5th March, 2020, Vadodara, India
2020-03-01 · Alembic Pharmaceuticals Ltd. · original alembicpharmaceuticals.com ↗
PRESS RELEASE 5th March, 2020, Vadodara, India Alembic Pharmaceuticals announces USFDA Final Approval for Doxycycline Hyclate Tablets USP, 20 mg. Alembic Pharmaceuticals Limited (Alembic) today announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Doxycycline Hyclate Tablets USP, 20 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Periostat Tablets, 20 mg of Galderma Laboratories, L.P. (Galderma). Doxycycline Hyclate Tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. Doxycycline Hyclate Tablets USP, 20 mg have an estimated market size of US$ 7 million for twelve months ending December 2019 according to IQVIA. Alembic has a cumulative total of 119 ANDA approvals (107 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 Alembic 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 Email: [email protected] . Mitanshu Shah Phone: +91 265 - 3007630 Email: [email protected] ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE : ALEMBIC ROAD, VADODARA - 390 003. • TEL : (0265) 2280550, 2280880 • FAX : (0265) 2281229 website: www.alembicpharmaceuticals.com •E-mail: [email protected] • CIN: L24230GJ2010PLC061123
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