Suppliers / Virupaksha Organics

Virupaksha Organics

India Updated 9 July 2026

Virupaksha Organics is an API and finished-dose manufacturer based in India. It holds 18 active US drug master files and 6 valid CEPs across a filed portfolio of 11 molecules. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 7 February 2025 as VAI. Customs aggregates show $15.6M of exports covering 280 molecules to 55 destinations in 2025.

18
active US DMFs
6
valid CEPs
3
registered plants 2 with an FDA FEI number
4
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 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

  • 7 February 2025 VAI US FDA
  • 16 November 2018 VAI US FDA
  • 29 January 2016 VAI US FDA
  • 26 September 2013 NAI 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 3018360272
Sangareddy, India 3008154209
Gaddipotharam, India Not on file

What they file, and where

Molecule Regulators Docs
Citalopram EDQM, US FDA 3
Escitalopram EDQM, US FDA 3
Fexofenadine SFDA (Saudi Arabia), US FDA 3
Fluconazole EDQM, US FDA 3
Tramadol EDQM, US FDA 3
Bilastine US FDA 2
Crisaborole US FDA 2
Dextromethorphan US FDA 2
Efinaconazole US FDA 2
Fexofenadine Hydrochloride EDQM 1
Show all 11 molecules on file
Tapentadol EDQM 1

Also appears on these molecule pages

Bempedoic Acid finished dose Bilastine API Citalopram API Crisaborole API Dextromethorphan API Efinaconazole API Escitalopram API Fexofenadine API Fluconazole API Tapentadol API Tramadol API Vonoprazan finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 4 None
US FDA None 1
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $3.4M 25
2025 Not reported $15.6M 55
2024 Not reported $19.1M 53
2023 Not reported $31.6M 45

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 We do not publish the identity of any buyer.

Questions about Virupaksha Organics

Does Virupaksha Organics hold a US DMF or a CEP?
Virupaksha Organics holds 18 active US drug master files and 6 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 Virupaksha Organics FDA-registered?
2 sites operated by Virupaksha Organics 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 Virupaksha Organics's last inspection go?
The most recent inspection on record closed on 7 February 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Virupaksha Organics manufacture?
3 registered sites are on record, in India (Hyderabad, Sangareddy and Gaddipotharam). Every site is listed on this page with the register it came from.
What does Virupaksha Organics make?
11 molecules are on record against Virupaksha Organics, including Citalopram, Escitalopram, Fexofenadine and Fluconazole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Virupaksha Organics'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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 7 February 2025.

Comparable suppliers

Apitoria Pharma shares 6 molecules Cipla shares 4 molecules Dr Reddy's Laboratories shares 4 molecules Matrix Pharmacorp shares 4 molecules Macleods Pharmaceuticals shares 4 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