Molecules / Istradefylline

Istradefylline API manufacturers

CAS 155270-99-8 Updated 9 July 2026
5
manufacturers with an active filing 4 of them hold a US DMF or a CEP
3
finished-dose makers across 3 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

MSN Laboratories

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

Holds one active US DMF for istradefylline, filing since 2023. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Hoster Labs

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

Holds one active US DMF for istradefylline, filing since 2024.

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

PROCOS

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

Holds one active US DMF for istradefylline, filing since 2023. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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05

Kyungdongpharm.Co.,Ltd

South Korea
Makes the API

Registered with PMDA (Japan) for istradefylline.

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 hold filings for istradefylline

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

Alp Pharm BeijingKyungdongpharm.Co.,Ltd
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Contract manufacturers (1)

PROCOS Italy

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

Finished-dose makers (1)

Kyowa Kirin Japan

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

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Also on this molecule

Finished dose 1 Contract mfrs 1