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.