Suppliers / Innovare Labs

Innovare Labs

India 131 employees Updated 9 July 2026

Innovare Labs is an API and finished-dose manufacturer based in India. It holds 15 active US drug master files and 9 valid CEPs across a filed portfolio of 16 molecules. Its GMP standing is certified by COFEPRIS (MX), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 19 September 2024 as VAI.

15
active US DMFs
9
valid CEPs
3
registered plants 1 with an FDA FEI number
2
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 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

  • 19 September 2024 VAI US FDA

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

Registered plants

Site FDA FEI
Visakhapatnam, India 3015709928
Álvaro Obregón, Mexico Not on file
Benito Juárez, Mexico Not on file

What they file, and where

Molecule Regulators Docs
Clopidogrel EDQM, US FDA 2
Levetiracetam EDQM, US FDA 2
Moxifloxacin EDQM, US FDA 2
Oseltamivir EDQM, US FDA 2
Pregabalin EDQM, US FDA 2
Rivaroxaban EDQM, US FDA 2
Rosuvastatin EDQM, US FDA 2
Voriconazole EDQM, US FDA 2
Cinacalcet US FDA 1
Darunavir US FDA 1
Show all 16 molecules on file
Metaxalone US FDA 1
Oseltamivir Phosphate EDQM 1
Ranolazine US FDA 1
Tenofovir Disoproxil US FDA 1
Ticagrelor US FDA 1
Vildagliptin US FDA 1

Also appears on these molecule pages

Cinacalcet API Clopidogrel API Darunavir API Favipiravir finished dose Levetiracetam API Metaxalone API Molnupiravir finished dose Moxifloxacin API Oseltamivir API Pregabalin API Ranolazine API Rivaroxaban API
Show 5 more molecule pages
Rosuvastatin API Tenofovir Disoproxil API Vildagliptin API Voriconazole API Ticagrelor API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 2 None
COFEPRIS (MX) None 2
US FDA None 1
EMA None 1

Questions about Innovare Labs

Does Innovare Labs hold a US DMF or a CEP?
Innovare Labs holds 15 active US drug master files and 9 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 Innovare Labs FDA-registered?
One site operated by Innovare Labs 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 Innovare Labs's last inspection go?
The most recent inspection on record closed on 19 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Innovare Labs manufacture?
3 registered sites are on record, in India and Mexico (Visakhapatnam, Álvaro Obregón and Benito Juárez). Every site is listed on this page with the register it came from.
What does Innovare Labs make?
16 molecules are on record against Innovare Labs, including Clopidogrel, Levetiracetam, Moxifloxacin and Oseltamivir. Each links through to that molecule's full manufacturer list.
Which regulators recognise Innovare Labs's GMP?
Current GMP certificates are on record from COFEPRIS (MX), US FDA 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 19 September 2024.

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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