Suppliers / Aurobindo Pharma

Aurobindo Pharma

India AUROPHARMA.BO 4 duplicate records merged Updated 9 July 2026

Aurobindo Pharma is an API and finished-dose manufacturer based in India. It appears in 1,315 regulatory filings across 21 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA, NMRC (NA) and DAV (Vietnam). Its GMP standing is certified by EMA, EAEU_EEC and US FDA, among 7 authorities. Its most recent recorded inspection, by US FDA, closed on 14 November 2025 as OAI. Customs aggregates show $265K of exports covering 18 molecules to 6 destinations in 2025.

0
active US DMFs
0
valid CEPs
12
registered plants 7 with an FDA FEI number
1,315
filings across 21 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
7 of 7 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

  • 14 November 2025 OAI US FDA
  • 5 September 2025 OAI US FDA
  • 3 May 2024 OAI US FDA
  • 2 February 2024 OAI US FDA
  • 29 September 2023 VAI US FDA
  • 26 July 2023 NAI US FDA
  • 21 July 2023 VAI US FDA
  • 9 March 2023 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 Not on file
MEDAK DISTRICT, India Not on file
Anakapalli, India Not on file
Srikakulam, India Not on file
Medchal, India 3004021229
Sangareddy, India 3004021263

6 further sites are on record.

What they file, and where

Molecule Regulators Docs
Alendronic Acid SFDA (Saudi Arabia) 1
Alfuzosin SFDA (Saudi Arabia) 1
Atomoxetine SFDA (Saudi Arabia) 1
Clopidogrel SFDA (Saudi Arabia) 1
Eletriptan SFDA (Saudi Arabia) 1
Finasteride SFDA (Saudi Arabia) 1
Mirtazapine SFDA (Saudi Arabia) 1
Rosuvastatin SFDA (Saudi Arabia) 1
Sitagliptin SFDA (Saudi Arabia) 1
Tadalafil SFDA (Saudi Arabia) 1
Show all 11 molecules on file
Valganciclovir SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Abacavir finished dose Alendronic Acid API Alfuzosin API Aminocaproic Acid finished dose Amisulpride finished dose Amoxicillin finished dose Armodafinil finished dose Atazanavir finished dose Atomoxetine API Baricitinib finished dose Bezafibrate finished dose Bisoprolol finished dose
Show 71 more molecule pages
Cephalexin finished dose Cevimeline finished dose Chlordiazepoxide finished dose Chlorpromazine finished dose Clomipramine finished dose Colchicine finished dose Dabigatran Etexilate finished dose Dalfampridine finished dose Dapsone finished dose Darifenacin finished dose Darunavir finished dose Deflazacort finished dose Dofetilide finished dose Doxepin finished dose Droxidopa finished dose Dutasteride finished dose Econazole finished dose Efavirenz finished dose Eletriptan API Ertapenem finished dose Everolimus finished dose Famciclovir finished dose Fesoterodine finished dose Finasteride API Galantamine finished dose Glycerol Phenylbutyrate finished dose Guanfacine finished dose Hydroxychloroquine finished dose Lamivudine finished dose Levosalbutamol finished dose Lifitegrast finished dose Lisinopril finished dose Lopinavir finished dose Lurasidone finished dose Meloxicam finished dose Midodrine finished dose Minocycline finished dose Mirtazapine API Montelukast finished dose Mycophenolic Acid finished dose Nadolol finished dose Nevirapine finished dose Paricalcitol finished dose Pazopanib finished dose Perindopril Tert-Butylamine finished dose Permethrin finished dose Pitavastatin finished dose Posaconazole finished dose Propafenone finished dose Ribavirin finished dose Risedronic Acid finished dose Roflumilast finished dose Rufinamide finished dose Sertraline finished dose Sevelamer finished dose Simvastatin finished dose Sotalol finished dose Telmisartan finished dose Tenofovir Disoproxil finished dose Terbinafine finished dose Tizanidine finished dose Torasemide finished dose Valganciclovir API Vigabatrin finished dose Zidovudine finished dose Ziprasidone finished dose Zonisamide finished dose Rosuvastatin API Clopidogrel API Sitagliptin API Tadalafil API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 630 3
NMRC (NA) 143 None
DAV (Vietnam) 137 None
TMDA (TZ) 115 None
EFDA (ET) 98 None
DH (HK) 39 None
EMA None 14
EAEU_EEC None 3
ANVISA (Brazil) None 2
NAFDAC (NG) None 2
FDA (GH) None 1
MHRA (UK) None 1

Scale

Year Revenue Exports Destinations
2025 $3.7B $265K 6
2024 $3.5B Not reported Not reported
2023 $3.0B Not reported Not reported

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

Questions about Aurobindo Pharma

Does Aurobindo Pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Aurobindo Pharma. It does have 1,315 filings with 21 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Aurobindo Pharma FDA-registered?
7 sites operated by Aurobindo Pharma 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 Aurobindo Pharma's last inspection go?
The most recent inspection on record closed on 14 November 2025 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 8 inspections are on file, of which 4 closed as OAI.
Where does Aurobindo Pharma manufacture?
12 registered sites are on record, in India (Hyderabad, Medak District and Anakapalli among others). Every site is listed on this page with the register it came from.
What does Aurobindo Pharma make?
11 molecules are on record against Aurobindo Pharma, including Alendronic Acid, Alfuzosin, Atomoxetine and Clopidogrel. Each links through to that molecule's full manufacturer list.
Which regulators recognise Aurobindo Pharma's GMP?
Current GMP certificates are on record from EMA, EEC (Eurasian Economic Union), US FDA, ANVISA (Brazil), NAFDAC (NG) 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 OAI, on 14 November 2025.

Comparable suppliers

Apitoria Pharma shares 7 molecules Hetero shares 6 molecules Matrix Pharmacorp shares 5 molecules Dr Reddy's Laboratories shares 4 molecules Cipla shares 3 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
Company filings
Revenue as reported