Alembic Pharma gets USFDA nod for generic version of Glycopyrrolate injection

Alembic Pharmaceuticals Ltd on Tuesday said it has received final approval from the US health regulator for its generic version of Glycopyrrolate injection used as a pre-operative medication to inhibit salivary gland and respiratory secretions. The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for Glycopyrrolate injection. The approval is for strengths 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, according to a regulatory filing.

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

Glycopyrrolate injection 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, the company said.


As per IQVIA data, Alembic said Glycopyrrolate injection had an estimated market size of USD 42 million for the 12 months ended June 2022.