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
Gidc, India Not on file
naroda ahmedabad 382 330 ahmedabad, 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

Questions about Halcyon Labs

Does Halcyon Labs hold a US DMF or a CEP?
Halcyon Labs holds 4 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 Halcyon Labs FDA-registered?
One site operated by Halcyon 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 Halcyon Labs's last inspection go?
The most recent inspection on record closed on 18 February 2015 as NAI (No Action Indicated: nothing objectionable was found). 2 inspections are on file.
Where does Halcyon Labs manufacture?
4 registered sites are on record, in India (Gidc, Naroda Ahmedabad 382 330 Ahmedabad and Mumbai among others). Every site is listed on this page with the register it came from.
What does Halcyon Labs make?
4 molecules are on record against Halcyon Labs, including Betamethasone, Mometasone Furoate, Clobetasol Propionate and Clotrimazole. Each links through to that molecule's full manufacturer list.
Which regulators recognise Halcyon Labs's GMP?
Current GMP certificates are on record from CDSCO (India). 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 NAI, on 18 February 2015.

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Curia shares 3 molecules Farmabios shares 3 molecules Symbiotec Pharmalab shares 3 molecules Avik Pharmaceutical shares 3 molecules Symbiotica Speciality Ingredients Sdn.Bhd shares 3 molecules

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