The US Food and Drug Administration (USFDA) has given Zydus Lifesciences permission to produce a generic version of Enzalutamide capsules (40 mg), a medication used to treat metastatic castration-resistant prostate cancer. As an androgen receptor inhibitor, enzalutamide prevents the action of androgens, or male hormones, which have the potential to encourage the growth of prostate cancer cells. The medicine will be produced at Zydus’s production location in Moraiya, Ahmedabad. Zydus has now earned 400 approvals from the USFDA since the start of its abbreviated new drug application (ANDA) filing process in 2003–2004, and this clearance represents another significant milestone for the company.
Enzalutamide capsules (40 mg) had yearly sales of USD 869.4 million in the US, according to IQVIA data for July 2024. With this permission, Zydus may now join this sizable market, which helps US patients with prostate cancer have access to an affordable generic substitute.
In another development, Biocon, another significant player in the pharmaceutical business, said that the USFDA had issued four observations during a surveillance examination of its Active Pharmaceutical Ingredient (API) facility in Bengaluru. The period of the examination was September 23, 2024–September 27, 2024. The business promised to respond to these observations in the allotted period. Additionally, Biocon stated that it does not believe these observations will have a significant effect on its business.
The changes show how Indian pharmaceutical businesses are still committed to growing their product lines in the US market, especially by producing generics and adhering to international regulatory requirements. The permission of Zydus to manufacture Enzalutamide capsules expands the company’s oncology offering and advances the overarching objective of lowering the cost and increasing accessibility to essential cancer therapies. In the meantime, Biocon’s cooperation with regulatory bodies like the USFDA demonstrates its dedication to upholding high standards of quality in its manufacturing facilities.
With an emphasis on providing reasonably priced and superior pharmaceuticals to global markets, Zydus and Biocon both make substantial contributions to India’s pharmaceutical exports. Key components of their growth strategy include regulatory clearances such as Zydus’s and adherence to quality standards as demonstrated by Biocon’s response to USFDA remarks. These methods help ensure that businesses remain competitive competitors in the highly regulated US pharmaceutical market while addressing the healthcare demands of patients abroad.
SOURCE :
BUSINESS STANDARD
