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 -
5 Dorzolamide Hydrochloride USP/EP Yes - - CEP applied Yes
6 Econazole Nitrate BP/EP/USP/IP Yes - - Yes -
7 Fluconazole USP/EP Yes - - - -
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 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 - - - Under Preparation -
15 Timolol Maleate BP/EP/USP/JP/IP Yes Yes Yes Yes -
16 Rupatadine Fumarate In-house - - - - -

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:

  1. Bimatoprost*
  2. Olopatadine HCl*
  3. Duloxetine
  4. Betaxolol*
  5. Voriconazole
  6. Tioconazole*
  7. Brinzolamide
  8. Riluzole
  9. Metoprolol
  10. Telmisartan*
  11. Olmesartan*
  12. Losartan*
  13. Valsartan
  14. Irbesartan
  15. Candesartan
  16. Glimepiride

* Technical packages are available, on request.