Alembic Pharmaceuticals Announces First Injectable Product Approval of Final General Sterile Facility Approval for Glycopyrrolate Injection USP

Alembic Pharmaceuticals Limited (Alembic) announced today that it has received final approval from the US Food and 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) multidose 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 drug product (RLD), Hikma Pharmaceuticals USA Inc. (Hikma). Injectable glycopyrrolate is indicated 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 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 $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.

About Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limiteda vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly traded company that manufactures and markets generic pharmaceutical products worldwide. Alembic’s state-of-the-art research and manufacturing facilities are approved by regulatory authorities in many developed countries, including the USFDA. Alembic is one of the leading branded generics in India. Alembic’s brands, marketed by a marketing team of more than 5,000 people, are well recognized by doctors and patients.


Ajay Kumar Desai

Tel: +91 22 – 306 11681

Email: [email protected]

(C) 2022 electronic news edition, source ENP Newswire