Lupin gets USFDA nod for Glycopyrrolate Injection USP

The drug major has received US Food and Drug Administration (USFDA) approval for its abbreviated new drug application (ANDA) for Glycopyrrolate Injection, USP.

The said drug is used in combination with other medications to treat ulcers in adults and children of 12 years of age and older. It 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. Lupin's 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.

Glycopyrrolate Injection USP (RLD Robinul) had estimated annual sales of $ 39 million in the U.S. (IQVIA MAT December 2022).

Vinita Gupta, chief executive officer, Lupin, said, 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.

Lupin is an innovation led Transnational Pharmaceutical Company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

On consolidated basis the company reported net profit of Rs 129.73 crore in Q2 FY23 as against net loss of Rs 2,098.04 crore in Q2 FY22. Net sales rose 2.2% to Rs 4,091.16 crore in Q2 FY23 as compared to Rs 4,003.42 crore in Q2 FY22.

The scrip rose 0.69% to Rs 780.60 on the BSE.

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