Lupin receives approval from USFDA for Glycopyrrolate Injection USP

Lupin Limited today announced that it has received approval from the United States Food and Drug Administration (U.S.FDA) for its abbreviated new drug application for Glycopyrrolate Injection USP, via an exchange filing.

It is 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.

“We are committed to building a strong injectable business as part of our growth strategy,” said Vinita Gupta, CEO, Lupin.

“With the approval of our Nagpur facility, we can now fast-track our injectable portfolio rollout and build upon our R&D capabilities in complex products. The approval for Glycopyrrolate clears the path for more internally manufactured injectable products.”

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).