Lupin bags USFDA nod to market generic product in US market

Drug maker Lupin on Thursday said it has received approval from the US health regulator to market a generic medication, used before a surgery to decrease the volume of secretions from mouth, lungs and stomach, in the American market.

The company has received approval from the US Food and Drug Administration (USFDA) for Glycopyrrolate Injection, a generic equivalent of Hikma Pharmaceuticals’ Robinul Injection, the Mumbai-based drug maker said in a statement.

The product marks the first approval from the company’s new injectable facility in Nagpur, it added.

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

With the approval of the product from the Nagpur facility, the company can now fast-track its injectable portfolio rollout and build on R&D capabilities in complex products, she added.

The approval for Glycopyrrolate clears the path for more internally manufactured injectable products, Gupta stated.

As per IQVIA MAT data, 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 had estimated annual sales of USD 39 million in the US.

Shares of the company were trading 0.17 percent up at Rs 776.60 apiece on the BSE.