Suppliers / USV

USV

India 3 duplicate records merged Updated 9 July 2026

USV is an API and finished-dose manufacturer based in India. It holds 30 active US drug master files and 14 valid CEPs. Its filings concentrate with DAV (Vietnam), CDSCO (India) and ZAMRA (ZM). Its GMP standing is certified by EMA, MHRA (UK) and CDSCO (India), among 6 authorities. Its most recent recorded inspection, by US FDA, closed on 12 September 2025 as VAI. Customs aggregates show $17.3M of exports covering 334 molecules to 50 destinations in 2025.

30
active US DMFs
14
valid CEPs
9
registered plants 3 with an FDA FEI number
39
filings across 9 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 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

  • 12 September 2025 VAI US FDA
  • 17 November 2022 OAI US FDA
  • 7 February 2020 NAI US FDA
  • 4 August 2017 VAI US FDA
  • 2 August 2017 VAI US FDA
  • 10 June 2016 OAI US FDA
  • 14 August 2015 VAI US FDA
  • 27 March 2015 VAI US FDA

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

Registered plants

Site FDA FEI
NAVI MUMBAI, India Not on file
HIMACHAL PRADESH, India Not on file
Mumbai, India Not on file
DAMAN, India Not on file
Vadodara, India 3027308441
Dabhel, India 3004086192

3 further sites are on record.

What they file, and where

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 11 None
CDSCO (India) 10 2
ZAMRA (ZM) 5 None
ARCSA (EC) 3 None
US FDA 3 1
INFARMED (PT) 3 None
EMA None 8
MHRA (UK) None 4
ANVISA (Brazil) None 1
TMDA (TZ) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $12.7M 35
2025 Not reported $17.3M 50
2024 Not reported $16.9M 30
2023 Not reported $13.6M 30

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 We do not publish the identity of any buyer.

Questions about USV

Does USV hold a US DMF or a CEP?
USV holds 30 active US drug master files and 14 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 USV FDA-registered?
3 sites operated by USV 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 USV's last inspection go?
The most recent inspection on record closed on 12 September 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 2 closed as OAI.
Where does USV manufacture?
9 registered sites are on record, in India (Navi Mumbai, Himachal Pradesh and Mumbai among others). Every site is listed on this page with the register it came from.
What does USV make?
30 molecules are on record against USV, including Metformin, Acitretin, Glimepiride and Pioglitazone. Each links through to that molecule's full manufacturer list.
Which regulators recognise USV's GMP?
Current GMP certificates are on record from EMA, MHRA (UK), CDSCO (India), ANVISA (Brazil), TMDA (TZ) and 1 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

  • 11 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 12 September 2025.

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