Suppliers / Virchow Laboratories

Virchow Laboratories

India 3 duplicate records merged Updated 9 July 2026

Virchow Laboratories is an API manufacturer based in India. It holds one active US drug master file and one valid CEP. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 6 June 2024 as VAI. Customs aggregates show $22.0M of exports covering 435 molecules to 49 destinations in 2025.

1
active US DMFs
1
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 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

  • 6 June 2024 VAI US FDA
  • 11 December 2015 VAI US FDA
  • 16 October 2012 VAI US FDA
  • 6 November 2008 VAI US FDA

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

Registered plants

Site FDA FEI
Ida Jeedimetla Hyderabad, India 3003649250
Hyderabad, India Not on file

What they file, and where

Molecule Regulators Docs
Sulfamethoxazole EDQM, US FDA 2

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $4.5M 29
2025 Not reported $22.0M 49
2024 Not reported $20.4M 54
2023 Not reported $34.1M 53

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 We do not publish the identity of any buyer.

Questions about Virchow Laboratories

Does Virchow Laboratories hold a US DMF or a CEP?
Virchow Laboratories holds 1 active US drug master file and 1 valid CEP. 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 Virchow Laboratories FDA-registered?
One site operated by Virchow Laboratories 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 Virchow Laboratories's last inspection go?
The most recent inspection on record closed on 6 June 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Virchow Laboratories manufacture?
2 registered sites are on record, in India (Ida Jeedimetla Hyderabad and Hyderabad). Every site is listed on this page with the register it came from.
What does Virchow Laboratories make?
1 molecule is on record against Virchow Laboratories, including Sulfamethoxazole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Virchow Laboratories's GMP?
Current GMP certificates are on record from 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 6 June 2024.

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