Suppliers / Halcyon Labs

Halcyon Labs

India Updated 9 July 2026

Halcyon Labs is an API manufacturer based in India. It holds 4 active US drug master files across a filed portfolio of 4 molecules. Its GMP standing is certified by CDSCO (India). Its most recent recorded inspection, by US FDA, closed on 18 February 2015 as NAI.

4
active US DMFs
0
valid CEPs
4
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
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 18 February 2015 NAI US FDA
  • 11 May 2011 VAI US FDA

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

Registered plants

Site FDA FEI
naroda ahmedabad 382 330 ahmedabad, India Not on file
Gidc, India Not on file
Mumbai, India 3006033094
narodaahme dabad 382 330ahmedabad, India Not on file

What they file, and where

Molecule Regulators Docs
Betamethasone US FDA 2
Mometasone Furoate SFDA (Saudi Arabia), US FDA 2
Clobetasol Propionate US FDA 1
Clotrimazole SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Betamethasone API Clobetasol API Clotrimazole API Mometasone API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) None 3

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Open risk flags

  • The most recent inspection outcome was NAI, on 18 February 2015.

Sources on this page

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