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Alembic Pharmaceuticals' subsidiary gets USFDA approval for Glycopyrrolate Tablets

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announced its wholly owned subsidiary Orit Laboratories LLC has received approval from the (USFDA) for its Application (ANDA) Glycopyrrolate Tablets USP, 1 mg and 2 mg.

The approved ANDA is therapeutically equivalent to the reference listed (RLD), Robinul and Robinul Forte Tablets, 1 mg and 2 mg, of (Casper Pharma). Glycopyrrolate Tablets are indicated for use as in the treatment of

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.

Alembic has a cumulative total of 81 ANDA approvals (68 final approvals and 13 tentative approvals) from USFDA.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Tue, December 04 2018. 10:49 IST