Suppliers / Valary Lab

Valary Lab

India Updated 9 July 2026

Valary Lab is an API manufacturer based in India. It holds 50 active US drug master files across a filed portfolio of 17 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 13 September 2024 as VAI.

50
active US DMFs
0
valid CEPs
1
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
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 13 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
Anakapalli District, India 3019200343

What they file, and where

Molecule Regulators Docs
Belzutifan US FDA 3
Binimetinib US FDA 3
Cabozantinib US FDA 3
Desogestrel US FDA 3
Encorafenib US FDA 3
Ethinylestradiol US FDA 3
Lenalidomide US FDA 3
Levonorgestrel US FDA 3
Levothyroxine US FDA 3
Liothyronine Sodium US FDA 3
Show all 17 molecules on file
Niraparib US FDA 3
Pralsetinib US FDA 3
Ribociclib US FDA 3
Ruxolitinib US FDA 3
Tivozanib US FDA 3
Trametinib US FDA 3
Dabrafenib US FDA 2

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Valary Lab

Does Valary Lab hold a US DMF or a CEP?
Valary Lab holds 50 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 Valary Lab FDA-registered?
One site operated by Valary Lab 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 Valary Lab's last inspection go?
The most recent inspection on record closed on 13 September 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Valary Lab manufacture?
1 registered site is on record, in India (Anakapalli District). Every site is listed on this page with the register it came from.
What does Valary Lab make?
17 molecules are on record against Valary Lab, including Belzutifan, Binimetinib, Cabozantinib and Desogestrel. Each links through to that molecule's full manufacturer list.
Which regulators recognise Valary Lab'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 13 September 2024.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates