You are here: Home » News-CM » Companies » News
Business Standard

Alembic Pharmaceuticals' subsidiary gets USFDA approval for Glycopyrrolate Tablets

Capital Market 

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.

Powered by Capital Market - Live News

(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
RECOMMENDED FOR YOU
RECOMMENDED FOR YOU