Lupin bags USFDA approval for Glycopyrrolate Injection

Lupin Limited today announced that the United States Food and Drug Administration (USFDA) has approved its Abbreviated New Drug Application for Glycopyrrolate Injection USP, a generic equivalent of Hikma Pharmaceuticals USA Inc.'s Robinul Injection, 0.2 mg/mL. 

Lupin's new injectable facility in Nagpur, India, has received its first product approval.

Lupin's cutting-edge injectable plant boasts the highest quality standards and strictly follows international norms, equipped with state-of-the-art technology and machinery for producing top-notch liquid/lyophilized vials, prefilled syringes, and cartridges with consistency. 

Lupin remains dedicated to growing its offerings and capacities to fulfill the unmet need for injectable medications and to continue providing care to patients globally.

'As part of our growth plan, we are resolute in fortifying our injectable operations,' said Vinita Gupta, CEO of Lupin. 'Thanks to the approval of our Nagpur facility, we can accelerate the launch of our injectable portfolio and enhance our R&D in complicated products. The approval of Glycopyrrolate paves the way for a greater number of in-house produced injectable offerings.'

Glycopyrrolate Injection single-dose vials Multiple-Dose Vials (RLD Robinul) had annual sales of USD 39 million in the United States as per IQVIA MAT December 2022.

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