Suppliers / Arene Life Sciences

Arene Life Sciences

India 222 employees Updated 9 July 2026

Arene Life Sciences is an API manufacturer based in India. It holds 31 active US drug master files across a filed portfolio of 16 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 30 August 2024 as VAI. Customs aggregates show $7.0M of exports covering 140 molecules to 29 destinations in 2025.

31
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
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 30 August 2024 VAI US FDA

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

Registered plants

Site FDA FEI
Nalgonda, India 3033870708
Sangareddy, India 3013438177

What they file, and where

Molecule Regulators Docs
Dolutegravir SFDA (Saudi Arabia), US FDA 3
Amlodipine US FDA 2
Bictegravir US FDA 2
Clopidogrel US FDA 2
Darunavir US FDA 2
Efavirenz US FDA 2
Emtricitabine US FDA 2
Lamivudine US FDA 2
Lopinavir US FDA 2
Nefopam US FDA 2
Show all 16 molecules on file
Oxcarbazepine US FDA 2
Ritonavir US FDA 2
Tedizolid US FDA 2
Tenofovir Alafenamide US FDA 2
Trazodone US FDA 2
Eslicarbazepine Acetate US FDA 1

Also appears on these molecule pages

Abacavir contract manufacturing Acyclovir contract manufacturing Amlodipine contract manufacturing Atazanavir contract manufacturing Bictegravir contract manufacturing Calci contract manufacturing Clopidogrel contract manufacturing Darunavir contract manufacturing Dolutegravir contract manufacturing Efavirenz contract manufacturing Emtricitabine contract manufacturing Eslicarbazepine API
Show 16 more molecule pages
Ganciclovir contract manufacturing Lamivudine API Lopinavir contract manufacturing Nefopam API Nevirapine contract manufacturing Oseltamivir contract manufacturing Oxcarbazepine API Raltegravir contract manufacturing Rilpivirine contract manufacturing Ritonavir contract manufacturing Tapentadol contract manufacturing Tedizolid API Tenofovir Alafenamide API Trazodone API Valganciclovir contract manufacturing Zidovudine contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $4.3M 17
2025 Not reported $7.0M 29

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 We do not publish the identity of any buyer.

Questions about Arene Life Sciences

Does Arene Life Sciences hold a US DMF or a CEP?
Arene Life Sciences holds 31 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 Arene Life Sciences FDA-registered?
2 sites operated by Arene 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 Arene Life Sciences's last inspection go?
The most recent inspection on record closed on 30 August 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Arene Life Sciences manufacture?
2 registered sites are on record, in India (Nalgonda and Sangareddy). Every site is listed on this page with the register it came from.
What does Arene Life Sciences make?
16 molecules are on record against Arene Life Sciences, including Dolutegravir, Amlodipine, Bictegravir and Clopidogrel. Each links through to that molecule's full manufacturer list.
Which regulators recognise Arene 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 VAI, on 30 August 2024.

Comparable suppliers

Matrix Pharmacorp shares 10 molecules Apitoria Pharma shares 9 molecules Hetero shares 9 molecules Cipla shares 9 molecules Laurus Labs shares 9 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