Alembic Pharmaceuticals Announces Approval of its First Injectable Product by its General Sterility Facility – Final Approval for Glycopyrrolate Injection USP

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  • Source: PA
  • Date: November 01, 2022

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Injection USP, 0.2mg /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 ) Multi-dose vials.

This is the first injectable product approval from our General Sterile Facility (F-3) which was inspected in August 2022.

The approved ANDA is therapeutically equivalent to Hikma Pharmaceuticals USA Inc.’s (Hikma) reference drug product (RLD). Injectable glycopyrrolate is indicated as a preoperative antimuscarinic to reduce salivary, tracheobronchial and pharyngeal secretions; 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 can be used intraoperatively to counteract arrhythmias associated with surgical, drug, or vagal reflexes. Glycopyrrolate protects against the peripheral muscarinic effects (eg, bradycardia and excessive secretions) of cholinergic agents such as neostigmine and pyridostigmine given to reverse neuromuscular blockade due to nondepolarizing muscle relaxants. It is also indicated in adults as an adjunctive therapy for the treatment of peptic ulcer disease when a rapid anticholinergic effect is desired or when oral medications are not tolerated.

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

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