Suppliers / Valens Molecules

Valens Molecules

India 94 employees Updated 9 July 2026

Valens Molecules is an API manufacturer based in India. It holds 4 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 15 November 2024 as VAI. Customs aggregates show $9.6M of exports covering 82 molecules to 22 destinations in 2025.

4
active US DMFs
0
valid CEPs
3
registered plants 3 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 15 November 2024 VAI US FDA
  • 29 July 2016 VAI US FDA
  • 6 April 2015 OAI US FDA
  • 8 March 2013 OAI US FDA
  • 20 May 2010 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 3001329340
Viskhapatnam, India 3013629262
Medchal, India 3003802255

What they file, and where

Molecule Regulators Docs
Phenazopyridine US FDA 2
Sulfasalazine SFDA (Saudi Arabia), US FDA 2
Hydrochlorothiazide US FDA 1

Also appears on these molecule pages

Hydrochlorothiazide API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.4M 7
2025 Not reported $9.6M 22
2024 Not reported $7.4M 23
2023 Not reported $8.2M 25

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 We do not publish the identity of any buyer.

Questions about Valens Molecules

Does Valens Molecules hold a US DMF or a CEP?
Valens Molecules holds 4 active US drug master files. 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 Valens Molecules FDA-registered?
3 sites operated by Valens Molecules 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 Valens Molecules's last inspection go?
The most recent inspection on record closed on 15 November 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file, of which 2 closed as OAI.
Where does Valens Molecules manufacture?
3 registered sites are on record, in India (Hyderabad, Viskhapatnam and Medchal). Every site is listed on this page with the register it came from.
What does Valens Molecules make?
3 molecules are on record against Valens Molecules, including Phenazopyridine, Sulfasalazine and Hydrochlorothiazide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Valens Molecules's GMP?
Current GMP certificates are on record from US FDA. 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 15 November 2024.

Comparable suppliers

Apitoria Pharma shares 1 molecule Alembic Pharmaceuticals shares 1 molecule Zydus Lifesciences shares 1 molecule Ipca Laboratories shares 1 molecule Macleods Pharmaceuticals shares 1 molecule

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