Suppliers / Nifty Labs

Nifty Labs

India 126 employees Updated 9 July 2026

Nifty Labs is an API manufacturer based in India. It holds 8 valid CEPs across a filed portfolio of 8 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 25 September 2025 as VAI.

0
active US DMFs
8
valid CEPs
3
registered plants 1 with an FDA FEI number
1
filings across 1 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

  • 25 September 2025 VAI US FDA
  • 22 February 2019 VAI US FDA
  • 27 October 2016 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 Not on file
NTR, India Not on file
Ntr Dist, India 3007025492

What they file, and where

Molecule Regulators Docs
Esomeprazole EDQM, SFDA (Saudi Arabia) 2
Aripiprazole EDQM 1
Doxazosin Mesilate EDQM 1
Lansoprazole EDQM 1
Quetiapine EDQM 1
Quetiapine Fumarate EDQM 1
Rabeprazole EDQM 1
Rivaroxaban EDQM 1

Also appears on these molecule pages

Apixaban contract manufacturing Aripiprazole contract manufacturing Cariprazine contract manufacturing Cilostazol contract manufacturing Diltiazem contract manufacturing Dimethyl contract manufacturing Domperidone contract manufacturing Doxazosin contract manufacturing Doxazosin Mesilate API Duloxetine contract manufacturing Esomeprazole contract manufacturing Itraconazole contract manufacturing
Show 8 more molecule pages
Ivabradine contract manufacturing Ketoprofen contract manufacturing Lansoprazole contract manufacturing Olanzapine contract manufacturing Omeprazole contract manufacturing Rabeprazole contract manufacturing Quetiapine API Rivaroxaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
EMA None 1
US FDA None 1

Questions about Nifty Labs

Does Nifty Labs hold a US DMF or a CEP?
Nifty Labs holds 8 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 Nifty Labs FDA-registered?
One site operated by Nifty Labs 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 Nifty Labs's last inspection go?
The most recent inspection on record closed on 25 September 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Nifty Labs manufacture?
3 registered sites are on record, in India (Hyderabad, NTR and Ntr Dist). Every site is listed on this page with the register it came from.
What does Nifty Labs make?
8 molecules are on record against Nifty Labs, including Esomeprazole, Aripiprazole, Doxazosin Mesilate and Lansoprazole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Nifty Labs'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 25 September 2025.

Comparable suppliers

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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