Suppliers / Dasami Lab

Dasami Lab

India Updated 9 July 2026

Dasami Lab is an API manufacturer based in India. It holds 64 active US drug master files across a filed portfolio of 27 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 30 May 2025 as VAI.

64
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
3 of 3 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

  • 30 May 2025 VAI US FDA
  • 19 October 2019 VAI US FDA
  • 1 June 2018 VAI US FDA

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

Registered plants

Site FDA FEI
Nalgonda, India 3012753303

What they file, and where

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 2
US FDA None 1

Questions about Dasami Lab

Does Dasami Lab hold a US DMF or a CEP?
Dasami Lab holds 64 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 Dasami Lab FDA-registered?
One site operated by Dasami 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 Dasami Lab's last inspection go?
The most recent inspection on record closed on 30 May 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Dasami Lab manufacture?
1 registered site is on record, in India (Nalgonda). Every site is listed on this page with the register it came from.
What does Dasami Lab make?
27 molecules are on record against Dasami Lab, including Canagliflozin, Dextromethorphan, Droxidopa and Eslicarbazepine Acetate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Dasami Lab's GMP?
Current GMP certificates are on record from EMA and 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 30 May 2025.

Sources on this page

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