USFDA nod to Lupin Glycopyrrolate Injection

Mumbai: Global pharma major Lupin Limited today announced that the company has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Glycopyrrolate Injection USP.

The product 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.

“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.”  

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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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