Molecules / Naltrexone / India

Naltrexone API manufacturers in India

CAS 16590-41-3 ATC N07BB04 Updated 9 July 2026
5
India-based manufacturers with an active filing of 12 worldwide
$6145.00
median export price per kg, all origins $5006.35 to $8905.13 · 10 exporters · 2025
Showing 3 of 5 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based API manufacturers

01

Rusan Pharma

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for naltrexone, filing since 2023. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 11 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
11 markets
How this listing is sourced EDQM certificate database
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02

Sthree Chemicals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for naltrexone, filing since 2025.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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03

Registered with SFDA (Saudi Arabia) for naltrexone.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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2 more manufacturers in India hold filings for naltrexone

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Sthree ChemicalsSun Pharmaceutical Industries Ltd., Gujarat, India
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How this list is built

This page filters the worldwide Naltrexone manufacturer list to companies based in India. The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Read the full method.

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All Naltrexone manufacturers

Worldwide 12