- Source : Press Release
- Date : 2019-08-13
- Event type : Approved
- Companies : Alembic Pharmaceuticals Ltd.
Alembic Pharmaceuticals Receives USFDA Approval for Dorzolamide Hydrochloride Ophthalmic Solution USP, 2%
Alembic Pharmaceuticals Limited today announced that the Company has received
approval from the US Food & Drug Administration (USFDA) for its Abbreviated New
Drug Application (ANDA) for Dorzolamide Hydrochloride Ophthalmic Solution USP,
2%. The approved ANDA is therapeutically equivalent to the reference listed drug
product (RLD) Trusopt Ophthalmic Solution, 2%, of Merck Sharp & Dohme Corp.
Dorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor
indicated in the treatment of elevated intraocular pressure in patients with ocular
hypertension or open-angle glaucoma.
Dorzolamide Hydrochloride Ophthalmic Solution USP, 2% has an estimated market
size of US$ 35 million for twelve months ending December 2018 according to IQVIA.
Alembic now has a total of 101 ANDA approvals (89 final approvals and 12 tentative
approvals) from USFDA.
About Alembic Pharmaceuticals Limited
Alembic Pharmaceuticals Limited, a vertically integrated research and development
pharmaceutical company, has been at the forefront of healthcare since 1907.
Headquartered in India, Alembic is a publicly listed company that manufactures and
markets generic pharmaceutical products all over the world. Alembic's state of the art
research and manufacturing facilities are approved by regulatory authorities of many
developed countries including the USFDA. Alembic is one of the leaders in branded
generics in India. Alembic's brands, marketed through a marketing team of over 5000
are well recognized by doctors and patients.
Information about the company can be found
at http://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS) (Bloomberg:
ALPM) (NSE: APLL TD) (BSE: 533573)
For more information contact:
Ajay Kumar Desai
Phone: 91 22 - 306 11681
Phone: 91 265 - 3007630
ALEMBIC PHARMACEUTICALS LIMITED
REG~. OFFICE : ALE~BIC ROAD, VADODARA - 390 003. • TEL : (0265) 2280550, 2280880 • FAX : (0265) 228t229
website : www.alemb1cpharmaceuticals.com • E-mail : [email protected] • CIN : L24230GJ2010PLC061123