Molecules / Tapentadol

Tapentadol API manufacturers

CAS 175591-23-8 ATC N02AX06 Updated 9 July 2026
9
manufacturers with an active filing 9 of them hold a US DMF or a CEP
$461.41
median export price per kg $335.37 to $510.70 · 19 exporters · 2024
16
shortage records on file across 3 countries
201
finished-dose makers across 24 regulators
Showing 9 of 9 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked 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

Ampac Fine Chemicals

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

Holds one active US DMF for tapentadol, filing since 2014. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Curia

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

Holds one active US DMF for tapentadol, filing since 2012. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
04

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
05

Grünenthal

Germany
Makes the APIFinished dose

Holds one valid CEP for tapentadol, filing since 2022. Its GMP is recognised in 16 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
16 markets
How this listing is sourced EDQM certificate database
View profile
06

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
07

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
08

Noramco

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

Holds one active US DMF for tapentadol, filing since 2008. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
09

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

6 more manufacturers 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 LifesciencesGrünenthalSymed LabsVirupaksha OrganicsNoramcoMSN Laboratories
Open the full list with a free account

Contract manufacturers (2)

Arene Life Sciences India Ami Lifesciences India

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (22)

Farmaceutici Formenti Italy Epic Pharma United States Zentiva, k.s Czech Republic Dr. Reddy's Laboratories India HIKMA ITALIA Italy Torrent Pharmaceuticals India Viatris United States Micro Labs India Novitium Pharma United States STADA Arzneimittel Germany Adcock Ingram South Africa Janssen-Cilag Farmaceutica Ltda Brazil Laboratorios Liconsa Spain Aristo Pharma Germany Krka Slovenia Medochemie Cyprus Pharose Remedies Limited 22- Milestone India Eg S P A Italy Krka Slovenia Laboratorio Stada S.L Spain

How this list is built

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. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators
Price band
Customs export unit values for 2024. These are export values rather than contract prices for regulated-market grade material, which are higher.

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Also on this molecule

Price history 3 yrs Shortages 16 Recalls 1 Finished dose 22 Contract mfrs 2

By country

India 9

Export price by year

Year Median Exporters
2024 $461.41 19
2023 $422.72 16
2022 $397.89 21

US dollars per kilogram, customs export unit values.