Shilpa Medicare Psoriatic arthritis drug Apremilast gets USFDA okay

Karnataka: Shilpa Medicare has recently announced that the Company has received final approval from the U.S Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), Apremilast Tablets, 10 mg, 20 mg, and 30 mg.

The medicine is indicated for the treatment of adult patients with active psoriatic arthritis. Psoriatic arthritis is a long-term inflammatory arthritis. It occurs in individuals affected by the autoimmune disease psoriasis. Swelling and pain in joints are commonly present in 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

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Shilpa Medicare Limited started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

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