Molecules / Acetazolamide

Acetazolamide API manufacturers

CAS 59-66-5 ATC S01EC01 Updated 9 July 2026
7
manufacturers with an active filing 6 of them hold a US DMF or a CEP
$73.70
median export price per kg $55.54 to $75.46 · 32 exporters · 2025
15
shortage records on file across 3 countries
182
finished-dose makers across 49 regulators
Showing 7 of 7 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Gland Pharma

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

Holds one active US DMF for acetazolamide, filing since 2022. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Nakoda Chemicals

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

Holds one active US DMF for acetazolamide, filing since 2006. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Zaklady Farmaceutyczne Polpharma

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

Holds one active US DMF for acetazolamide, filing since 1993. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

CTX Lifesciences

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

Holds one valid CEP for acetazolamide, filing since 2022. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
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05

Idt Australia

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

Holds one active US DMF for acetazolamide, filing since 1998. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

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

Regis Technologies

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

Holds 2 active US DMFs for acetazolamide, filing since 2009. Its 2022 FDA inspection closed as VAI.

US DMF
2 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
07

Pharmedic S A

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for acetazolamide. 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 acetazolamide

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

CTX LifesciencesIdt AustraliaRegis TechnologiesPharmedic S A
Open the full list with a free account

Contract manufacturers (3)

CTX Lifesciences India Avery Chemical Nantong China Polpharma Group Poland

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

Finished-dose makers (41)

Ajanta Pharma India HIKMA ITALIA Italy Viatris United States Alembic Pharmaceuticals India Aarkish Pharmaceuticals NJ United States Hospira United States Teva Israel Torrent Pharmaceuticals India Remedica Cyprus Cooperation Pharmaceutique Francaise France ANI Pharmaceuticals United States Ingenus Pharmaceuticals United States Centaur Pharmaceuticals India Epic Pharma United States Mankind Pharma India Micro Labs India Pfizer Brasil Ltda Brazil Zydus Lifesciences India Medicamen Biotech India Laboratorios Alcala Farma, S.L Spain

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 15 Recalls 6 Finished dose 41 Contract mfrs 3

Export price by year

Year Median Exporters
2025 $73.70 32
2024 $58.00 14
2023 $98.96 13
2022 $64.43 13

US dollars per kilogram, customs export unit values.