Lupin Cyanocobalamin Nasal Spray gets U.S. FDA approval

Lupin Boosts Indian Therapy Portfolio with Menarini Brand Acquisitions

Lupin Cyanocobalamin Nasal Spray gets U.S. FDA approval

Leading global pharmaceutical company, Lupin Limited (Lupin), has recently announced that its Abbreviated New Drug Application for Cyanocobalamin Nasal Spray has received approval from the United States Food and Drug Administration (FDA). This nasal spray, which contains 500 mcg/spray of Cyanocobalamin (equivalent to Nascobal® Nasal Spray by Par Pharmaceutical, Inc.), will be produced at Lupin’s state-of-the-art manufacturing facility in Somerset, United States.

The approval of Lupin’s Cyanocobalamin Nasal Spray is a significant milestone, as the product is a generic equivalent of RLD Nascobal®, which has been generating an estimated annual revenue of USD 69 million in the U.S. market as of March 2023, according to IQVIA.

On the Bombay Stock Exchange (BSE), Lupin Limited’s shares closed at Rs. 892.45, slightly lower than the previous day’s closing price of Rs. 902.70. Throughout the day, a total of 31,180 shares were traded across 1,371 transactions.

About Lupin:

Lupin Limited, headquartered in Mumbai, is an Indian multinational pharmaceutical company with a strong global presence and a significant revenue share in the generic pharmaceutical industry. The company’s primary therapeutic areas of interest comprise paediatrics, cardiovascular diseases, anti-infectives, diabetology, asthma, and anti-tuberculosis drugs.

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