Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Glycopyrrolate Injection USP, a generic equivalent of Robinul Injection, 0.2 mg/mL of Hikma Pharmaceuticals USA Inc.
The product marks the first approval from Lupin's new injectable facility in Nagpur, India. Lupin's state-of-the-art injectable facility is designed to the highest quality standards and adheres to international regulations with advanced technology and equipment for consistent production of liquid/lyophilized vials, prefilled syringes, and cartridges. Lupin is committed to expanding its portfolio and capabilities to meet the under-served demand for injectable drugs and to continue to serve patients around the world.
Glycopyrrolate Injection USP, 0.2 mg/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 (RLD Robinul) had estimated annual sales of USD 39 million in the U.S. (IQVIA MAT December 2022).
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