Suppliers / Enaltec Labs

Enaltec Labs

India 460 employees Updated 9 July 2026

Enaltec Labs is an API and finished-dose manufacturer based in India. It holds 22 active US drug master files across a filed portfolio of 19 molecules. Its filings concentrate with CDSCO (India) and MINSA (CR). Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 27 March 2025 as VAI.

22
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
9
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 27 March 2025 VAI US FDA
  • 26 July 2019 VAI US FDA
  • 10 November 2015 VAI US FDA
  • 8 August 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
Thane, India 3006599894

What they file, and where

Molecule Regulators Docs
Phylloquinone US FDA 4
Chlorpromazine US FDA 2
Clonidine US FDA 2
Dofetilide US FDA 2
Fluphenazine US FDA 2
Midodrine US FDA 2
Neostigmine US FDA 2
Ramelteon US FDA 2
Trospium US FDA 2
Varenicline US FDA 2
Show all 19 molecules on file
Alcaftadine SFDA (Saudi Arabia) 1
Brimonidine SFDA (Saudi Arabia) 1
Dalfampridine SFDA (Saudi Arabia) 1
Dimethyl SFDA (Saudi Arabia) 1
Montelukast SFDA (Saudi Arabia) 1
Moxifloxacin SFDA (Saudi Arabia) 1
Rosuvastatin SFDA (Saudi Arabia) 1
Strontium Ranelate SFDA (Saudi Arabia) 1
Timolol SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Alcaftadine API Ambrisentan finished dose Bempedoic Acid finished dose Brimonidine API Chlorpromazine API Clonidine API Dalfampridine API Dimethyl API Dofetilide API Fluphenazine API Midodrine API Neostigmine API
Show 10 more molecule pages
Phylloquinone API Ramelteon API Rupatadine finished dose Timolol API Trospium API Varenicline API Vonoprazan finished dose Rosuvastatin API Montelukast API Moxifloxacin API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 5 None
MINSA (CR) 4 None
MFDS (Korea) None 2
US FDA None 1

Questions about Enaltec Labs

Does Enaltec Labs hold a US DMF or a CEP?
Enaltec Labs holds 22 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 Enaltec Labs FDA-registered?
One site operated by Enaltec 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 Enaltec Labs's last inspection go?
The most recent inspection on record closed on 27 March 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Enaltec Labs manufacture?
1 registered site is on record, in India (Thane). Every site is listed on this page with the register it came from.
What does Enaltec Labs make?
19 molecules are on record against Enaltec Labs, including Phylloquinone, Chlorpromazine, Clonidine and Dofetilide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Enaltec Labs's GMP?
Current GMP certificates are on record from MFDS (Korea) 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

  • 1 active litigation matter is on record.
  • The most recent inspection outcome was VAI, on 27 March 2025.

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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