After our first US-FDA inspection in 1985, we have undergone over 30 extensive audits by regulatory authorities including the US-FDA, UK-MHRA, SA-MCC and ANVISA (Brazil). Most importantly, our facilities have been approved by these authorities on every occasion.
FDC exports to over 50 countries, including advanced markets such as the US, UK, South Africa, and Japan. As an integrated pharmaceutical company – with world-class API and formulation capabilities – we offer a wide range of formulations, as well as APIs. Besides our oral solid and oral liquid formulations, our expertise in ophthalmic and Oral Rehydration Salts (ORS) dosage forms gives us extensive reach and penetration across continents. Our competence in product development, regulatory expertise and manufacturing built over several years of relentless efforts have made us a preferred supplier to global customers including non-profit organizations like UNICEF, IDA, MSF and PSI.
The various plant accreditations of FDC are as under :-
APIs
|
Sr. No. |
Address of the Manufacturing Unit |
Approving authority |
Manufacturing Section |
|---|---|---|---|
|
1 |
FDC Limited Plot No. 19 & 20/2, M.I.D.C. Industrial Area, Roha- 402 116, District Raigad, Maharashtra State, India |
USFDA |
APIs |
|
WHO INDIA |
APIs |
Finished Formulations
|
Sr. No. |
Address of the Manufacturing Unit |
Approving authority |
Manufacturing Section |
|---|---|---|---|
|
1 |
FDC Limited (Goa – I & Goa – II) L-56/57, Phase II-D, Verna Industrial Estate, Goa-403722, India |
UK MHRA |
Capsules and Tablets |
|
|
|
PPB KENYA |
Capsules, Tablets & dry powders |
|
|
|
STATE ADMINISTRATION OF UKRAINE ON MEDICINAL PRODUCTS |
Capsules and Tablets |
|
|
|
MEDECINS SANS FRONTIERES |
Capsules and Tablets |
|
|
|
WHO INDIA |
Capsules and Tablets |
|
|
|
|
|
|
2 |
FDC Limited (Goa – III) Phase III-A, Plot No.L-121/B, Salcette, Verna Industrial Estate, Verna, Goa-403722, INDIA |
UK MHRA |
Capsules and Tablets |
| PIC/S MALAYSIA | Tablets | ||
|
|
|
STATE ADMINISTRATION OF UKRAINE ON MEDICINAL PRODUCTS |
Capsules and Tablets |
|
|
|
MEDECINS SANS FRONTIERES |
Capsules and Tablets |
| PPB KENYA | Tablets | ||
|
|
|
WHO INDIA |
Capsules and Tablets |
|
|
|
FMHAC ETHIOPIA |
Capsules and Tablets |
|
3 |
FDC Limited Plot No.B-8, M.I.D.C.Industrial Area, Waluj-431136 (District Aurangabad), Maharashtra State, India |
USFDA |
Sterile Eye drops |
|
|
|
UK MHRA |
Sterile Eye drops |
|
|
|
PIC/S MALAYSIA |
Oral Liquids, Oral & External powders |
|
STATE SERVICE OF UKRAINE FOR MEDICINAL PRODUCTS AND DRUG CONTROL |
Oral Liquids, Oral and External Powders. | ||
| SULTANATE OF OMAN MINISTRY OF HEALTH | Ophthalmic preparations, Oral Rehydration Salts (ORS). | ||
|
|
|
MEDECINS SANS FRONTIERES |
Oral rehydration salts |
|
|
|
MCA ZIMBABWE |
Oral liquids & Oral powders only |
|
|
|
TFDA TANZANIA |
Sterile Eye drops, Liquid orals, Oral & External powders |
|
|
|
DACA ETHIOPIA |
Sterile Eye drops |
|
|
|
NDA UGANDA |
Oral liquids & Oral rehydration salts |
|
|
|
PPB KENYA |
Sterile ophthalmic liquids, Oral Liquids/suspensions, Oral rehydration salts/dry powders & external dry powders. |
|
|
|
MCC SOUTH AFRICA |
Sterile Eye drops |
|
|
|
WHO INDIA |
Sterile Eye drops, Liquid orals, Oral & External powders |
|
|
|
FDA PHILIPPINES |
Sterile Eye drops, Liquid orals, Oral & External powders. |
|
4 |
FDC Limited G-1, M.I.D.C. Industrial area, Sinnar 422 103, (District Nasik), State-Maharashtra, INDIA |
MEDECINS SANS FRONTIERES |
Oral rehydration salts |
|
|
|
UNICEF DENMARK |
Oral rehydration salts |
|
|
|
DACA ETHIOPIA |
Oral rehydration salts |
|
|
|
TFDA TANZANIA |
Oral rehydration salts |
|
|
|
PMPB MALAWI |
Oral rehydration salts |
|
|
|
WHO INDIA |
Oral rehydration salts |
|
|
|
|
|
|
5 |
FDC Limited Village Khol, Bund, Tahsil Nalaghar, Baddi, District: Solan (H.P)-173205. India |
USFDA |
Oral Cephalosporin Tablets line |
| WHO INDIA | Oral Cephalosporin products |
Efforts are made to increase our operations in the European and North American markets by partnering with established marketing companies and providing high-quality products. As a result, besides having several active US DMFs & ANDAs for ophthalmic solutions, many more ANDAs are in various phases of gaining approval in the US.
