Lupin gets US FDA nod for Vitamin B12 nasal spray

Lupin recorded PAT of Rs 247 crore in Q4FY23

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26 Aug, 2025 12:21

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Indian pharmaceutical firm Lupin on July 3 said it received approval from the United States Food and Drug Administration (US FDA) for its Cyanocobalamin nasal spray, used in maintaining normal vitamin B12 blood levels in pernicious anaemia patients.

The American drug regulator has given its nod to the "company’s
Abbreviated New Drug Application for Cyanocobalamin Nasal Spray, 500 mcg/spray", Lupin told stock exchanges after market hours.

The nasal spray is a "generic equivalent of Nascobal nasal spray, 500 mcg/spray of Par Pharmaceutical Inc", it added.

The Cyanocobalamin nasal spray, apart from being administered in cases of pernicious anaemia to maintain healthy Vitamin B12 blood levels, is also given to adults who require higher amounts of Vitamin B12, a Mayo Clinic report says.

The medicine, which can only be sold on prescription, is also used in the treatment of Vitamin B12 deficiency caused by certain medications, malabsorption-related issues or food limitations, the report added.

Lupin, in a release, said the medicine will be manufactured at its Somerset-based facility in the US. "Cyanocobalamin Nasal Spray (RLD Nascobal®) had estimated annual sales of USD 69 million in the US," it said.

The approval comes around 10 days after the FDA issued its much-awaited nod for Lupin's generic version of Boehringer Ingelheim's Spiriva Handihaler (Spiriva), a drug used as bronchial asthma inhaler.

In the quarter ending March 2023, Lupin reported a net profit of Rs 236 crore, as compared to a net loss of Rs 344 crore in the year-ago period. Revenue from operations came in at Rs 4,330.30 crore, jumping 12 percent as against Rs 3,864.50 crore in Q4FY22.

On July 3, Lupin's shares closed at Rs 892.75 on the BSE, 1.10 percent lower from the previous close.