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Shilpa Medicare gets USFDA’s final nod for Apremilast Tablets

11 Apr 2023 Evaluate

Shilpa Medicare has received U.S Food and Drug Administration (USFDA) 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. The US market for Apremilast Tablets, 10 mg, 20 mg, and 30 mg is around $3.55 billion.

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.

Peers
Company Name CMP
Sun Pharma. Inds. 1853.50
Dr. Reddys Labs. 1202.80
Cipla 1397.20
Lupin 2090.00
Zydus Lifesciences 1202.00
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