Suppliers / Aurore pharmaceuticals

Aurore pharmaceuticals

India Updated 9 July 2026

The public registers hold a second record for Aurore pharmaceuticals. The fuller profile, with 35 active US DMFs and 27 valid CEPs, is at Aurore Life Sciences. Figures on this page cover only this record.

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

Dolutegravir finished dose Favipiravir finished dose Lamivudine finished dose Lopinavir finished dose Molnupiravir finished dose Sofosbuvir finished dose Tolvaptan API Celecoxib API

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 We do not publish the identity of any buyer.

Questions about Aurore pharmaceuticals

Does Aurore pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Aurore pharmaceuticals. It does have 141 filings with 9 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Aurore pharmaceuticals FDA-registered?
One site operated by Aurore pharmaceuticals 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 Aurore pharmaceuticals's last inspection go?
The most recent inspection on record closed on 31 May 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Aurore pharmaceuticals manufacture?
1 registered site is on record, in India (Hyderabad). Every site is listed on this page with the register it came from.
What does Aurore pharmaceuticals make?
2 molecules are on record against Aurore pharmaceuticals, including Celecoxib and Tolvaptan. Each links through to that molecule's full manufacturer list.
Which regulators recognise Aurore pharmaceuticals's GMP?
Current GMP certificates are on record from EEC (Eurasian Economic Union), MFDS (Korea) and US FDA. 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 31 May 2024.

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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