Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Glycopyrrolate Injection USP, a generic equivalent of Robinul Injection, 0.2 mg/mL of Hikma Pharmaceuticals. The product marks the first approval from Lupin’s new injectable facility in Nagpur, India.
“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,” said Vinita Gupta, CEO, Lupin.
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 $39 million in the US (IQVIA MAT December 2022).
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