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Lupin Shares Rose on USFDA Approval for Nasal Spray

The company are exclusive first-to-file for this product and are eligible for 180-day exclusivity.

On July 4, Lupin’s share price zoomed over 1% in the early trade as the company acknowledged approval from the United States Food and Drug Administration (USFDA) for nasal spray.


At 9:52 am, Lupin shares were up 0.7% at Rs 898.35 on the BSE. The stock is barely 1% away from its 52-week high of Rs 908.4. The stock has shone close to 40% in the past three months.


Lupin has acknowledged approval from the USFDA for its condensed new drug application for Cyanocobalamin Nasal Spray, 500 mcg/spray (One Spray per Device), a generic equivalent of Nascobal Nasal Spray, 500 mcg/spray of Par Pharmaceutical.


The product will be manufactured at Lupin’s Somerset unit in the US.


Cyanocobalamin Nasal Spray had projected annual sales of USD 69 million in the US, as per IQVIA MAT data of March 2023.
Last month, the firm unveiled Rufinamide Oral Suspension, 40 mg/mL, a generic equivalent of Banzel Oral Suspension, 40 mg/mL of Eisai Inc.

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