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 |
| 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 | - |