Molecules / Promethazine

Promethazine API manufacturers

CAS 60-87-7 ATC D04AA10 Updated 9 July 2026
6
manufacturers with an active filing 5 of them hold a US DMF or a CEP
$71.83
median export price per kg $62.01 to $93.98 · 37 exporters · 2025
7
shortage records on file across 4 countries
296
finished-dose makers across 35 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Egis Pharmaceuticals

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

Holds one active US DMF for promethazine, filing since 1989. Its 2018 FDA inspection closed as NAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · NAI
GMP recognised in
20 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Sanofi Winthrop Industrie

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

Holds one valid CEP for promethazine, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 17 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
17 markets
How this listing is sourced EDQM certificate database
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03

Sanofi

France
Makes the APIFinished dose

Holds one active US DMF for promethazine, filing since 1972. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 33 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
33 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Zydus Lifesciences

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

Holds one active US DMF for promethazine, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Registered with DAV (Vietnam) for promethazine. 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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3 more manufacturers hold filings for promethazine

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

Zydus LifesciencesAreva Synthetics: Công Ty Cp Dược Vật Tư Y Tế Hà Nam
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Contract manufacturers (1)

Swiss Parenterals India

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

Finished-dose makers (74)

Fresenius Kabi Ab Sweden Amneal United States Teva Israel Genus Lifesciences United States PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma United States Apotex Canada Glenmark Pharmaceuticals s.r.o Czech Republic HIKMA ITALIA Italy Harman Finochem India Hospira United States Quagen Pharmaceuticals United States ANI Pharmaceuticals United States Xepa-Soul Pattinson (Malaysia) Sdn Bhd Malaysia Opella Healthcare Brazil Ltda Brazil Pfizer Brasil Ltda Brazil Cosette Pharmaceuticals United States Epic Pharma United States Pfizer United States Pharmascience Canada Sandoz Switzerland

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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Also on this molecule

Price history 4 yrs Shortages 7 Recalls 10 Finished dose 74 Contract mfrs 1

Export price by year

Year Median Exporters
2025 $71.83 37
2024 $71.00 37
2023 $75.74 38
2022 $75.00 42

US dollars per kilogram, customs export unit values.