Molecules / Tapentadol / India

Tapentadol API manufacturers in India

CAS 175591-23-8 ATC N02AX06 Updated 9 July 2026
9
India-based manufacturers with an active filing of 9 worldwide
$461.41
median export price per kg, all origins $335.37 to $510.70 · 19 exporters · 2024
Showing 5 of 9 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based API manufacturers

01

Alkem Laboratories

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

Holds 2 active US DMFs for tapentadol, filing since 2012. Its GMP is recognised in 21 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
21 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Ami Lifesciences

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

Holds one valid CEP for tapentadol, filing since 2026. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
03

Symed Labs

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

Holds one valid CEP for tapentadol, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
04

Virupaksha Organics

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

Holds one valid CEP for tapentadol, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
05

MSN Laboratories

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

Holds one active US DMF for tapentadol, filing since 2025. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile

4 more manufacturers in India hold filings for tapentadol

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

Ami LifesciencesSymed LabsVirupaksha OrganicsMSN Laboratories
Open the full list with a free account

How this list is built

This page filters the worldwide Tapentadol 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 Tapentadol manufacturers

Worldwide 9