Molecules / Ropinirole

Ropinirole API manufacturers

CAS 91374-21-9 ATC N04BC04 Updated 9 July 2026
9
manufacturers with an active filing 9 of them hold a US DMF or a CEP
$6774.37
median export price per kg $4382.10 to $11708.28 · 7 exporters · 2025
90
shortage records on file across 5 countries
266
finished-dose makers across 28 regulators
Showing 9 of 9 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Synthimed Labs

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

Holds 2 active US DMFs and one valid CEP for ropinirole, filing since 2005. Its 2020 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2020 · NAI
GMP recognised in
15 markets
02

Dr. Reddy's Laboratories

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

Holds one active US DMF and one valid CEP for ropinirole, filing since 2005. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
03

Alembic Pharmaceuticals

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

Holds one active US DMF and 2 valid CEPs for ropinirole, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
04

Alivus Life Sciences

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

Holds 2 active US DMFs and one valid CEP for ropinirole, filing since 2007. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
05

Neuland Laboratories

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

Holds 4 active US DMFs and one valid CEP for ropinirole, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
4 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
06

Torrent Pharmaceuticals

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

Holds one active US DMF for ropinirole, filing since 2005. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · NAI
GMP recognised in
20 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

USV

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

Holds one active US DMF for ropinirole, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Orbion Pharmaceuticals

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

Holds one active US DMF for ropinirole, filing since 2008.

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
View profile

6 more manufacturers hold filings for ropinirole

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

Open the full list with a free account

Contract manufacturers (2)

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

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 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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By country

Export price by year

Year Median Exporters
2025 $6774.37 7
2024 $6954.58 7
2023 $7430.00 5
2022 $5934.34 5

US dollars per kilogram, customs export unit values.