russia DMF, China DMF

Ciprofloxacin Hydrochloride

Therapeutic Category:

Anti-Infective

Dose Form:

Oral Solids

Regulatory Filing:

Cinacalcet Hydrochloride

Therapeutic Category:

Endocrinology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Russia DMF, Brazil DMF, China DMF

Cetirizine Dihydrochloride

Therapeutic Category:

Respiratory

Dose Form:

Oral Solids, Liquid, Opthalmic

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Korea DMF, Russia DMF

Carfilzomib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF, China DMF

Capecitabine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Russia DMF, Korea DMF, China DMF

Cabozantinib S-Malate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, Korea DMF

Cabozantinib HCl

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Cabazitaxel

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Russia DMF

Bortezomib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Russia DMF

Benztropine Mesylate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets, Injectable

Regulatory Filing:

USDMF

Bendamustine Hydrochloride

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF

Bempedoic Acid

Therapeutic Category:

Cardiovascular

Dose Form:

Cardiovascular

Regulatory Filing:

Brazil DMF

Azacitidine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Powder

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Atorvastatin Calcium (Amorphous And Form 1)

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Russia DMF, China DMF

Atomoxetine Hydrochloride

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Canada DMF

Apremilast (Amorphous & Form B)

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF

Apixaban

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, Korea DMF, China DMF

Apalutamide (Amorphous & Form B)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Brazil DMF, USDMF

Amlodipine Besylate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Adagrasib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Acalabrutinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Abiraterone Acetate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF, Russia DMF

Active Pharmaceutical Ingredient

High-purity raw ingredients for pharmaceutical manufacturing.

Rimegepant

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Resmetirom

Therapeutic Category:

Non-alcoholic Steatohepatitis

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Relugolix

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets, Injectable

Regulatory Filing:

USDMF, Brazil DMF

Ramipril

Therapeutic Category:

Cardiovascular

Dose Form:

Capsule/ Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Russia DMF, China DMF

Raloxifene Hydrochloride

Therapeutic Category:

Musculoskeletal

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Canada DMF, Korea DMF, China DMF

Rabeprazole Sodium (Amorphous & Form Y)

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Capsule/ Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Russia DMF, China DMF

Quetiapine Fumarate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Korea DMF, China DMF, Japan DMF

Pregabalin

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Capsule/ Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Posaconazole

Therapeutic Category:

Anti-Infective

Dose Form:

Suspension/Oral Tablet, Delayed released tablets and solution

Regulatory Filing:

USDMF

Pomalidomide

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Pirtobrutinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Pioglitazone Hydrochloride

Therapeutic Category:

Anti-Diabetic

Dose Form:

Dose Form Oral Solid/Tablets

Regulatory Filing:

Brazil DMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, China DMF

Permethrin

Therapeutic Category:

Anti-Infective

Dose Form:

Lotion (Topical)

Regulatory Filing:

USDMF, CEP Submitted, EUDMF, Korea DMF

Perfluorohexyloctane

Therapeutic Category:

Opthamology

Dose Form:

Ophthalmic Solution

Regulatory Filing:

Pemetrexed Disodium Heptahydrate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Powder

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Pazopanib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Taiwan DMF

Pantoprazole Sodium

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Suspension/Oral Tablet, Injectable

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, China DMF

Palonosetron Hydrochloride

Therapeutic Category:

Oncology/ Anti-Emetics

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Korea DMF

Palbociclib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Capsule/ Tablet, Oral Solids

Regulatory Filing:

Brazil DMF, USDMF, Singapore DMF

Ondansetron Hydrochloride

Therapeutic Category:

Oncology/ Anti-Emetics

Dose Form:

Injection/Solution/Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, China DMF

Ondansetron Base

Therapeutic Category:

Oncology/ Anti-Emetics

Dose Form:

Injection/Solution/Tablet

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF

Omeprazole Magnesium

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, EUDMF

Omeprazole

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Korea DMF

Olaparib (Form A)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Capsule/ Tablet

Regulatory Filing:

China DMF, USDMF, Brazil DMF

Nizatidine

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Available Regulatory Filing USDMF, CEP Submitted, Japan DMF, Korea DMF

Niraparib Tosylate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Nilotinib Hydrochloride Monohydrate (Form B)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Korea DMF, China DMF

Naratriptan Hydrochloride

Therapeutic Category:

Pain Management

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF

Naproxen Sodium

Therapeutic Category:

Pain Management

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Korea DMF, Russia DMF

Naproxen

Therapeutic Category:

Pain Management

Dose Form:

Suspension/Oral Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Moxifloxacin Hydrochloride (Anhydrous)

Therapeutic Category:

Anti-Infective

Dose Form:

Oral Solids, Injectable, Opthalmic

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Korea DMF, Russia DMF, Egypt DMF

Montelukast Sodium

Therapeutic Category:

Respiratory

Dose Form:

Granular, Tablet or Chewable

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, China DMF, Japan DMF

Mirabegron (Alpha)

Therapeutic Category:

Urology

Dose Form:

ER Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, China DMF, CEP Submitted

Midostaurin

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Soft Gel Capsule, Oral Solids

Regulatory Filing:

USDMF, Brazil DMF

Metoprolol Succinate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, China DMF

Memantine Hydrochloride

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules, Solution/Tablet

Regulatory Filing:

USDMF, Canada DMF, Russia DMF, China DMF

Mavacamten

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Lurasidone Hydrochloride

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, China DMF

Lumateperone Tosylate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF

Lubiprostone

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Losartan Potassium

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Japan DMF, Russia DMF

Lomustine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, CEP Submitted, Russia DMF, China DMF

Liraglutide

Therapeutic Category:

Anti-Diabetic

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Brazil DMF

Linagliptin

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF

Lifitegrast

Therapeutic Category:

Opthamology

Dose Form:

Opthalmic

Regulatory Filing:

USDMF

Levofloxacin Hemihydrate

Therapeutic Category:

Anti-Infective

Dose Form:

Injection/Solution/Tablet

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Korea DMF, Russia DMF

Levocetirizine Dihydrochloride

Therapeutic Category:

Respiratory

Dose Form:

Solution/Tablet

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF, CEP Submitted

Levetiracetam

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Hard Gelatin Capsule/Tablet for Suspension

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, China DMF

Lenvatinib Mesylate (Form-C)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, Korea DMF

Lenvatinib Mesylate ( MIBK Solvate)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, Korea DMF

Lenalidomide (Form A)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Russia DMF, Brazil DMF, USDMF, EUDMF, Canada DMF, China DMF, Japan DMF

Lacidipine

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solids

Regulatory Filing:

EUDMF

Ketorolac Tromethamine

Therapeutic Category:

Pain Management

Dose Form:

Dose Form Nasal

Regulatory Filing:

China DMF, USDMF, CEP Submitted, Brazil DMF, Korea DMF, Russia DMF

Iron Sucrose

Therapeutic Category:

Nephrology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF

Granisteron

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Subcutaeous Injection

Regulatory Filing:

USDMF, EUDMF, Korea DMF

Glimepiride

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted

Gemcitabine Hydrochloride

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF, CEP Submitted, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Gatifloxacin (Anhydrous)

Therapeutic Category:

Anti-Infective

Dose Form:

Opthalmic

Regulatory Filing:

Brazil DMF, USDMF

Fruquintinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Fosaprepitant

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF

Fondaparinux Sodium

Therapeutic Category:

Cardiovascular

Dose Form:

Injectable

Regulatory Filing:

USDMF, Canada DMF, EUDMF, China DMF

Finasteride (Form III)

Therapeutic Category:

Urology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF

Finasteride (Form 1)

Therapeutic Category:

Urology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Fezolinetant

Therapeutic Category:

Gyneacology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Fexofenadine Hydrochloride (Form 1)

Therapeutic Category:

Respiratory

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Japan DMF, Korea DMF

Ferric Carboxymaltose

Therapeutic Category:

Nephrology

Dose Form:

Injectable

Regulatory Filing:

USDMF, China DMF, Malaysia DMF, Saudi Arabia

Famotidine

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solids

Regulatory Filing:

USDMF, CEP Submitted

Ezetimibe

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solids

Regulatory Filing:

USDMF, Brazil DMF

Eszopiclone

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF

Esomeprazole Magnesium Trihydrate

Therapeutic Category:

Gastro-Intestinal - GI

Dose Form:

Oral Solid/Capsules, Suspension

Regulatory Filing:

USDMF, CEP Submitted, EUDMF, Canada DMF, China DMF, Brazil DMF

Eslicarbazepine Acetate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, EUDMF

Eribulin

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Canada DMF

Enzalutamide

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Soft Gel Capsule

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, China DMF

Empagliflozin

Therapeutic Category:

Others

Dose Form:

Liquid

Regulatory Filing:

USA, Europe, Korea DMF, Canada DMF

Elinzanetant

Therapeutic Category:

Women's Health

Dose Form:

Tablets

Regulatory Filing:

Elagolix Sodium

Therapeutic Category:

Pain Management

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF

Edaravone

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF

Dutasteride

Therapeutic Category:

Urology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF

Doxazosin Mesylate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF

Donepezil HCl

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, EUDMF, Korea DMF

Dimethyl Fumarate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, EUDMF, Brazil DMF, China DMF

Deucravacitinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Desloratadine

Therapeutic Category:

Respiratory

Dose Form:

Syrup, Reditab

Regulatory Filing:

USDMF, CEP Submitted, EUDMF

Decitabine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, Korea DMF

Dasatinib (Monohydrate)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, Taiwan DMF

Darolutamide

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Dapagliflozin (PG Solvate Monohydrate)

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, Russia DMF, China DMF

Dapagliflozin (Amorphous)

Therapeutic Category:

Anti-Diabetic

Dose Form:

Oral Solids

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, Russia DMF

Dabigatran Etexilate Mesylate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, China DMF, CEP Submitted, Russia DMF

Clopidogrel Bisulfate (Form 2)

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Russia DMF, China DMF

Clopidogrel Bisulfate (Form 1)

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Russia DMF, China DMF

Ciprofloxacin Hydrochloride

Therapeutic Category:

Anti-Infective

Dose Form:

Oral Solids

Regulatory Filing:

Cinacalcet Hydrochloride

Therapeutic Category:

Endocrinology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Russia DMF, Brazil DMF, China DMF

Cetirizine Dihydrochloride

Therapeutic Category:

Respiratory

Dose Form:

Oral Solids, Liquid, Opthalmic

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Korea DMF, Russia DMF

Carfilzomib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF, China DMF

Capecitabine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, Canada DMF, Japan DMF, Russia DMF, Korea DMF, China DMF

Cabozantinib S-Malate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Brazil DMF, Korea DMF

Cabozantinib HCl

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF

Cabazitaxel

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Russia DMF

Bortezomib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, EUDMF, Canada DMF, Russia DMF

Benztropine Mesylate

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets, Injectable

Regulatory Filing:

USDMF

Bendamustine Hydrochloride

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Injectable

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF

Bempedoic Acid

Therapeutic Category:

Cardiovascular

Dose Form:

Cardiovascular

Regulatory Filing:

Brazil DMF

Azacitidine

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Powder

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Atorvastatin Calcium (Amorphous And Form 1)

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Brazil DMF, EUDMF, Canada DMF, Japan DMF, Russia DMF, China DMF

Atomoxetine Hydrochloride

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

USDMF, Canada DMF

Apremilast (Amorphous & Form B)

Therapeutic Category:

Central Nervous System (CNS)

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF

Apixaban

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, Canada DMF, Korea DMF, China DMF

Apalutamide (Amorphous & Form B)

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Brazil DMF, USDMF

Amlodipine Besylate

Therapeutic Category:

Cardiovascular

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, CEP Submitted, Canada DMF, Japan DMF, Korea DMF, Russia DMF, China DMF

Adagrasib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

Acalabrutinib

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Capsules

Regulatory Filing:

Abiraterone Acetate

Therapeutic Category:

Anti-Cancer/ Oncology

Dose Form:

Oral Solid/Tablets

Regulatory Filing:

USDMF, Brazil DMF, EUDMF, Korea DMF, Russia DMF