Zydus Cadila gets USFDA nod for Apremilast Tablets

On Friday, Zydus Cadila’s US subsidiary, Zydus Pharmaceuticals (USA), received final approval from the United States Food and Drug Administration (USFDA) to market Apremilast Tablets in the strengths of 10 mg, 20 mg, 30 mg.

Apremilast Tablets, 10 mg, 20 mg and 30 mg is the generic version of Otezla Tablets, 10 mg, 20 mg and 30 mg, of US-based Amgen Incorporation. The drug is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. The Otezla Tablets market achieved annual sales of approximately $2.7 billion. 

Zydus Cadila will manufacture this drug at the group’s formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 323 approvals and has filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 23000 people worldwide and is working to create healthier communities globally. 

At 1.20 pm on Friday, the stock of Cadila Healthcare Limited was trading at Rs 559.50, down by 1.31 per cent or Rs 7.40 per share, against a 0.31 per cent gain in the benchmark index. 

The 52-week high of the company was recorded at Rs 673.70, while its 52-week low is Rs 373.95 on BSE.