 "Zydus gets USFDA approval to produce its generic prostate cancer drug")
Zydus Lifesciences on Saturday said it has received approval from the US health regulator to produce generic prostate cancer treatment drug.
The company has received approval from the US Food and Drug Administration (USFDA) to manufacture Enzalutamide capsules (40 mg), it said in a regulatory filing.
Enzalutamide capsules are androgen receptor inhibitors indicated for the treatment of patients with metastatic castration-resistant prostate cancer.
The drug will be produced at the group's manufacturing site in Moraiya, Ahmedabad, Zydus said.
As per IQVIA MAT July 2024 data, Enzalutamide capsules (40 mg) had annual sales of USD 869.4 million in the US.
The group now has 400 approvals and has filed over 465 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.
Biocon gets 4 observations from USFDA for Bengaluru API facility
Biocon on Saturday said the US health regulator has issued four observations after inspecting its Bengaluru-based API (active pharmaceutical ingredient) facility.
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The US Food and Drug Administration (USFDA) conducted a surveillance inspection of the API facility (Site 2), located at Bengaluru from September 23- 27, 2024, the company said in a regulatory filing.
"Four observations were cited at the end of the inspection, which the company will be addressing within the stipulated time," it added.
The company does not foresee any impact on the business, Biocon said.