Shilpa Medicare gets tentative USFDA’s nod for Apremilast tablets

Shilpa Medicare has received tentative approval from the US health regulator for Apremilast tablets, used in the treatment of psoriatic arthritis. The newly approved product is a generic equivalent of reference listed drug (RLD) Otezla of Celgene.

The company has received tentative approval from US Food and Drug Administration for its abbreviated new drug application (ANDA) Apremilast tablets in the strengths of 10 mg, 20 mg, and 30 mg.

Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.