Molecules / Azelaic Acid

Azelaic Acid API manufacturers

CAS 123-99-9 ATC D10AX03 Updated 9 July 2026
6
manufacturers with an active filing 4 of them hold a US DMF or a CEP
$346.51
median export price per kg $96.74 to $350.00 · 10 exporters · 2025
110
finished-dose makers across 28 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Bayer S/A

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

Holds 2 active US DMFs for azelaic acid, filing since 1991. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 46 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
46 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Alivus Life Sciences

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

Holds 2 active US DMFs for azelaic acid, filing since 2016. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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03

Flamma

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

Holds one active US DMF for azelaic acid, filing since 2023. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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04

Zhejiang Huahai Pharmaceutical

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

Holds one active US DMF for azelaic acid, filing since 2019. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · OAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Registered with DAV (Vietnam) for azelaic acid. 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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06

Tyche Industries

India
Makes the API

Registered with SFDA (Saudi Arabia) for azelaic acid. Its 2024 FDA inspection closed as OAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · OAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

3 more manufacturers hold filings for azelaic acid

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

Zhejiang Huahai PharmaceuticalCông ty cổ phần Dược phẩm VCPTyche Industries
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Finished-dose makers (12)

LEO Pharma A/S Denmark Glenmark Pharmaceuticals s.r.o Czech Republic Teva Israel Sandoz Switzerland EGO Pharmaceuticals Pty Australia Adcock Ingram South Africa Germed Farmaceutica Ltda Brazil Laboratorios Viñas Spain Medical Union Pharmaceuticals-MUP-Official Egypt Pt. Genero Pharmaceuticals Indonesia Ferron Par Pharmaceuticals Indonesia Saja Pharma Saudi Arabia

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.

Who makes azelaic acid?

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

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Also on this molecule

Price history 1 yrs Recalls 4 Finished dose 12 Contract mfrs 0