Alembic Pharmaceuticals 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 our 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.
Glycopyrrolate Injection USP, has an estimated market size of $ 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 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
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