Suppliers / FDC Limited

FDC Limited

India reconciled across 20 public records · 8 entities Updated 9 July 2026

FDC Limited is an API and finished-dose manufacturer based in India. It holds 15 active US drug master files and 16 valid CEPs across a filed portfolio of 20 molecules. Its filings concentrate with TMDA (TZ), SAHPRA (ZA) and MCAZ (ZW). Its GMP standing is certified by EDQM, EMA and MHRA (UK), among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 24 March 2023 as NAI. Customs aggregates show $15.5M of exports covering 673 molecules to 64 destinations in 2025.

15
active US DMFs
16
valid CEPs
10
registered plants 4 with an FDA FEI number
198
filings across 18 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
4 of 4 confirmed
Inspections
8 of 8 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 24 March 2023 NAI US FDA
  • 12 February 2023 NAI US FDA
  • 16 August 2018 VAI US FDA
  • 4 May 2018 NAI US FDA
  • 1 July 2016 VAI US FDA
  • 11 February 2016 NAI US FDA
  • 5 March 2015 VAI US FDA
  • 6 May 2014 VAI US FDA
  • 7 February 2013 VAI US FDA
  • 21 February 2012 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Aurangabad, United Arab Emirates Not on file
Chhatrapati Sambhajinagar, India 3003204330
VERNA SALCETTE, India Not on file
AURANGABAD, India Not on file
VERNA, India Not on file
Solan, India 3004738570

4 further sites are on record.

What they file, and where

Molecule Regulators Docs
Flurbiprofen EDQM, SFDA (Saudi Arabia), US FDA 6
Miconazole EDQM, SFDA (Saudi Arabia), US FDA 6
Albuterol EDQM, SFDA (Saudi Arabia), US FDA 4
Cinnarizine EDQM, SFDA (Saudi Arabia), US FDA 4
Timolol EDQM, SFDA (Saudi Arabia), US FDA 4
Brimonidine EDQM, US FDA 3
Bromhexine EDQM, SFDA (Saudi Arabia) 3
Dorzolamide EDQM, US FDA 3
Econazole EDQM, US FDA 3
Latanoprost EDQM, US FDA 3
Show all 20 molecules on file
Betaxolol EDQM 2
Fluconazole EDQM 2
Glycopyrronium EDQM 2
Rupatadine EDQM 2
Arformoterol US FDA 1
Bimatoprost US FDA 1
Brinzolamide US FDA 1
Nepafenac US FDA 1
Olopatadine US FDA 1
Semaglutide US FDA 1

Also appears on these molecule pages

Albuterol API Amlodipine finished dose Arformoterol API Azithromycin finished dose Bimatoprost API Brimonidine API Brinzolamide API Bromhexine API Cefixime finished dose Cefuroxime Axetil finished dose Chlorphenamine finished dose Chlorpheniramine finished dose
Show 27 more molecule pages
Cinnarizine API Ciprofloxacin finished dose Cromoglicic Acid finished dose Dexamethasone finished dose Dextromethorphan finished dose Diphenhydramine finished dose Dorzolamide API Econazole API Fluconazole API Flurbiprofen API Gentamicin finished dose Glycopyrronium API Lactulose finished dose Latanoprost API Lidocaine finished dose Miconazole API Moxifloxacin finished dose Nepafenac API Ofloxacin finished dose Olopatadine API Phenylephrine finished dose Roxithromycin finished dose Rupatadine API Salbutamol API Semaglutide API Sodium Cromoglicate finished dose Timolol API

Filings and GMP by regulator

Regulator Filings GMP certificates
TMDA (TZ) 48 None
SAHPRA (ZA) 34 None
MCAZ (ZW) 30 None
EFDA (ET) 26 None
MHRA (UK) 19 4
EMA 17 4
EDQM None 16
CDSCO (India) None 2
FDA (GH) None 2
ZAMRA (ZM) None 2
NAFDAC (NG) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $7.0M 62
2025 Not reported $15.5M 64
2024 Not reported $13.6M 66
2023 Not reported $78.7M 58

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about FDC Limited

Does FDC Limited hold a US DMF or a CEP?
FDC Limited holds 15 active US drug master files and 16 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is FDC Limited FDA-registered?
4 sites operated by FDC Limited carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did FDC Limited's last inspection go?
The most recent inspection on record closed on 24 March 2023 as NAI (No Action Indicated: nothing objectionable was found). 10 inspections are on file.
Where does FDC Limited manufacture?
10 registered sites are on record, in United Arab Emirates and India (Aurangabad, Chhatrapati Sambhajinagar and Verna Salcette among others). Every site is listed on this page with the register it came from.
What does FDC Limited make?
20 molecules are on record against FDC Limited, including Flurbiprofen, Miconazole, Albuterol and Cinnarizine. Each links through to that molecule's full manufacturer list.
Which regulators recognise FDC Limited's GMP?
Current GMP certificates are on record from EDQM, EMA, MHRA (UK), CDSCO (India), FDA (GH) and 2 more. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was NAI, on 24 March 2023.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts