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

Show 1 more 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 We do not publish the identity of any buyer.

Questions about Calyx Chemicals and Pharmaceuticals

Does Calyx Chemicals and Pharmaceuticals hold a US DMF or a CEP?
Calyx Chemicals and Pharmaceuticals holds 18 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 Calyx Chemicals and Pharmaceuticals FDA-registered?
One site operated by Calyx Chemicals and Pharmaceuticals 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 Calyx Chemicals and Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 17 May 2024 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 5 inspections are on file, of which 1 closed as OAI.
Where does Calyx Chemicals and Pharmaceuticals manufacture?
2 registered sites are on record, in India (District Palghar and Palghar). Every site is listed on this page with the register it came from.
What does Calyx Chemicals and Pharmaceuticals make?
15 molecules are on record against Calyx Chemicals and Pharmaceuticals, including Erythromycin, Azithromycin, Isoniazid and Artemether. Each links through to that molecule's full manufacturer list.
Which regulators recognise Calyx Chemicals and Pharmaceuticals's GMP?
Current GMP certificates are on record from EMA. 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 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