Molecules / Phenylalanine

Phenylalanine API manufacturers

CAS 63-91-2 Updated 9 July 2026
4
manufacturers with an active filing 4 of them hold a US DMF or a CEP
$75.00
median export price per kg $51.98 to $80.79 · 9 exporters · 2024
1
shortage records on file across 1 countries
276
finished-dose makers across 14 regulators
Showing 4 of 4 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 phenylalanine, filing since 1980. 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
03

Kyowa Hakko Bio

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

Holds one valid CEP for phenylalanine, 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
04

Shanghai Plumino Amino Acid

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

Holds one valid CEP for phenylalanine, 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

1 more manufacturer holds filings for phenylalanine

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

Kyowa Hakko BioShanghai Plumino Amino Acid
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Contract manufacturers (3)

Flamma Italy Chengdu Tlktech China Chiral Quest Suzhouco United States

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

Finished-dose makers (31)

Fresenius Kabi Ab Sweden Otsuka Pharmaceutical India India Baxter SA-NV Belgium Pierre Fabre Médicament; France Vantive Belgium Belgium Advanced Accelerator Applications France Merz Pharma Gmbh & Co. Kgaa Germany Novo Nordisk A/S Denmark Yichang Sanxia Pharmaceutical China B. Braun Melsungen Germany "West-Coast Pharmaceutical Works India 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

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 2024. These are export values rather than contract prices for regulated-market grade material, which are higher.

Who makes phenylalanine?

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

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Also on this molecule

Price history 2 yrs Shortages 1 Recalls 1 Finished dose 31 Contract mfrs 3

Export price by year

Year Median Exporters
2024 $75.00 9
2023 $59.97 9

US dollars per kilogram, customs export unit values.