API

An Active Pharmaceutical Ingredient (API) is the core component of a pharmaceutical drug that produces the intended therapeutic effect. APIs are responsible for diagnosing, treating, curing, or preventing diseases, while excipients are inactive substances that support the drug’s delivery and stability. In the pharmaceutical industry, APIs can be derived from chemical synthesis, fermentation, biotechnology, or natural sources. The quality, purity, and consistency of APIs are critical, as they directly impact the safety and efficacy of medicines. API manufacturing follows strict regulatory guidelines such as Good Manufacturing Practices (GMP) to ensure compliance with global health authorities. APIs may be produced in bulk and supplied to formulation companies or integrated into finished dosage forms like tablets, capsules, and injections.

Product Name CAS No. DMF USDMF / CEP / WC Enquiry
Budesonide 51333-22-3 Available CEP 2024-441, E-DMF, WC available, CEP submitted.
Clenbuterol HCL 21898-19-1 Available MF040283/CEP 2020-172-REV 02, E-DMF, WC and CEP available
Cyproheptadine HCL 41354-29-4 Available MF040578/CEP 2024-359, E-DMF available, CEP submitted.
Dexamethasone 50-02-2 Available E-DMF available
Glycopyrronium Bromide 51186-83-5 Available CEP 2024-538, E-DMF, CEP submitted.
Haloperidol 52-86-8 Available MF034283/CEP 2020-149-REV 01, E-DMF available, US-DMF and WC available
Haloperidol Decanoate 74050-97-8 Available E-DMF available, CEP submitted.
Ipratropium Bromide 66985-17-9 Available MF040419/CEP 2023-137-REV 01, E-DMF, WC, CEP available
Loperamide HCL 34552-83-5 Available MF042591, E-DMF, US DMF available, CEP submitted
Mometasone Furoate Monohydrate 141646-00-6 Available EDMF available, CEP Under Submission
Sumatriptan Succinate 103628-48-4 Available CEP 2024-547, E-DMF, CEP SUBMITTED
Tiotropium Bromide Monohydrate 139404-48-1 Available MF034808/CEP 2012-285 - REV 03, USD DMF under process
Triamcinolone 124-94-7 Available E-DMF Available
Triamcinolone Acetonide 76-25-5 Available Under Submission
Product Name CAS No. USDMF / CEP / WC Enquiry
Budesonide 51333-22-3 CEP 2024-441, E-DMF, WC available
Clenbuterol HCL 21898-19-1 MF040283 / CEP 2020-172-REV 02
Cyproheptadine HCL 41354-29-4 MF040578 / CEP 2024-359
Dexamethasone 50-02-2 E-DMF available
Glycopyrronium Bromide 51186-83-5 CEP 2024-538, E-DMF, CEP submitted
Haloperidol 52-86-8 MF034283 / CEP 2020-149-REV 01, E-DMF, US-DMF and WC available
Haloperidol Decanoate 74050-97-8 E-DMF available, CEP submitted
Ipratropium Bromide 66985-17-9 MF040419 / CEP 2023-137-REV 01, E-DMF, WC, CEP available
Loperamide HCL 34552-83-5 MF042591, E-DMF, US-DMF available, CEP submitted
Mometasone Furoate Monohydrate 141646-00-6 EDMF available, CEP under submission
Carbidopa 28860-95-9 Non-USFDA
Dabigatran Etexilate Mesylate 872728-81-9 Non-USFDA
Fluconazole 86386-73-1 Non-USFDA
Itraconazole 84625-61-6 Non-USFDA
Lansoprazole 103577-45-3 Non-USFDA
Montelukast Sodium 151767-02-1 Non-USFDA
Nabumetone 42924-53-8 Non-USFDA
Quinapril Hydrochloride 82586-55-8 Non-USFDA
Risedronate Sodium 353228-19-0 Non-USFDA
Rosuvastatin Calcium 147098-20-2 Non-USFDA
Tapentadol Hydrochloride 175591-09-0 Non-USFDA
Etodolac 41340-25-4 Non-USFDA
Paliperidone 144598-75-4 Non-USFDA
Risperidone 106266-06-2 Non-USFDA
API Name Chemical Name CAS No. Enquiry
Dolutegravir Chloro acetaldehyde Dimethyl Acetal (CADMA) 97-97-2
Dolutegravir Amino acetaldehyde Dimethyl Acetal (AADMA) 22483-09-6
Dolutegravir 1-(2,2-dimethoxyethyl)-5-methoxy-6-(methoxycarbonyl)-4-oxo-1,4-dihydropyridine-3-carboxylic acid 1335210-23-5
Flurbiprofen Diethyl 2-[2-fluoro-4-biphenyl-4-yl]-2-methylmalonate 42771-81-3
Flurbiprofen 4-Bromo-2-fluorobiphenyl 41604-19-7
Duloxetine (S)-3-(Methylamino)-1-(2-thienyl)-1-propanol 116539-55-0
Duloxetine 1-Fluoronaphthalene 321-38-0
Fluoxetine N,N-Dimethyl-3-phenyl-3-hydroxypropylamine Hydrochloride 5424-50-0
Fluoxetine 3-(4-(Trifluoromethyl)phenoxy)-N,N-dimethyl-3-phenylpropan-1-amine 56225-81-1
Fluoxetine 3-(4-(Trifluoromethyl)phenoxy)-N,N-dimethyl-3-phenylpropan-1-amine 936-59-4
Fluoxetine N,N-Dimethyl-3-phenyl-3-hydroxy propylamine Hydrochloride 5554-64-3
Atomoxetine / Dopoxetine N,N-dimethyl-3-phenyl-3-(o-tolyloxy)propan-1-amine oxalate 107688-86-8
Atomoxetine / Dopoxetine 3-Chloro-1-phenyl-1-propanol 18776-12-0
Atomoxetine / Dopoxetine 3-(Methylamino)-1-phenylpropan-1-ol 42142-52-9
Linagliptin / Alogliptin (R)-3-Boc-aminopiperidine 309956-78-3
Linagliptin / Alogliptin (R)-(-)-3-Piperidinamine Dihydrochloride 334618-23-4
Nadolol cis-3a,4,9,9a-tetrahydro-2,2-dimethylnaphtho[2,3-d]-1,3-dioxol-5-ol 52187-19-6
Prasugrel 5,6,7,8-tetrahydronaphthalene-1,6,7-triol 344764-57-4
Prasugrel Cyclopropyl 2-Fluorobenzyl Ketone 150322-73-9
Prasugrel 2-Bromo-2-(2-fluorophenyl)-1-cyclopropylethanone 204205-33-4
Prasugrel 5-trityl-5,6,7,7a-tetrahydrothieno[3,2-c]pyridin-2(4H)-one 109904-26-9
Prasugrel 5,6,7,7a-Tetrahydrothieno[3,2-c]pyridine-2(4H)-one hydrochloride 115473-15-9
Telmisartan Methyl 4'-(bromomethyl)[1,1'-biphenyl]-2-carboxylate 114772-38-2
Eletriptan (R)-5-Bromo-3-((1-methylpyrrolidin-2-yl)methyl)-1H-indole 143322-57-0
Entacapone N,N-Diethylcyanoacetamide 26391-06-0
Entacapone 3,4-Dihydroxy-5-nitrobenzaldehyde 116313-85-0
Parecoxib 5-Methyl-3,4-diphenylisoxazole 37928-17-9
Valganciclovir 1,3-Diacetoxy-2-(acetoxy methoxy)propane 86357-13-3
Praziquantel N-Benzyl-2,2-dimethoxyethanamine 54879-88-8
Praziquantel 2-chloro-N-(2-phenylethyl)acetamide 13156-95-1
Celecoxib 4-sulfonamidophenylhydrazine hydrochloride 27918-19-0
Hydroxychloroquine 2-[(4-aminopentyl)(ethyl)amino]ethanol 69559-11-1
Hydroxychloroquine 4,7-Dichloroquinoline 86-98-6
Ziprasidone 6-chloro-2-oxindole 56341-37-8
Ziprasidone 3-(1-Piperazinyl)-1,2-benzisothiazole 87691-87-0
Rosuvastatin 1-Phenyl-1H-tetrazole-5-thiol 86-93-1
Dasatinib 2-Chloro-6-methylaniline 87-63-8
Midazolam 2-Aminomethyl-7-chloro-2,3-dihydro-5-(2-fluorophenyl)-1H-1,4-benzodiazepine dimaleate 59469-29-3
Hydralazine HCl 1-Phthalazinone 20055-18-9
Ractopamine HCl DL-Octopamine HCl 104-14-3
Abemaciclib 6-(2-Chloro-5-fluoropyrimidin-4-yl)-4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazole 1231930-42-9
Abemaciclib 5-((4-Ethylpiperazin-1-yl)methyl)pyridin-2-amine 1180132-17-5
Abemaciclib 6-Bromo-4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazole 1231930-33-8
Acalabrutinib (S)-Benzyl-2-(8-amino-1-bromoimidazo[1,5-a]pyrazin-3-yl)pyrrolidine-1-carboxylate 1420478-88-1
Acalabrutinib (4-(Pyridin-2-lcarbamoyl)phenyl)boronic acid 850568-25-1
Dabrafenib 2,6-Difluorobenzenesulfonyl Chloride 60230-36-6
Dabrafenib 2-Chloro-4-methylpyrimidine 13036-57-2
Dabrafenib 2,2-dimethylpropanethioamide 630-22-8
Dabrafenib Methyl 3-Amino-2-fluorobenzoate 1195768-18-3
Ivabradine (1S)-4,5-Dimethoxy-1-[(methylamino)methyl]benzocyclobutane Hydrochloride 866783-13-3
Riociguat 1-(2-Fluorobenzyl)-1H-pyrazolo[3,4-b]pyridine-3-carboximidamide Hydrochloride 256499-19-1
Ponatinib N-[4-(hydroxymethyl)-3-(trifluoromethyl)phenyl]-3-iodo-4-methylbenzamide 1488423-79-5
Ponatinib 3-Ethynylimidazo[1,2-b]pyridazine 943320-61-4
Momelotinib Ethyl 4-[2-[(4-(4-morpholinyl)phenyl)amino]-4-pyrimidinyl]benzoate 1056634-62-8
Momelotinib 1-[4-(4-Morpholinyl)phenyl]guanidine 247234-41-9
NA (E)-Methyl 4-(3-(dimethylamino)acryloyl)benzoate 114431-72-0
Alectinib tert-butyl 4-(4-ethyl-3-iodophenyl)-4-methyl-3-oxopentanoate 1256584-74-3
Fezolinetant 3-Methyl-1,2,4-thiadiazole-5-carbohydrazide 1375066-73-1
Enzalutamide 4-Bromo-2-fluoro-N-methylbenzamide 749927-69-3
Enzalutamide 2-((3-Fluoro-4-(methylcarbamoyl)phenyl)amino)-2-methylpropanoic acid 1289942-66-0
Vismodegib 2-(2-Chloro-5-nitrophenyl)pyridine 879088-40-1
Pirtobrutinib Potassium trifluoro((5-fluoro-2-methoxybenzamido)methyl)borate 2089246-64-8
Selexipag 4-(Isopropylamino)butanol 42042-71-7
Selexipag Methane sulfonamide 3144-09-0
Selexipag 1-Butanol,4-[(5,6-diphenyl-2-pyrazinyl)(1-methylethyl)amino] 475086-75-0
Selexipag 2-(4-((5,6-Diphenylpyrazin-2-yl)(isopropyl)amino)butoxy)acetic acid 475085-57-5
Lumateperone 4-Chloro-4'-fluorobutyrophenone 3874-54-2
Lumateperone (4aS,9bR)-Ethyl 6-bromo-5-(2-(methylamino)-2-oxoethyl)-3,4,4a,5-tetrahydro-1H-pyrido[4,3-b]indole-2(9bH)carboxylate 2098497-32-4
Mirabegron (R)-2-((4-aminophenethyl)amino)-1-phenylethanol hydrochloride 521284-22-0
Mirabegron (2-Amino-4-thiazolyl)acetic acid 29676-71-9
Mirabegron 2-(4-Nitrophenyl)ethylamine hydrochloride 29968-78-3
Azilsartan / Candesartan Methyl 1-[(2'-Cyano-[1,1'-biphenyl]-4-yl)methyl]-2-ethoxy-1H-benzo[d]imidazole-7-carboxylate 139481-44-0
Rivastigmine 3-[(1S)-1-(Dimethylamino)ethyl]phenol 139306-10-8
Pirtobrutinib Potassium trifluoro((5-fluoro-2-methylbenzamido)methyl)borate 2089246-64-8
Lotilaner (S)-3-Methyl-5-(5-(3,4,5-trichlorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl)thiophene-2-carboxylic acid 1918956-01-0
Lenvatinib 4-Chloro-7-methoxyquinoline-6-carboxamide 417721-36-9
Solifenacin (R)-(-)-3-Quinuclidinol 25333-42-0
Dorzolamide (3S)-3-(2-thienylthio)butanoic acid 133359-80-5
Dorzolamide (4R,6S)-6-Methyl-7,7-dioxo-5,6-dihydro-4H-thieno[2,3-b]thiopyran-4-ol 147128-77-6
Dorzolamide (4S-trans)-N-(5,6-dihydro-6-methyl-7,7-dioxido-4H-thieno[2,3-b]thiopyran-4-yl)-acetamide 147086-83-7
Product Name Pharmacopoeia Therapeutic Use Regulatory Approval Enquiry
Ursodeoxycholic Acid (UDCA) USP / EP / JP Antigout / Primary Biliary Cirrhosis ASMF / CEP
Atorvastatin Calcium (Crystalline) USP / EP / JP Lipid Lowering Agent ASMF / CEP
Atorvastatin Calcium (Amorphous) USP / EP / JP Lipid Lowering Agent CEP
Cetirizine Dihydrochloride USP / EP Antihistamine ASMF / CEP
Bromhexine Hydrochloride EP / BP Expectorant -
Milnacipran USP / JP Antidepressant -
Felbamate USP Anticonvulsant ASMF
Benztropine Mesylate USP Antiparkinsonian ASMF
Nitrofurantoin USP Antibacterial -
Prilocaine USP Anesthetic -
Flupirtine Maleate USP / EP / BP Analgesic ASMF
Diclofenac Sodium USP / EP / BP Analgesic ASMF / CEP
Mefenamic Acid USP / EP / BP Analgesic ASMF / CEP
Meloxicam USP / EP Analgesic ASMF / CEP
Piroxicam USP / EP Analgesic ASMF / CEP
S (+) Ibuprofen In-House Analgesic ASMF / CEP
Nabumetone USP Analgesic -
Artemether In-House Antimalarial -

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