Suppliers / Calyx Chemicals and Pharmaceuticals

Calyx Chemicals and Pharmaceuticals

India 314 employees 2 duplicate records merged Updated 9 July 2026

Calyx Chemicals and Pharmaceuticals is an API manufacturer based in India. It holds 18 active US drug master files across a filed portfolio of 15 molecules. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 17 May 2024 as OAI. Customs aggregates show $3.7M of exports covering 72 molecules to 24 destinations in 2025.

18
active US DMFs
0
valid CEPs
2
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
5 of 5 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

  • 17 May 2024 OAI US FDA
  • 8 November 2019 VAI US FDA
  • 4 March 2016 VAI US FDA
  • 27 March 2012 VAI US FDA
  • 18 September 2009 VAI US FDA

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

Registered plants

Site FDA FEI
District Palghar, India 3003721861
Palghar, India Not on file

What they file, and where

Molecule Regulators Docs
Erythromycin US FDA 3
Azithromycin US FDA 2
Isoniazid SFDA (Saudi Arabia), US FDA 2
Artemether US FDA 1
Cetirizine US FDA 1
Eszopiclone US FDA 1
Flucytosine US FDA 1
Hydroxyzine US FDA 1
Irbesartan US FDA 1
Losartan US FDA 1
Show all 15 molecules on file
Lumefantrine US FDA 1
Meclizine US FDA 1
Pyrazinamide US FDA 1
Valganciclovir US FDA 1
Zopiclone US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

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

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $1.1M 8
2025 Not reported $3.7M 24
2024 Not reported $2.7M 24
2023 Not reported $2.0M 18

Export figures are customs aggregates. We do not publish the identity of any buyer.

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Open risk flags

  • The most recent inspection outcome was OAI, on 17 May 2024.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts