Piramal's Generic API division offers a wide range of Generic API Development solutions for both commercial and development supplies tailored to global markets. Beyond our existing product portfolio, we collaborate closely with clients to identify early generic opportunities, ensuring timely API availability to support regulatory filings and facilitate market entry.
With over 50 ready-to-offer APIs backed by DMF and other regulatory filings from our 4 US FDA-inspected sites, our product basket includes therapies across CNS, CVS, anti-infective, anti-diabetic, and robust peptide offerings.
Amiodarone Hydrochloride
Anti-arrhythmic
-
21694
Approved
Dronedarone Hydrochloride
Anti-arrhythmic
-
031486
-
Anagrelide
Platelet Reducing Agent
-
38181
-
Aprepitant
Anti-emetic
-
26065
Approved
Fosaprepitant Dimeglumine
Anti-emetic
-
31484
-
Azilsartan Kamedoxomil
Anti-hypersentive
-
35770
-
Bisoprolol Fumarate
Anti-hypersentive
-
29123
Approved
Diltiazem Hydrochloride
Anti-hypersentive
-
14713
Approved
Lercanidipine
Anti-hypersentive
-
-
-
Verapamil Hydrochloride
Anti-hypersentive
-
16605
Approved
Baclofen
Muscle Relaxant
-
28455
Approved
Cinacalcet Hydrochloride
Calcimimetic
-
29162
-
Clobazam
Anti-convulsant
-
29164
-
Brivaracetam
Anti-convulsant
357336-20-0
-
-
dl-Cloprostenol*
Luteolytic Agent
-
15758
-
Dabigatran Etexilate Mesylate
Anti-coagulant
-
30404
Applied
Rivaroxaban
Anti-coagulant
-
30403
-
Edoxaban
Anti-coagulant
1229194-11-9
-
-
Dapagliflozin Propanediol Monohydrate
Anti-diabetic
-
33282
-
Empagliflozin
Anti-diabetic
-
33545
-
Deferasirox
Iron Chelator
-
31485
-
Dexlansoprazole
Anti-ulcerant
-
33685
-
Misoprostol
Anti-ulcerant
-
21188
Approved
Donepezil Hydrochloride
Anti-alzheimer’s
-
27650
-
Droxidopa
Anti-parkinson
-
34258
-
Pramipexole Dihyrochloride Monohydrate
Anti-parkinson
-
30186
Approved
Ketoconazole
Anti-fungal
-
17290
Approved
Levoketoconazole
Cushing’s Syndrome
-
38973
-
Lurasidone Hydrochloride
Anti-psychotic
-
29163
-
Mebeverine Hydrochloride
Anti-spasmodic
-
-
Approved
Mirabegron
Urinary Incontinence
-
33281
Applied
Monusulfiram
Ectoparasiticide
-
-
-
Spironolactone
Diuretic
-
-
Approved
Tetrabenazene
Hyperkinetic Movement Disorder
-
32450
-
Trazodone Hydrochloride
Anti-depressant
-
20920
Approved
Vortioxetine Hydrobromide
Anti-depressant
-
35801
-
Desvenlafaxine Succinate Monohydrate
Anti-depressant
386750-22-7
-
-
Varenicline Tartrate
Nicotinic Antagonist
-
34116
-
Apremilast
Anti-arthritic/Anti-psoriasis
608141-41-9
-
-
Bilastine
Anti-histamine
202189-78-4
-
-
Dexmedetomidine
Sedative/Anaesthetics
145108-58-3
-
-
| Product Name | Category | CAS NO | US-DMF | CEP/ASMF | |
|---|---|---|---|---|---|
| Amiodarone Hydrochloride | Anti-arrhythmic | - | 21694 | Approved | ORDER |
| Dronedarone Hydrochloride | Anti-arrhythmic | - | 031486 | - | ORDER |
| Anagrelide | Platelet Reducing Agent | - | 38181 | - | ORDER |
| Aprepitant | Anti-emetic | - | 26065 | Approved | ORDER |
| Fosaprepitant Dimeglumine | Anti-emetic | - | 31484 | - | ORDER |
| Azilsartan Kamedoxomil | Anti-hypersentive | - | 35770 | - | ORDER |
| Bisoprolol Fumarate | Anti-hypersentive | - | 29123 | Approved | ORDER |
| Diltiazem Hydrochloride | Anti-hypersentive | - | 14713 | Approved | ORDER |
| Lercanidipine | Anti-hypersentive | - | - | - | ORDER |
| Verapamil Hydrochloride | Anti-hypersentive | - | 16605 | Approved | ORDER |
| Baclofen | Muscle Relaxant | - | 28455 | Approved | ORDER |
| Cinacalcet Hydrochloride | Calcimimetic | - | 29162 | - | ORDER |
| Clobazam | Anti-convulsant | - | 29164 | - | ORDER |
| Brivaracetam | Anti-convulsant | 357336-20-0 | - | - | ORDER |
| dl-Cloprostenol* | Luteolytic Agent | - | 15758 | - | ORDER |
| Dabigatran Etexilate Mesylate | Anti-coagulant | - | 30404 | Applied | ORDER |
| Rivaroxaban | Anti-coagulant | - | 30403 | - | ORDER |
| Edoxaban | Anti-coagulant | 1229194-11-9 | - | - | ORDER |
| Dapagliflozin Propanediol Monohydrate | Anti-diabetic | - | 33282 | - | ORDER |
| Empagliflozin | Anti-diabetic | - | 33545 | - | ORDER |
| Deferasirox | Iron Chelator | - | 31485 | - | ORDER |
| Dexlansoprazole | Anti-ulcerant | - | 33685 | - | ORDER |
| Misoprostol | Anti-ulcerant | - | 21188 | Approved | ORDER |
| Donepezil Hydrochloride | Anti-alzheimer’s | - | 27650 | - | ORDER |
| Droxidopa | Anti-parkinson | - | 34258 | - | ORDER |
| Pramipexole Dihyrochloride Monohydrate | Anti-parkinson | - | 30186 | Approved | ORDER |
| Ketoconazole | Anti-fungal | - | 17290 | Approved | ORDER |
| Levoketoconazole | Cushing’s Syndrome | - | 38973 | - | ORDER |
| Lurasidone Hydrochloride | Anti-psychotic | - | 29163 | - | ORDER |
| Mebeverine Hydrochloride | Anti-spasmodic | - | - | Approved | ORDER |
| Mirabegron | Urinary Incontinence | - | 33281 | Applied | ORDER |
| Monusulfiram | Ectoparasiticide | - | - | - | ORDER |
| Spironolactone | Diuretic | - | - | Approved | ORDER |
| Tetrabenazene | Hyperkinetic Movement Disorder | - | 32450 | - | ORDER |
| Trazodone Hydrochloride | Anti-depressant | - | 20920 | Approved | ORDER |
| Vortioxetine Hydrobromide | Anti-depressant | - | 35801 | - | ORDER |
| Desvenlafaxine Succinate Monohydrate | Anti-depressant | 386750-22-7 | - | - | ORDER |
| Varenicline Tartrate | Nicotinic Antagonist | - | 34116 | - | ORDER |
| Apremilast | Anti-arthritic/Anti-psoriasis | 608141-41-9 | - | - | ORDER |
| Bilastine | Anti-histamine | 202189-78-4 | - | - | ORDER |
| Dexmedetomidine | Sedative/Anaesthetics | 145108-58-3 | - | - | ORDER |
Piramal's Digwal facility offers services for developing and commercial manufacturing of APIs (NCEs & Generics) and key intermediates. This facility has three manufacturing areas with 12+ multi-purpose production blocks. It has a total volumetric capacity of over 750 kL, housing 245 reactors. The facility has received regulatory accreditations from USFDA, EDQM, AIFA, and KFDA.
Piramal’s Turbhe facility offers strong expertise in the development and commercial manufacturing of both solution phase and solid phase synthesis of peptides. We also offer a portfolio of generic peptide APIs from multigram to kilogram scale. The facility is accredited by USFDA, EDQM, AIFA and KFDA.
Piramal's Ennore facility provides process development and early-phase clinical supplies for NCEs, as well as custom manufacturing services for RSMs, KSMs, and intermediates. The plant has a total capacity of 200+ MT per year. The facility has received regulatory accreditations from WHO GMP and India FDA
Piramal's Aurora site specializes in route selection, process development, and manufacturing of APIs. The site is primarily comprised of Research and Development, Analytical Development, Analytical Services, Quality Control labs and three manufacturing areas.
We have a long-standing regulatory history with the US FDA, Health Canada, and PMDA Japan and are fully compliant with all applicable regulations, safety, and environmental standards.
