Shilpa Medicare is among the top three gainers on the BSE since the opening bell today; the stock, which had closed yesterday at Rs.233.20, opened today morning at Rs.246 and rose to an intraday high at Rs.259.40. Volumes on the counter have more than doubled.

Its 52-week high is at Rs.503.05 and low is at Rs.222.40.

The reason for this sudden interest in the stock? It announced yesterday late evening that it has received the US FDA final approval for its ANDA, Apremilast Tablets, 10 mg, 20 mg, and 30 mg for the treatment of adult patients with active psoriatic arthritis.

The product is executed from a contract manufacturing site.

Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.

According to IQVIA MAT Q4 2022 data, the US market for Apremilast Tablets, 10 mg, 20 mg, and 30 mg is approximately US $ 3.55 Billion.

This is welcome news as exactly a month ago, it unit in Hyderabad, Telangana had received two minor observations, related to improvements in existing procedures and are addressable.