Molecules / Halobetasol

Halobetasol API manufacturers

CAS 66852-54-8 ATC D07AC21 Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
14
finished-dose makers across 2 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Wavelength Enterprises

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

Holds 4 active US DMFs for halobetasol, filing since 2003. Its 2022 FDA inspection closed as NAI.

US DMF
4 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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02

Sterling

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

Holds one active US DMF for halobetasol, filing since 2003. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Symbiotec Pharmalab

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

Holds one active US DMF for halobetasol, filing since 2006. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Hovione Farmaciência

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

Holds 2 active US DMFs for halobetasol, filing since 2003. Its GMP is recognised in 2 markets.

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

Trifarma

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

Holds one active US DMF for halobetasol, filing since 2005. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

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

3 more manufacturers hold filings for halobetasol

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

Hovione FarmaciênciaTrifarmaSymbiotica Speciality Ingredients Sdn.Bhd
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Contract manufacturers (4)

Hovione Farmaciência Portugal Aurisco Pharmaceutical Co.,Ltd China Symbiotica Speciality Ingredients Sdn.Bhd Malaysia Hunan Yuxin Pharmaceutical China

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

Finished-dose makers (4)

Gilead Sciences United States Cosette Pharmaceuticals United States Padagis Israel Israel Valeant Canada Limitée Canada

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

Who makes halobetasol?

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

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Also on this molecule

Recalls 5 Finished dose 4 Contract mfrs 4