Molecules / Dorzolamide

Dorzolamide API manufacturers

CAS 120279-96-1 ATC S01EC03 Updated 9 July 2026
12
manufacturers with an active filing 9 of them hold a US DMF or a CEP
$2662.84
median export price per kg $2251.30 to $3177.17 · 18 exporters · 2025
47
shortage records on file across 5 countries
492
finished-dose makers across 49 regulators
Showing 12 of 12 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

FDC

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

Holds one active US DMF and 3 valid CEPs for dorzolamide, filing since 2019. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 16 markets.

US DMF
1 active
CEP
3 valid
Last FDA inspection
2023 · NAI
GMP recognised in
16 markets
04

Curia Spain S.A.U

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

Holds one active US DMF for dorzolamide, filing since 2005. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
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05

Hetero

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

Holds 2 active US DMFs for dorzolamide, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

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

Century Pharmaceuticals

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

Holds one active US DMF for dorzolamide, filing since 2020. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dorzolamide, filing since 2015. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Shobha Life Sciences

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

Holds one active US DMF for dorzolamide, 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
09

Olon

Italy
Makes the API

Registered with SFDA (Saudi Arabia) for dorzolamide. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
10

Global Calcium

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

Holds one active US DMF for dorzolamide, filing since 2024. Its 2024 FDA inspection closed as OAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · OAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Crystal Pharma, S.A.U

Spain
Makes the API

Registered with SFDA (Saudi Arabia) for dorzolamide. 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
12

Precise Chemipharma

India
Makes the API

Registered with SFDA (Saudi Arabia) for dorzolamide. 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

9 more manufacturers hold filings for dorzolamide

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

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Contract manufacturers (4)

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.

Who makes dorzolamide?

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

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By country

Sold in these combinations

Fixed-dose combinations containing dorzolamide. Each page leads with the verified API makers of every component.

Export price by year

Year Median Exporters
2025 $2662.84 18
2024 $2600.00 27
2023 $2957.68 24
2022 $3067.17 22

US dollars per kilogram, customs export unit values.