Alembic Pharma subsidiary gets USFDA nod for Glycopyrrolate tablets

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

Dec 04, 2018 09:12 IST India Infoline News Service

Alembic Pharmaceuticals
Alembic Pharmaceuticals Ltd (Alembic), in a release to the exchanges on Tuesday, announced that its wholly-owned subsidiary Orit Laboratories LLC has received approval from the USFDA for its ANDA Glycopyrrolate tablets USP, 1 mg and 2 mg.

According to IQVIA, Glycopyrrolate Tablets USP, 1 mg and 2 mg, had an estimated market size of $15mn to the twelve months ending December 2017.

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

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.

Alembic Pharmaceuticals Ltd share price is currently at Rs616.20, up 0.09% from its previous close of Rs615.65 on the BSE.

The scrip opened at Rs615.50 and has touched a high and low of Rs622 and Rs615, respectively.

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