3151July, 2017, Vadodara, India
PRESS RELEASE
Alembic Pharmaceuticals receives USFDA Approval for Doxycycli ne Capsules USP,75 mg and 1 00 mg.
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 Doxycycline Capsules USP, 75 mg and 100 mg.The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD} Monodox® Capsules,75 mg and 100 mg,of Aqua Pharmaceuticals.Doxycycline Capsules are indicated for the treatment and prevention of infections that are proven or strongly suspected to be caused by bacteria.
Doxycycline Capsules USP, 75 mg and 100 mg,have an estimated market size of US$ 30 million for twelve months ending December 2016 according to IMS.
Alembic now has a total of 62 ANDA approvals (54 final approvals and 8 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.Alemb ic'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: APLLTD) (BSE: 533573)
For more information contact:
Ajay Kumar Desai
Phone:+91 22 -306 11681
Email:ajay.desai@alembic .co.i n
Mitanshu Shah
Phone: +91 265 - 3007630
Email:mitanshu .shah@alembic. co.i n
ALEMBIC PHARMACEUTICALS LIMITED
REG.OFFICE :ALE BIC ROAD, VADODARA • 390 003. • TEL :(0265) 2280550,2280880 • FAX :(0265) 2281229
website :www.alemb1cpharmaceuticals.com • E-mail:alembic@alembic.co.in • CIN :L24230GJ2010PLC061123