ZYDUS LIFESCIENCES LIMITED

Zydus Lifesciences receives USFDA approval for generic Paliperidone extended-release tablets (1.5 mg, 3 mg, 6 mg, 9 mg) to treat schizophrenia, to be manufactured in Ahmedabad.

Quality Assurance issues at CARsgen Therapeutics, Berkeley Biologics, Zydus Lifesciences, TJA Health, Clinical Integrative Research Center of Atlanta, and Regenerative Processing Plant highlighted in FDA warning letters, including infestations, inadequate monitoring, cross-contamination, and protocol violations.

Zydus Lifesciences share price marginally lower despite USFDA tentative approval for Enzalutamide Tablets, 40 mg and 80 mg. The tablets treat castration-resistant and metastatic castration-sensitive prostate cancer, produced at Ahmedabad SEZ site. The group has 400 approvals and filed over 465 ANDAs since FY 2003-04. Additionally, the company received EIR report for its Pharmez, Ahmedabad facility and final approval for Enzalutamide Capsules, 40 mg.

Zydus Lifesciences received tentative approval from USFDA to manufacture Enzalutamide tablets (40 mg and 80 mg) for prostate cancer treatment at its Ahmedabad SEZ site. The drug had USD 1,417.2 million in annual sales in the US as per IQVIA MAT July 2024 data.

Zydus Lifesciences receives USFDA approval for Enzalutamide Capsules, 40 mg, to treat metastatic castration-resistant prostate cancer, produced at Moraiya, Ahmedabad. Annual U.S. sales for the drug were $869.4 mn (IQVIA MAT July 2024).

Zydus Lifesciences received USFDA approval for generic Enzalutamide capsules (40 mg), indicated for metastatic castration-resistant prostate cancer, with annual US sales of USD 869.4 million. Biocon's Bengaluru API facility received four observations from USFDA, with no foreseen business impact.

Zydus Lifesciences received USFDA approval for Enzalutamide Capsules, 40 mg, indicated for metastatic castration-resistant prostate cancer, with annual US sales of $869.4 million. The drug will be manufactured in Ahmedabad, adding to the group's 400 approvals and 465 ANDAs filed since FY 2003-04.

Indian pharma giants focus on quality over quantity, with complex product filings increasing. US generics sales show slight growth, and regulatory challenges ease. Nomura recommends Lupin for its upcoming launches and stable market shares, while noting setbacks. Sun Pharma's specialty segment growth slows, and Dr Reddy's faces market share declines. Cipla and Zydus Lifesciences show growth but face inspection and competition challenges.

India's pharmaceutical industry is rapidly advancing in cancer drug development, driven by rising cancer cases and government initiatives like GST reductions on cancer drugs. Key companies like Beta Drugs, Shilpa Medicare, Gland Pharma, Venus Remedies, Pfizer, and Zydus Lifesciences are leading in innovation and global expansion, making cancer-focused pharma stocks a compelling investment opportunity.

Zydus completes Phase II(a) study of NLRP3 inhibitor Usnoflast (ZYIL1) in ALS patients, showing reduction in neurofilaments and improvements in ALSFRS-R score and SVC. Plans for Phase 2b trial.