Carbonic Anhydrase Inhibitor, beta-Adrenergic Blocker
Where is Dorzolamide and Timolol made?
19 companies sell it under their own name and 3 repackagers rebottle it. Their labels name 11 factories in India, the United States, Switzerland and France.
India 7United States 2Switzerland 1France 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Akorn Dorzolamide Hydrochloride and Timolol Maleate5 mg per 1 mL / 20 mg per 1 mL · NDC 50383-233, 50383-261 | AkornMakes it and packages it | Location not on file | Not inspected on record |
| Ophtapharm AGMakes it, tests it and packages it | Hettlingen, Switzerland | Problems found, fixed voluntarilyFeb 2020 | |
| Woodstock Sterile Solutions, Inc.Makes it | Woodstock, IL, United States | No problems foundOct 2022 | |
| Alembic Pharmaceuticals Inc.5 mg per 1 mL / 20 mg per 1 mL · NDC 62332-553 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Gland Pharma LimitedMakes it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 | |
| Florida Pharmaceutical Products, LLC.5 mg per 1 mL / 20 mg per 1 mL · NDC 71921-226 | Gland Pharma LimitedMakes it and tests it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Indoco Remedies LimitedMakes it, tests it, packages it and labels it | Goa, India | Serious problems, FDA actionFeb 2023 | |
| Akorn Cosopt5 mg per 1 mL / 20 mg per 1 mL · NDC 17478-605 | Ophtapharm AGMakes it, tests it, packages it and labels it | Hettlingen, Switzerland | Problems found, fixed voluntarilyFeb 2020 |
| Alembic Pharmaceuticals Limited5 mg per 1 mL / 20 mg per 1 mL · NDC 46708-553 | Alembic Pharmaceuticals LimitedMakes it | Vadodara, India | Problems found, fixed voluntarilyFeb 2026 |
| Aurobindo Pharma Limited5 mg per 1 mL / 20 mg per 1 mL · NDC 65862-946, 65862-947 | Eugia Pharma Specialities LimitedMakes it, tests it and packages it | Sangareddy, India | Serious problems, FDA actionFeb 2026 |
| Bausch & Lomb Incorporated5 mg per 1 mL / 20 mg per 1 mL · NDC 24208-486 | Bausch & Lomb IncorporatedMakes it | Tampa, FL, United States | Serious problems, FDA actionMar 2026 |
| Biocon Pharma Inc.5 mg per 1 mL / 20 mg per 1 mL · NDC 70377-082 | Indoco Remedies LimitedMakes it, tests it, packages it and labels it | Goa, India | Serious problems, FDA actionFeb 2023 |
| FDC Limited5 mg per 1 mL / 20 mg per 1 mL · NDC 55545-1007 | FDC LimitedMakes it and tests it | Chhatrapati Sambhajinagar, India | No problems foundFeb 2023 |
| Gland Pharma Limited5 mg per 1 mL / 20 mg per 1 mL · NDC 68083-490 | Gland Pharma LimitedMakes it, tests it and packages it | Hyderabad, India | Problems found, fixed voluntarilyJul 2024 |
| Indoco Remedies Limited5 mg per 1 mL / 20 mg per 1 mL · NDC 14445-405 | Indoco Remedies LimitedMakes it, tests it, packages it and labels it | Goa, India | Serious problems, FDA actionFeb 2023 |
| Ingenus Pharmaceuticals, LLC5 mg per 1 mL / 20 mg per 1 mL · NDC 50742-323 | Kaysersberg PharmaceuticalsMakes it, tests it, packages it and labels it | Kaysersberg-Vignoble, France | Problems found, fixed voluntarilyMay 2024 |
| Leading Pharma, LLC5 mg per 1 mL / 20 mg per 1 mL · NDC 69315-305 | FDC LimitedMakes it and tests it | Chhatrapati Sambhajinagar, India | No problems foundFeb 2023 |
| Micro Labs Limited5 mg per 1 mL / 20 mg per 1 mL, 6.8 mg per 1 mL / 22.3 mg per 1 mL · NDC 42571-382, 42571-147 | Micro Labs LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Problems found, fixed voluntarilyJun 2026 |
| Somerset Therapeutics, LLC5 mg per 1 mL / 20 mg per 1 mL · NDC 70069-051 | Somerset Therapeutics Private LimitedMakes it, tests it, packages it and labels it | Bengaluru, India | Serious problems, FDA actionFeb 2025 |
| Akorn Cosopt Pf5 mg per 1 mL / 20 mg per 1 mL · NDC 17478-604 | The label doesn't name the factory. Plants this company names for other drugs | ||
| ImprimisRx NJ5 mg per 1 mL / 20 mg per 1 mL · NDC 70261-519 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Sandoz Inc.5 mg per 1 mL / 20 mg per 1 mL · NDC 61314-030 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Thea Pharma Inc. Cosopt, Cosopt Pf5 mg per 1 mL / 20 mg per 1 mL · NDC 82584-605, 82584-604 | The label doesn't name the factory. Plants this company names for other drugs | ||
Repackaged by
These companies buy Dorzolamide and Timolol in bulk and rebottle it, often for mail-order, clinic or hospital pharmacies. If your bottle shows one of these names, open its NDC to see who made the pills inside.
- A-S Medication Solutions:
50090-6371,50090-2867 - Bryant Ranch Prepack:
72162-2184,72162-2387,72162-2166,72162-2381 - Physicians Total Care, Inc.:
54868-4279,54868-5982
Recalls
- Jul 22, 2026 · Class II · Micro Labs Usa Inc
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. - Dec 20, 2018 · Class III · Akorn Inc
Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.