Molecules / Phenobarbital

Phenobarbital API manufacturers

CAS 50-06-6 ATC N03AA02 Updated 9 July 2026
8
manufacturers with an active filing 7 of them hold a US DMF or a CEP
$54.63
median export price per kg $45.27 to $97.75 · 9 exporters · 2025
29
shortage records on file across 8 countries
309
finished-dose makers across 49 regulators
Showing 8 of 8 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Harman Finochem

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

Holds 2 active US DMFs and one valid CEP for phenobarbital, filing since 2004. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

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

Nantong Jinghua Pharmaceutical

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

Holds one active US DMF for phenobarbital, filing since 2017. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Siegfried USA

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

Holds one active US DMF for phenobarbital, filing since 1967. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Shandong Xinhua Pharmaceutical

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

Holds 2 active US DMFs for phenobarbital, filing since 2013. Its GMP is recognised in 5 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Chemische Fabrik Berg

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

Holds one valid CEP for phenobarbital, filing since 2023. Its 2024 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
08

Registered with DAV (Vietnam) for phenobarbital. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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5 more manufacturers hold filings for phenobarbital

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 (4)

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

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 $54.63 9
2024 $64.50 8
2023 $77.15 9
2022 $75.22 5

US dollars per kilogram, customs export unit values.