USFDA gives approval for Glycopyrrolate injection

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

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USFDA Drug product Approval
USFDA Approval

Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for glycopyrrolate injection USP, 0.2 mg/1 ml and 0.4 mg/2 ml (0.2 mg/ml) single-dose vials, and 1 mg/5 ml (0.2 mg/ml) and 4 mg/20 ml (0.2 mg/ml) multiple-dose vials.

This is the first injectable product approval from the general sterile facility (F-3) of Alembic, which was inspected in August 2022.

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

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 with arrhythmias.

Glycopyrrolate protects against the peripheral muscarinic effects (e.g., bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse the neuromuscular blockade due to non-depolarizing muscle relaxants.

It is also indicated for use in adults as adjunctive therapy for the treatment of peptic ulcers when the rapid anticholinergic effect is desired or when oral medication is not tolerated.

Glycopyrrolate injection (USP) has an estimated market size of USD 42 million for the twelve months ending June 2022, according to IQVIA.

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

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