Molecules / Ketotifen

Ketotifen API manufacturers

CAS 34580-13-7 ATC R06AX17 · Antihistamines Updated 9 July 2026
5
manufacturers with an active filing 3 of them hold a US DMF or a CEP
14
shortage records on file across 7 countries
397
finished-dose makers across 45 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Olon

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

Holds one active US DMF and one valid CEP for ketotifen, filing since 2002. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

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

Laboratori Alchemia

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

Holds one valid CEP for ketotifen, filing since 2020. Its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
03

Zhejiang Huahai Pharmaceutical

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

Holds one valid CEP for ketotifen, filing since 2017. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · OAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
04

Công ty Cổ phần Dược phẩm CPC1 Hà Nội

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for ketotifen. 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
View profile
05

Công ty TNHH Liên doanh Hasan - Dermapharm

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for ketotifen. 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
View profile

2 more manufacturers hold filings for ketotifen

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

Open the full list with a free account

Contract manufacturers (1)

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

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