Moneycontrol
Last Updated : Dec 04, 2018 10:47 AM IST | Source: Moneycontrol.com

Alembic Pharma gains 1% on USFDA approval for drug that treats peptic ulcer

Glycopyrrolate has an estimated market size of $15 million for twelve months ending December 2017, according to IQVIA.

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Alembic Pharmaceuticals shares climbed a percent in morning on Tuesday after the subsidiary received approval for drug that is used in the treatment of peptic ulcer.

"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 company said in its filing.

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.

Glycopyrrolate tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer.

Glycopyrrolate has an estimated market size of $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.

At 10:38 hours IST, the stock was quoting at Rs 617.60, up Rs 1.95, or 0.32 percent on the BSE.
First Published on Dec 4, 2018 10:47 am
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