Zydus Lifesciences Gets FDA Approval To Manufacture Apalutamide Tablets

Zydus Lifesciences Ltd. has received final nod from the United States Food and Drug Administration to manufacture 60 mg Apalutamide tablets, according to an exchange filing on Tuesday.

Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer. The tablets will be produced at the company's manufacturing site in Ahmedabad, it said.

Apalutamide tablets had annual sales of nearly $1.1 billion in the US. The group has 420 approvals and so far filed 483 abbreviated new drug applications since the commencement of the filing process in fiscal 2003–04.

Earlier on March 11, the company announced that it would acquire French orthopedics company Amplitude Surgical SA for €300 million or around Rs 2,851 crore. The board approved a put open agreement, share purchase agreement and other agreements to acquire 85.6% stake in Amplitude Surgical for €6.25 per equity share, aggregating to €256.8 million.

Shares of Zydus Lifesciences closed 1.06% higher at Rs 902.15 apiece on the NSE, compared to a 1.45% advance in the benchmark Nifty. The stock has fallen 8.99% in the last 12 months.

Seventeen out of the 33 analysts tracking the company have a 'buy' rating on the stock, 10 recommend 'hold' and six suggest 'sell', according to Bloomberg data. The average of 12-month analyst price targets implies a potential upside of 20.5%.