Molecules / Miconazole

Miconazole API manufacturers

CAS 22916-47-8 Updated 9 July 2026
16
manufacturers with an active filing 8 of them hold a US DMF or a CEP
$60.50
median export price per kg $41.55 to $70.23 · 40 exporters · 2025
8
shortage records on file across 3 countries
524
finished-dose makers across 46 regulators
Showing 16 of 16 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

04

Erregierre

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

Holds one active US DMF for miconazole, filing since 1987. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 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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05

Quimica Sintetica

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

Holds one active US DMF for miconazole, filing since 1989. 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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06

Yung Zip Chemical Ind

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

Holds 2 active US DMFs for miconazole, filing since 1987. Its 2023 FDA inspection closed as VAI.

US DMF
2 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
View profile
07

Gufic Biosciences

India
Makes the API

Registered with SFDA (Saudi Arabia) for miconazole. Its GMP is recognised in 9 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
9 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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08

Sa Ajinomoto Omnichem

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

Holds one active US DMF for miconazole, filing since 2014. 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
09

Pranami Drugs

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

Holds one active US DMF for miconazole, filing since 2025.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Registered with SFDA (Saudi Arabia) for miconazole.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
12

Meyer Bpc Joint Venture

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for miconazole. Its GMP is recognised in 2 markets.

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

Registered with DAV (Vietnam) for miconazole. 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
14

Công ty TNHH Liên doanh Hasan - Dermapharm

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for miconazole. 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
15

Công ty cổ phần Tập đoàn Merap

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for miconazole. 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
16

Minh

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for miconazole. 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

Contract manufacturers (3)

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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By country

Export price by year

Year Median Exporters
2025 $60.50 40
2024 $60.00 39
2023 $64.46 43
2022 $64.83 33

US dollars per kilogram, customs export unit values.