Shares of Lupin witnessed a bullish start on the NSE, climbing 3 percent higher in the early trade on November 24. The spike came on the heels of the pharmaceutical company’s announcement of tentative approval from the United States Food and Drug Administration (USFDA) for a diabetes medication.
As of 9:57 am, the stock was trading at ₹1,221.75, reflecting a notable 1.94% increase. This positive momentum follows Lupin’s disclosure on November 23 regarding the USFDA’s tentative approval for its Abbreviated New Drug Application (ANDA). The approval pertains to Canagliflozin Tablets, positioning Lupin to market a generic equivalent of Janssen Pharmaceuticals, Inc’s Invokana Tablets. The approval was granted for manufacturing at Lupin’s Pithampur facility.
According to the official statement, Canagliflozin Tablets boast estimated annual sales of $561 million in the United States. This development marks a significant stride for Lupin in the diabetes medication market.
Adding to the list of approvals, Lupin also secured USFDA approval for its ANDA related to Bromfenac Ophthalmic Solution, 0.07 percent. This approval strategically positions Lupin as the exclusive first-to-file entity for the generic equivalent of Bausch & Lomb Inc’s Prolensa Ophthalmic Solution, 0.07 percent. This recognition not only validates Lupin’s pharmaceutical prowess but also makes the company eligible for a coveted 180-day exclusivity period.
The back-to-back approvals underscore Lupin’s commitment to expanding its presence in critical healthcare segments, consolidating its position as a key player in the pharmaceutical landscape.