In an exchange filing made after trading hours on Monday, the company said that it has received U.S Food and Drug Administration (US FDA) final approval for its abbreviated new drug application (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.

Apremilast is a medication for the treatment of certain types of psoriasis and psoriatic arthritis. It may also be useful for other immune system-related inflammatory diseases. According to IQVIA MAT Q4 2022 data, the US market for Apremilast Tablets, 10 mg, 20 mg, and 30 mg is approximately $3.55 billion.

Shilpa Medicare is a global brand in manufacturing and supplying of affordable API and formulation globally in different regulated markets.

The company reported a consolidated net loss of 6.62 crore in Q3 FY23 as against a net profit of Rs 9.57 crore posted in Q3 FY22. Net sales declined 3.6% year on year to Rs 262.50 crore during the quarter.