Molecules / Serine

Serine API manufacturers

CAS 56-45-1 Updated 9 July 2026
6
manufacturers with an active filing 5 of them hold a US DMF or a CEP
2
shortage records on file across 2 countries
258
finished-dose makers across 14 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 valid CEP for serine, filing since 2020. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
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02

Kyowa Hakko Bio

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

Holds one valid CEP for serine, filing since 2016. 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
03

Otsuka Pharmaceutical India

India
Makes the APIFinished dose

Registered with DAV (Vietnam) for serine. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 36 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
36 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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04

Ajinomoto

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

Holds 2 active US DMFs and 2 valid CEPs for serine, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
2 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
4 markets
How this listing is sourced EDQM certificate database
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 serine, 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 serine

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

AjinomotoShanghai Plumino Amino AcidMianyang Shengshi Health Technology
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Contract manufacturers (3)

Flamma Italy Globela Pharma India Ami Lifesciences India

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

Finished-dose makers (27)

Fresenius Kabi Ab Sweden Baxter SA-NV Belgium Vantive Belgium Belgium Advanced Accelerator Applications France Merz Pharma Gmbh & Co. Kgaa Germany Yichang Sanxia Pharmaceutical China Aculife Healthcare India Avantika Medex India B. Braun Melsungen Germany 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 "Tianjin Kingyork Group Hubei Tianyao Pharmaceutical Co.,Ltd " China

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 serine?

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

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Also on this molecule

Shortages 2 Finished dose 27 Contract mfrs 3