Suppliers / Arch Pharmalabs

Arch Pharmalabs

India 674 employees Updated 9 July 2026

Arch Pharmalabs is an API manufacturer based in India. It holds 12 active US drug master files across a filed portfolio of 14 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 12 September 2025 as VAI. Customs aggregates show $17K of exports covering 6 molecules to 2 destinations in 2025.

12
active US DMFs
0
valid CEPs
2
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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 12 September 2025 VAI US FDA
  • 25 May 2018 VAI US FDA
  • 29 January 2016 VAI US FDA
  • 3 May 2013 VAI US FDA
  • 5 December 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
Thane, India 3002808114
Sangareddy District, India 3007556480

What they file, and where

Molecule Regulators Docs
Gemcitabine US FDA 2
Meloxicam SFDA (Saudi Arabia), US FDA 2
Piroxicam SFDA (Saudi Arabia), US FDA 2
Amlodipine US FDA 1
Atorvastatin US FDA 1
Benzatropine US FDA 1
Citalopram US FDA 1
Clopidogrel US FDA 1
Diclofenac SFDA (Saudi Arabia) 1
Dicofenac SFDA (Saudi Arabia) 1
Show all 14 molecules on file
Docetaxel SFDA (Saudi Arabia) 1
Escitalopram US FDA 1
Irinotecan US FDA 1
Ursodeoxycholic Acid US FDA 1

Also appears on these molecule pages

Amlodipine API Benzatropine API Citalopram API Diclofenac API Escitalopram API Gemcitabine API Irinotecan API Meloxicam API Piroxicam API Ursodeoxycholic Acid API Atorvastatin API Clopidogrel API
Show 1 more molecule pages
Docetaxel API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Scale

Year Revenue Exports Destinations
2025 Not reported $17K 2
2024 Not reported $680K 11
2023 Not reported $2.7M 27
2022 Not reported $1.3M 21

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 We do not publish the identity of any buyer.

Questions about Arch Pharmalabs

Does Arch Pharmalabs hold a US DMF or a CEP?
Arch Pharmalabs holds 12 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 Arch Pharmalabs FDA-registered?
2 sites operated by Arch Pharmalabs 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 Arch Pharmalabs's last inspection go?
The most recent inspection on record closed on 12 September 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Arch Pharmalabs manufacture?
2 registered sites are on record, in India (Thane and Sangareddy District). Every site is listed on this page with the register it came from.
What does Arch Pharmalabs make?
14 molecules are on record against Arch Pharmalabs, including Gemcitabine, Meloxicam, Piroxicam and Amlodipine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Arch Pharmalabs's GMP?
Current GMP certificates are on record from US FDA. 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 12 September 2025.

Comparable suppliers

Hetero shares 6 molecules Cipla shares 5 molecules Dr Reddy's Laboratories shares 5 molecules Apitoria Pharma shares 4 molecules Olon shares 4 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
Customs aggregates
Export values, molecule and destination counts