Zydus Lifesciences’ share price extended its gains for the third consecutive session on March 19, rising over 1% after the company received final approval from the US Food and Drug Administration (USFDA) for Apalutamide Tablets, 60 mg.
At 9:20 AM, Zydus Lifesciences was trading at ₹916.05, up ₹12.95 or 1.43% on the BSE.
The company has obtained the final approval of the USFDA to manufacture Apalutamide Tablets, 60 mg, the generic version of Erleada Tablets, 60 mg. The androgen receptor inhibitor, Apalutamide, is administered in the therapy for metastatic castration-sensitive prostate cancer (mCSPC). The company will produce the drug at its plant in Ahmedabad.
This isn’t the first significant USFDA approval for Zydus Lifesciences this month alone. On March 16, the firm received final approval for the manufacture of Eluxadoline Tablets in strengths of 75 mg and 100 mg, which are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
In addition, on March 14, the company confirmed that the USFDA visited its Ankleshwar, Gujarat, API Unit 1 on the dates March 10-14. The inspection concluded with NIL observations, which indicated full regulatory compliance.
On March 12, final USFDA approval has also been received by Zydus Lifesciences to produce Methenamine Hippurate Tablets USP (1 gram), which is a medication for the long-term prevention of frequently recurring urinary tract infections (UTIs).
Meanwhile, the company’s venture capital arm, Zynext Ventures USA LLC, invested in the biopharmaceutical company, Illexcor Therapeutics (Illexcor), which is developing new-generation oral therapies for sickle cell disease (SCD).
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Source: Moneycontrol.
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