Alembic Pharmaceuticals receives USFDA approval for Glycopyrrolate Injection

3 Nov 2022 , 01:33 AM

Alembic Pharmaceuticals has received final approval from the US Food Drug Administration USFDA for its Abbreviated New Drug Application ANDA for Glycopyrrolate Injection USP 02 mg1 mL and 04 mg2 mL 02 mgmL Single-dose Vials and 1 mg5 mL 02 mgmL and 4 mg20 mL 02 mgmL Multiple-dose Vials This is the first injectable product approval from the companys General Sterile Facility F-3 which was inspected in August 2022 Glycopyrrolate Injection USP has an estimated market size of US$ 42 million for twelve months ending June 2022 according to IQVIA