Global pharma major Lupin has announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Glycopyrrolate Injection USP, a generic equivalent of Robinul Injection, 0.2 mg/mL of Hikma Pharmaceuticals, US.
The product marks the first approval from Lupin’s new injectable facility in Nagpur, India, the company said in a statement. The drug is used in combination with other medications to treat ulcers in adults and children of 12 years of age and older.
“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.”
The 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 Robinu) had estimated an annual sales of US$39 million in the US. (IQVIA MAT December 2022).
Lupin is a transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.