Suppliers / Atul Bioscience

Atul Bioscience

India Updated 9 July 2026

Atul Bioscience is an API manufacturer based in India. It holds 8 active US drug master files and 3 valid CEPs across a filed portfolio of 7 molecules. Customs aggregates show $2.7M of exports covering 98 molecules to 16 destinations in 2025.

8
active US DMFs
3
valid CEPs
1
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
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
Ambernath (East), India 3016575313

What they file, and where

Molecule Regulators Docs
Metoprolol SFDA (Saudi Arabia), US FDA 3
Losartan EDQM, US FDA 2
Valaciclovir EDQM, US FDA 2
Venlafaxine EDQM, US FDA 2
Acyclovir US FDA 1
Desvenlafaxine US FDA 1
Fluconazole US FDA 1

Also appears on these molecule pages

Acyclovir API Desvenlafaxine API Fluconazole API Losartan API Metoprolol API Valaciclovir API Valacyclovir API Venlafaxine API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $28K 8
2025 Not reported $2.7M 16
2024 Not reported $2.4M 18
2023 Not reported $2.9M 19

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 We do not publish the identity of any buyer.

Questions about Atul Bioscience

Does Atul Bioscience hold a US DMF or a CEP?
Atul Bioscience holds 8 active US drug master files and 3 valid CEPs. 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 Atul Bioscience FDA-registered?
One site operated by Atul Bioscience 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.
Where does Atul Bioscience manufacture?
1 registered site is on record, in India (Ambernath (east)). Every site is listed on this page with the register it came from.
What does Atul Bioscience make?
7 molecules are on record against Atul Bioscience, including Metoprolol, Losartan, Valaciclovir and Venlafaxine. Each links through to that molecule's full manufacturer list.
Where does Atul Bioscience file?
Filings are on record with MINSA (CR), 1 in total.

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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Comparable suppliers

Hetero shares 7 molecules Zydus Lifesciences shares 7 molecules Apitoria Pharma shares 6 molecules Dr Reddy's Laboratories shares 4 molecules Matrix Pharmacorp 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
Customs aggregates
Export values, molecule and destination counts