Alembic Pharma gets USFDA nod for Glycopyrrolate injection

The drug maker on Tuesday announced that it has received a final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Injection USP.

The pharmaceutical company said that this is the first injectable product approval from its General Sterile Facility (F-3) which was inspected in August 2022.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), of Hikma Pharmaceuticals USA Inc. (Hikma).

Glycopyrrolate injection is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the volume and free acidity of gastric secretions; and to block cardiac vagal inhibitory reflexes during induction of anesthesia and intubation. When indicated, Glycopyrrolate Injection may be used intraoperatively to counteract surgically or drug-induced or vagal reflexes associated arrhythmias. It is also indicated for use in adults as adjunctive therapy for the treatment of peptic ulcer when rapid anticholinergic effect is desired or when oral medication is not tolerated.

According to IQVIA, Glycopyrrolate Injection USP, has an estimated market size of $42 million for twelve months ending June 2022.

Alembic has a cumulative total of 173 ANDA approvals (149 final approvals and 24 tentative approvals) from USFDA.

Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.

The company reported a consolidated net loss of Rs 65.88 crore in Q1 FY23 as against a net profit of Rs 164.52 crore posted in Q1 FY22. Net sales fell 4.8% year on year to Rs 1,262.14 crore in the quarter ended 30 June 2022.

Shares of Alembic Pharmaceuticals were up 0.55% to Rs 553 on the BSE.

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