Orit Laboratories LLC receives USFDA Approval for Glycopyrrolate Tablets USP, 1 mg and 2 mg

Deepthi | Myequity news | Date : 04-12-2018 11:00:00 IST

Alembic’s wholly owned subsidiary Orit Laboratories LLC has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Glycopyrrolate Tablets USP, 1 mg and 2 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Robinul and Robinul Forte Tablets, 1 mg and 2 mg, of Casper Pharma LLC (Casper Pharma). Glycopyrrolate Tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.

Glycopyrrolate Tablets USP, 1 mg and 2 mg have an estimated market size of US$ 15 million for twelve months ending December 2017 according to IQVIA.

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.

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