Alembic Pharmaceuticals receives USFDA approval for Glycopyrrolate Injection

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 the company's 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.

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