Shares of Zydus Lifesciences Ltd surged 3% on 19 March after the company received final approval from the USFDA for Apalutamide Tablets, 60 mg.
The company, in its regulatory filing, announced that they have secured final approval from the US Food and Drug Administration (USFDA) to produce 60 mg Erleada Tablets (Apalutamide Tablets). Apalutamide is an androgen receptor inhibitor that may be useful in treating patients with metastatic castration-sensitive prostate cancer. In its filing, the company added that these tablets will be produced at its Ahmedabad plant.
Earlier on 16 March, the company received final approval from the USFDA to manufacture 75 mg and 100 mg Eluxadoline tablets. Eluxadoline, a mu-opioid receptor agonist, is administered to adults to treat IBS-D or irritable bowel syndrome with diarrhoea.
On 14 March, the company said that the USFDA had conducted an inspection visit at the group’s API Unit 1, located in Ankleshwar, Gujarat. The inspection, which took place between 10 March and 14 March 2025, concluded without any observations.
On 12 March, the USFDA granted the business final approval to manufacture Methenamine Hippurate Tablets USP, 1 gram, which are advised for the prevention or suppression of recurrent UTIs where long-term treatment is believed to be necessary.
Additionally, Zynext Ventures USA LLC, the company’s venture capital arm, revealed that it had invested in Illexcor Therapeutics (Illexcor), a cutting-edge biopharmaceutical business creating next-generation oral medications for sickle cell disease (SCD).
At 11:33 am, the shares of Zydus Lifesciences were trading 1.04% higher at Rs 911.60 on NSE.
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