Molecules / Alanine

Alanine API manufacturers

CAS 56-41-7 Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
1
shortage records on file across 1 countries
292
finished-dose makers across 22 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

AMINO

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

Holds one active US DMF and one valid CEP for alanine, filing since 2023. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
04

Kyowa Hakko Bio

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

Holds one valid CEP for alanine, filing since 2014. 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
05

Shanghai Plumino Amino Acid

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

Holds one valid CEP for alanine, 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

3 more manufacturers hold filings for alanine

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

Kyowa Hakko BioShanghai Plumino Amino AcidShijiazhuang Jirong Pharmaceutical
Open the full list with a free account

Contract manufacturers (8)

Flamma Italy Yuki Gosei Kogyo Japan Astatech Chengdu Biopharmaceutical China Chengdu Tlktech China Chiral Quest Suzhouco United States Merck Life Science India Sichuan Jiaying Lai Technology China Suli Pharmaceutical Technology Jiangyin China

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

Finished-dose makers (32)

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 Serum Institute Of India India 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 Pharmachem Germany Shandong Qidu Pharmaceutical Co.,Ltd China Shukra Pharmaceuticals India Sichuan Kelun Pharmaceutical China «B. Braun Medical» Portugal

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

Map alanine for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

Also on this molecule

Shortages 1 Recalls 7 Finished dose 32 Contract mfrs 8

By country

China 5