The company announced in an exchange filing made after trading hours on Monday that it had received final approval from the US Food and Drug Administration (US FDA) 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 manufactured at a contract manufacturing facility. Apremilast Tablets, 10 mg, 20 mg, and 30 mg, are the generic equivalents of Celgene’s reference listed drug (RLD) OTEZLA.
Apremilast is a prescription medication used to treat certain types of psoriasis and psoriatic arthritis. It could also help with other immune-related inflammatory diseases. The US market for Apremilast Tablets, 10 mg, 20 mg, and 30 mg, according to IQVIA MAT Q4 2022 data, is approximately $3.55 billion.
Shilpa Medicare is a global brand that manufactures and supplies low-cost API and formulations in various regulated markets around the world. In Q3 FY23, the company reported a consolidated net loss of Rs 6.62 crore, compared to a net profit of Rs 9.57 crore in Q3 FY22. During the quarter, net sales fell 3.6% year on year to Rs 262.50 crore.