Alembic Pharma’s subsidiary gets USFDA nod peptic ulcer drug

NEW DELHI, Dec 4: Drug firm Alembic Pharmaceuticals Tuesday said its subsidiary has received the US health regulator’s nod for Glycopyrrolate tablets, used in the treatment of peptic ulcer.
The company’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 in the strengths of 1 mg and 2mg, Alembic Pharmaceuticals said in a BSE filing.
The product is a therapeutic equivalent of Casper Pharma’s Robinul and Robinul Forte tablets, it added.
Quoting IQVIA data, Alembic Pharmaceuticals said Glycopyrrolate tablets USP, 1 mg and 2 mg have an estimated market size of USD 15 million for 12 months ending December 2017.
The company now has a total of 81 ANDA approvals from the USFDA.


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