Lupin gets USFDA approval for Glycopyrrolate Injection, USP

Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Glycopyrrolate Injection USP, a generic equivalent of Robinul Injection, 0.2 mg/mL of Hikma Pharmaceuticals. 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. 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,” said Vinita Gupta, CEO, Lupin.

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 $39 million in the US (IQVIA MAT December 2022).