Lupin receives US regulator's approval for Cyanocobalamin nasal spray

Pharmaceutical firm Lupin on Monday announced that the United States Food and Drug Administration (USFDA) had approved its abbreviated new drug application for cyanocobalamin nasal spray.

Cyanocobalamin is a manufactured version of vitamin B12 used to prevent and treat vitamin B12 deficiency anaemia (low blood levels of this vitamin in the body).

Vitamin B12 deficiency anaemia usually occurs due to anaemia, low stomach acid due to swelling (inflammation) in the lining of the stomach (atrophic gastritis) or certain medicines or as a side effect of

gastric surgery.

The nasal spray manufactured by Lupin is a generic version of Nascobal nasal spray. The nasal spray will be made at the firm's Somerset facility in the US, the company said. According to IQVIA data, Cyanocobalamin nasal spray had estimated annual sales of $69 million in the US.

Last week, media reports emerged that Lupin is likely to demerge its active pharmaceutical ingredients (API) business as part of an internal restructuring exercise. API is the bulk drug ingredient that goes into making drug formulations. According to media reports, the pharma major is considering demerging its API business to unlock value.

Vinita Gupta, CEO, Lupin, said in the company’s fourth-quarter earnings call that the API business is recovering. Ramesh Swaminathan, executive director (ED) and Global chief financial officer (CFO), Lupin, said that in the fourth quarter, the API business has grown by 46.4 per cent year-on-year (YoY).