Suppliers / Alchem International

Alchem International

India 581 employees Updated 9 July 2026

Alchem International is an API manufacturer based in India. It holds 7 active US drug master files across a filed portfolio of 6 molecules. Its GMP standing is certified by US FDA, CDSCO (India) and NAFDAC (NG). Its most recent recorded inspection, by US FDA, closed on 4 July 2025 as VAI. Customs aggregates show $44.8M of exports covering 497 molecules to 51 destinations in 2025.

7
active US DMFs
0
valid CEPs
4
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 4 July 2025 VAI US FDA
  • 22 July 2024 VAI US FDA
  • 6 September 2019 VAI US FDA
  • 15 September 2017 VAI US FDA
  • 4 August 2016 NAI US FDA
  • 1 April 2016 VAI US FDA
  • 11 July 2012 VAI US FDA
  • 8 October 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Alwar, India 3009344588
Faridabad, India 3003310718
district faridabad 121004, India Not on file
Village, India Not on file

What they file, and where

Molecule Regulators Docs
Scopolamine US FDA 2
Atropine US FDA 1
Colchicine US FDA 1
Digoxin US FDA 1
Methscopolamine Bromide US FDA 1
Nicotine US FDA 1

Also appears on these molecule pages

Atropine API Colchicine API Digoxin API Nicotine API Scopolamine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 2
CDSCO (India) None 2
NAFDAC (NG) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $6.6M 29
2025 Not reported $44.8M 51
2024 Not reported $29.0M 45
2023 Not reported $26.5M 42

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 We do not publish the identity of any buyer.

Questions about Alchem International

Does Alchem International hold a US DMF or a CEP?
Alchem International holds 7 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 Alchem International FDA-registered?
2 sites operated by Alchem International carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Alchem International's last inspection go?
The most recent inspection on record closed on 4 July 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Alchem International manufacture?
4 registered sites are on record, in India (Alwar, Faridabad and District Faridabad 121004 among others). Every site is listed on this page with the register it came from.
What does Alchem International make?
6 molecules are on record against Alchem International, including Scopolamine, Atropine, Colchicine and Digoxin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Alchem International's GMP?
Current GMP certificates are on record from US FDA, CDSCO (India) and NAFDAC (NG). 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 VAI, on 4 July 2025.

Comparable suppliers

India Glycols shares 2 molecules Matrix Pharmacorp shares 1 molecule Solara Active Pharma Sciences shares 1 molecule Honour Lab shares 1 molecule Cambrex Charles City shares 1 molecule

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
Customs aggregates
Export values, molecule and destination counts