Suppliers / Aurore pharmaceuticals

Aurore pharmaceuticals

India Updated 9 July 2026

Aurore pharmaceuticals is an API and finished-dose manufacturer based in India. It appears in 141 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), PPB (KE) and UZPHARM (UZ). Its GMP standing is certified by EAEU_EEC, MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 31 May 2024 as VAI. Customs aggregates show $603K of exports covering 17 molecules to 7 destinations in 2025.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
141
filings across 9 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

  • 31 May 2024 VAI US FDA
  • 25 May 2018 NAI US FDA
  • 7 February 2014 NAI US FDA
  • 29 October 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
Hyderabad, India 3003937580

What they file, and where

Molecule Regulators Docs
Celecoxib SFDA (Saudi Arabia) 1
Tolvaptan SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 36 None
PPB (KE) 26 None
UZPHARM (UZ) 25 None
MINSA (CR) 18 None
INVIMA (CO) 14 None
RCETH (BY) 10 None
EAEU_EEC None 7
MFDS (Korea) None 2
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $30K 3
2025 Not reported $603K 7
2024 Not reported $359K 6
2023 Not reported $1.6M 10

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 We do not publish the identity of any buyer.

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Open risk flags

  • The most recent inspection outcome was VAI, on 31 May 2024.

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