Molecules / Nystatin

Nystatin API manufacturers

CAS 1400-61-9 Updated 9 July 2026
7
manufacturers with an active filing 4 of them hold a US DMF or a CEP
$300.00
median export price per kg $230.06 to $329.29 · 21 exporters · 2025
50
shortage records on file across 7 countries
627
finished-dose makers across 48 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Antibiotice

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

Holds one active US DMF for nystatin, filing since 2000. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
7 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Concord Biotech

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

Holds one active US DMF for nystatin, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.

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

Vuab Pharma

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

Holds one active US DMF for nystatin, filing since 1999.

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
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05

Phil Inter Pharma

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for nystatin. Its GMP is recognised in 3 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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06

Capua Bioservices

Italy
Makes the API

Registered with SFDA (Saudi Arabia) for nystatin.

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
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07

Pharbaco

Vietnam
Makes the API

Registered with DAV (Vietnam) for nystatin. 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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4 more manufacturers hold filings for nystatin

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

Vuab PharmaPhil Inter PharmaCapua BioservicesPharbaco
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Contract manufacturers (1)

Galentic Pharma India

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

Finished-dose makers (87)

Glenmark Pharmaceuticals s.r.o Czech Republic Dr. Reddy's Laboratories India Teva Israel Torrent Pharmaceuticals India Alembic Pharmaceuticals India Epic Pharma United States Genus Lifesciences United States Lupin India Macleods Pharmaceuticals India Sanofi France Taro Pharmaceuticals Israel Zydus Lifesciences India Amneal United States Crown Laboratories United States Leading Pharma United States SmartPractice Denmark ApS Denmark Viatris United States Bristol-Myers Squibb United States Eurofarma Laboratorios Brazil Pharmascience 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
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 2 yrs Shortages 50 Recalls 12 Finished dose 87 Contract mfrs 1

Export price by year

Year Median Exporters
2025 $300.00 21
2024 $310.01 9

US dollars per kilogram, customs export unit values.