Alembic Pharmaceuticals Limited (Alembic) announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Metronidazole Gel USP, 1 %. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Metrogel Gel, 1 %, of Galderma Laboratories LP (Galderma). Metronidazole Gel USP, 1 % is indicated for Indicated for the topical treatment of inflammatory lesions of rosacea.

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.

About Aleor Dermaceuticals Limited

Aleor is a 60:40 joint venture between Alembic and Orbicular Pharmaceutical Technologies Pvt Ltd (Orbicular) formed in Apr' 16 focusing on commercialising dermatology products globally.

Contact:

Ajay Kumar Desai

Phone: +91 22 - 306 11681

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