Lupin receives US regulator’s approval for Cyanocobalamin nasal spray |

Pharmaceutical company Lupine announced Monday that the US Food and Drug Administration (USFDA) has approved its new Bypass Application for nasal spray drug cyanocobalamin.

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

Vitamin B12 deficiency anemia is usually caused by anemia, low stomach acid due to swelling (inflammation) of the lining of the stomach (atrophic gastritis), certain medications, or as a side effect of

Stomach surgery.

The nasal spray manufactured by Lupine is a generic version of the Nascobal nasal spray. The company said the nasal spray will be made at the company’s Somerset facility in the United States. According to IQVIA data, Cyanocobalamin nasal spray has estimated annual sales of $69 million in the United States.

Last week, media reports surfaced that Lubin is likely to break up its active pharmaceutical ingredients (API) business as part of an internal restructuring. API is the bulk pharmaceutical ingredient that goes into making drug formulations. According to media reports, the major pharmaceutical company is considering spinning off its API business to unlock value.

Lupine CEO Vinita Gupta said on the company’s fourth-quarter earnings call that the API business is recovering. Ramesh Swaminathan, Executive Director (ED) and Global Chief Financial Officer (CFO), Lubin, said that in the fourth quarter, the API business grew 46.4 percent year-on-year.