Active Pharmaceutical Ingredient
High-purity raw ingredients for pharmaceutical manufacturing.
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
Active Pharmaceutical Ingredient
High-purity raw ingredients for pharmaceutical manufacturing.
High-purity raw ingredients for pharmaceutical manufacturing.
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
Active Pharmaceutical Ingredient
High-purity raw ingredients for pharmaceutical manufacturing.
High-purity raw ingredients for pharmaceutical manufacturing.
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.
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