Global pharma major Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Glycopyrrolate Injection USP, 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,” added Gupta. 

 

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

 

Lupin is an innovation-led 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.

 

The company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the US by prescription. The company invested 8.7% of its revenue in research and development in FY22.