Suppliers / Coral Drugs

Coral Drugs

India 137 employees reconciled across 1 public records · 1 entities Updated 9 July 2026

Coral Drugs is an API manufacturer based in India. It holds 15 active US drug master files across a filed portfolio of 10 molecules. Its GMP standing is certified by EDQM and EMA. Its most recent recorded inspection, by US FDA, closed on 11 December 2019 as VAI. Customs aggregates show $10.0M of exports covering 236 molecules to 38 destinations in 2025.

15
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 11 December 2019 VAI US FDA
  • 23 February 2018 VAI US FDA
  • 11 March 2016 VAI US FDA
  • 13 November 2010 VAI US FDA

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

Registered plants

Site FDA FEI
India, India 3003496619
Sonipat, India Not on file

What they file, and where

Molecule Regulators Docs
Budesonide SFDA (Saudi Arabia), US FDA 3
Mometasone Furoate US FDA 3
Fluticasone Furoate US FDA 2
Fluticasone Propionate US FDA 2
Triamcinolone US FDA 2
Azelastine US FDA 1
Ciclesonide US FDA 1
Deflazacort US FDA 1
Exemestane US FDA 1
Formoterol US FDA 1

Also appears on these molecule pages

Azelastine contract manufacturing Budesonide contract manufacturing Ciclesonide API Deflazacort API Exemestane contract manufacturing Formoterol contract manufacturing Mometasone contract manufacturing Salmeterol contract manufacturing Triamcinolone API Fluticasone API

Filings and GMP by regulator

Regulator Filings GMP certificates
EDQM None 15
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.5M 18
2025 Not reported $10.0M 38
2024 Not reported $8.2M 34
2023 Not reported $7.9M 26

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 We do not publish the identity of any buyer.

Questions about Coral Drugs

Does Coral Drugs hold a US DMF or a CEP?
Coral Drugs holds 15 active US drug master files. 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 Coral Drugs FDA-registered?
One site operated by Coral Drugs carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Coral Drugs's last inspection go?
The most recent inspection on record closed on 11 December 2019 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Coral Drugs manufacture?
2 registered sites are on record, in India (India and Sonipat). Every site is listed on this page with the register it came from.
What does Coral Drugs make?
10 molecules are on record against Coral Drugs, including Budesonide, Mometasone Furoate, Fluticasone Furoate and Fluticasone Propionate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Coral Drugs's GMP?
Current GMP certificates are on record from EDQM and EMA. 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 VAI, on 11 December 2019.

Comparable suppliers

Cipla shares 5 molecules Farmabios shares 5 molecules Sterling shares 5 molecules Newchem shares 5 molecules Curia shares 4 molecules

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