Suppliers / Aurore Life Sciences

Aurore Life Sciences

India 361 employees reconciled across 9 public records · 3 entities Updated 9 July 2026

Aurore Life Sciences is an API manufacturer based in India. It holds 35 active US drug master files and 27 valid CEPs. Its filings concentrate with ARCSA (EC), PPB (KE) and UZPHARM (UZ). Its GMP standing is certified by EAEU_EEC, MFDS (Korea) and EMA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 31 May 2024 as VAI. Customs aggregates show $10.3M of exports covering 143 molecules to 34 destinations in 2025.

35
active US DMFs
27
valid CEPs
4
registered plants 2 with an FDA FEI number
144
filings across 9 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Sources: FDA Establishment Registration, 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
Sangareddy, India 3018005839
Hyderabad, India Not on file
Hyderabad, India 3003937580
Hyderabad, India Not on file

What they file, and where

Molecule Regulators Docs
Celecoxib EDQM, SFDA (Saudi Arabia), US FDA 4
Levetiracetam EDQM, US FDA 4
Clozapine EDQM, US FDA 3
Tolvaptan SFDA (Saudi Arabia), US FDA 3
Valaciclovir EDQM, US FDA 3
Aciclovir EDQM 2
Acyclovir US FDA 2
Amlodipine EDQM, US FDA 2
Dronedarone EDQM, US FDA 2
Favipiravir US FDA 2
Show all 39 molecules on file
Levothyroxine EDQM, US FDA 2
Losartan EDQM, US FDA 2
Oxcarbazepine EDQM, US FDA 2
Raloxifene EDQM, US FDA 2
Tafamidis US FDA 2
Valaciclovir Hydrochloride Hydrate EDQM 2
Valganciclovir EDQM, US FDA 2
Verapamil EDQM, US FDA 2
Amlodipine Besilate EDQM 1
Bilastine US FDA 1
Dabigatran US FDA 1
Dabigatran Etexilate Mesilate EDQM 1
Desvenlafaxine US FDA 1
Fesoterodine US FDA 1
Flecainide EDQM 1
Fluphenazine US FDA 1
Indomethacin US FDA 1
Levothyroxine Sodium EDQM 1
Marbofloxacin US FDA 1
Marbofloxacin For Veterinary Use EDQM 1
Molnupiravir US FDA 1
Nafamostat US FDA 1
Prazosin US FDA 1
Raltegravir Potassium EDQM 1
Risperidone EDQM 1
Salsalate US FDA 1
Sodium Cromoglicate EDQM 1
Sulindac US FDA 1
Tofacitinib US FDA 1

Also appears on these molecule pages

Show 21 more 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
EMA None 1
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $6.2M 25
2025 Not reported $10.3M 34

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 We do not publish the identity of any buyer.

Questions about Aurore Life Sciences

Does Aurore Life Sciences hold a US DMF or a CEP?
Aurore Life Sciences holds 35 active US drug master files and 27 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 Aurore Life Sciences FDA-registered?
2 sites operated by Aurore Life Sciences 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 Aurore Life Sciences'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 Life Sciences manufacture?
4 registered sites are on record, in India (Sangareddy and Hyderabad among others). Every site is listed on this page with the register it came from.
What does Aurore Life Sciences make?
39 molecules are on record against Aurore Life Sciences, including Celecoxib, Levetiracetam, Clozapine and Tolvaptan. Each links through to that molecule's full manufacturer list.
Which regulators recognise Aurore Life Sciences's GMP?
Current GMP certificates are on record from EEC (Eurasian Economic Union), MFDS (Korea), EMA 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