Molecules / Proline

Proline API manufacturers

CAS 147-85-3 Updated 9 July 2026
5
manufacturers with an active filing 4 of them hold a US DMF or a CEP
1
shortage records on file across 1 countries
261
finished-dose makers across 15 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Kyowa Hakko Bio

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

Holds one valid CEP for proline, filing since 2017. Its 2024 FDA inspection closed as NAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
02

Ajinomoto

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

Holds one active US DMF and one valid CEP for proline, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
4 markets
How this listing is sourced EDQM certificate database
View profile
03

Shanghai Plumino Amino Acid

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

Holds one valid CEP for proline, filing since 2025. Its 2023 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
04

AMINO

Germany
Makes the API

Registered with SFDA (Saudi Arabia) for proline. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
05

Evonik Rexim Sas

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

Holds one active US DMF for proline, filing since 2012.

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

2 more manufacturers hold filings for proline

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

AMINOEvonik Rexim Sas
Chat with Fred, your AI analyst

Contract manufacturers (4)

Flamma Italy Luna Chemicals China Avery Chemical Nantong China Senn Chemicals Switzerland

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

Finished-dose makers (28)

Fresenius Kabi Ab Sweden Otsuka Pharmaceutical India India Baxter SA-NV Belgium Vantive Belgium Belgium Advanced Accelerator Applications France Merz Pharma Gmbh & Co. Kgaa Germany Yichang Sanxia Pharmaceutical China B. Braun Melsungen Germany Aculife Healthcare India Avantika Medex India Baxter Hospitalar Ltda Brazil Cisen Pharmaceutical China Laboratorios B Braun Spain Shandong Qidu Pharmaceutical Co.,Ltd China Shukra Pharmaceuticals India Sichuan Kelun Pharmaceutical China «B. Braun Medical» Portugal "Ultra Laboratories India Tablets India India

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

Who makes proline?

Ask Fred which manufacturers are on record for proline and what filings they hold.

Chat with Fred, your AI analyst
Opens WhatsApp. Free to start.

Also on this molecule

Shortages 1 Recalls 2 Finished dose 28 Contract mfrs 4