Molecules / Phenytoin

Phenytoin API manufacturers

CAS 57-41-0 ATC N03AB02 Updated 9 July 2026
6
manufacturers with an active filing 5 of them hold a US DMF or a CEP
$28.39
median export price per kg $18.84 to $35.00 · 16 exporters · 2025
49
shortage records on file across 5 countries
245
finished-dose makers across 40 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Harman Finochem

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

Holds one active US DMF and one valid CEP for phenytoin, filing since 2004. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
3 markets
02

Orchid Pharma

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

Holds one active US DMF for phenytoin, filing since 2007. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
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Credentials confirmed against the regulator files on 25 July 2026

Holds 3 active US DMFs for phenytoin, filing since 1982. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

US DMF
3 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
15 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Katwijk Chemie

Netherlands
Makes the API

Registered with SFDA (Saudi Arabia) for phenytoin.

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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3 more manufacturers hold filings for phenytoin

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

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Contract manufacturers (5)

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 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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Export price by year

Year Median Exporters
2025 $28.39 16
2024 $25.81 14
2023 $30.80 11
2022 $30.51 12

US dollars per kilogram, customs export unit values.