Suppliers / Aragen Life Sciences

Aragen Life Sciences

India Updated 9 July 2026

Aragen Life Sciences is an API manufacturer based in India. It holds 3 active US drug master files across a filed portfolio of 4 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 14 May 2025 as NAI. Customs aggregates show $18.8M of exports covering 4,745 molecules to 49 destinations in 2025.

3
active US DMFs
0
valid CEPs
3
registered plants 3 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 May 2025 NAI US FDA
  • 21 March 2025 VAI US FDA
  • 3 May 2019 NAI US FDA
  • 4 May 2018 VAI US FDA
  • 13 August 2015 VAI US FDA

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

Registered plants

Site FDA FEI
Medchal Malkajgiri, India 3011573185
Hyderabad, India 3005851210
Anakapali District, India 3014738606

What they file, and where

Molecule Regulators Docs
Dobutamine US FDA 1
Moxifloxacin SFDA (Saudi Arabia) 1
Pentosan Polysulfate Sodium US FDA 1
Tramadol US FDA 1

Also appears on these molecule pages

Dobutamine API Moxifloxacin API Pentosan Polysulfate API Tramadol API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
US FDA None 2

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $9.9M 35
2025 Not reported $18.8M 49

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 We do not publish the identity of any buyer.

Questions about Aragen Life Sciences

Does Aragen Life Sciences hold a US DMF or a CEP?
Aragen Life Sciences holds 3 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 Aragen Life Sciences FDA-registered?
3 sites operated by Aragen Life Sciences 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 Aragen Life Sciences's last inspection go?
The most recent inspection on record closed on 14 May 2025 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.
Where does Aragen Life Sciences manufacture?
3 registered sites are on record, in India (Medchal Malkajgiri, Hyderabad and Anakapali District). Every site is listed on this page with the register it came from.
What does Aragen Life Sciences make?
4 molecules are on record against Aragen Life Sciences, including Dobutamine, Moxifloxacin, Pentosan Polysulfate Sodium and Tramadol. Each links through to that molecule's full manufacturer list.
Which regulators recognise Aragen Life Sciences'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 NAI, on 14 May 2025.

Comparable suppliers

Apitoria Pharma shares 2 molecules Dr Reddy's Laboratories shares 2 molecules Macleods Pharmaceuticals shares 2 molecules Micro Labs shares 2 molecules Hetero 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