BRIEF—First approval from Lupin's injectable facility in Nagpur

Indian drugmaker Lupin Limited says it has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for glycopyrrolate Injection USP, a generic equivalent of Robinul Injection, 0.2mg/mL of Hikma Pharmaceuticals.

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 chief executive Vinita Gupta commented: “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.”