To develop cost-effective, environment-friendly, high-quality APIs meeting stringent ICH standards is the main focus of FDC’s API division.
Our products and manufacturing facilities have been inspected and approved multiple times by major Regulatory bodies such as US-FDA and WHO-GMP.
Till date we have developed over twenty-three APIs of which fourteen have already been commercialized and exported across the world. We have filed 11 USDMFs and 6 CEPs for APIs.
The APIs produced cover a broad range of therapeutic categories as listed below:
List of Active Pharmaceutical Ingredients (APIs)
| Sr. No. | API | Specification | US DMF | Canadian DMF | J-DMF | CEP | EDMF | |
|---|---|---|---|---|---|---|---|---|
| 1 | Albuterol Sulfate | USP | Yes | - | - | - | - | |
| 2 | Brimonidine Tartrate | In-house/EP | Yes | - | - | Under Preparation | Yes | |
| 3 | Bromhexine Hydrochloride | BP/EP/JP/IP | - | - | - | Yes | - | |
| 4 | Cinnarizine | BP/EP/JP/IP | Yes | Yes | - | Yes | - | |
| 5 | Dorzolamide Hydrochloride | USP/EP | Yes | - | - | Yes | Yes | |
| 6 | Econazole Nitrate | BP/EP/USP/IP | Yes | - | - | Yes | - | |
| 7 | Fluconazole | USP/EP | Yes | - | - | Under Preparation | - | |
| 8 | Flunarizine Dihydrochloride | BP/EP/JP | - | - | - | - | - | |
| 9 | Flurbiprofen | BP/EP/USP/JP/IP | Yes | - | Yes | Yes | - | |
| 10 | Flurbiprofen Sodium | BP/EP/USP/JP | - | - | - | - | - | |
| 11 | Latanoprost | In-house / USP | Yes | - | - | - | Yes | |
| 12 | Miconazole Base | BP/EP/USP/JP/IP | Yes | - | - | - | Yes | |
| 13 | Miconazole Nitrate | BP/EP/USP/JP/IP | Yes | - | - | Yes | - | |
| 14 | Salbutamol Sulphate | BP/EP/JP/IP | - | - | - | Yes | - | |
| 15 | Timolol Maleate | BP/EP/USP/JP/IP | Yes | Yes | Yes | Yes | - | |
| 16 | Rupatadine Fumarate | In-house | - | - | - | - | - | |
| 17 | Olopatadine Hydrochloride | USP | Yes | Yes | ||||
| 18 | Telmisartan | BP/EP/JP/IP | Yes | Yes |
Contact Person :- Mr. Vinod Aair - International Business Dept - APIs.
E-mail :- vinod@fdcindia.com
Direct Phone No. :- +91-22-30719207.
Technical package is available for all APIs listed above. The APIs listed are offered for sale only in those countries where the manufacturing process is non-infringing any valid Process Patents, subject to Patent status verification by the client.
APIs under development:
- Bimatoprost*
- Olopatadine HCl*
- Duloxetine
- Betaxolol*
- Voriconazole
- Tioconazole*
- Brinzolamide
- Riluzole
- Metoprolol
- Telmisartan*
- Olmesartan*
- Losartan*
- Valsartan
- Irbesartan
- Candesartan
- Glimepiride
* Technical packages are available, on request.
