Zydus Lifesciences on Thursday said its subsidiary has joined hands with the Netherlands-based Synthon BV to introduce a generic drug for the treatment of multiple sclerosis in the US market. Zydus Lifesciences Global FZE has entered into an exclusive licensing and supply agreement with Synthon BV for Ozanimod capsules (a generic version of ZEPOSIA) for the US market, the company said in a regulatory filing. Synthon has a pending abbreviated new drug application in the United States, seeking approval for Ozanimod Capsules, indicated for relapsing forms of multiple sclerosis.
Jagsonpal Pharma appoints Amrut Medhekar as CEO
Jagsonpal Pharma has appointed Amrut Medhekar as its new Chief Executive Officer. Medhekar brings extensive pharmaceutical industry experience from his previous roles at Akums Drugs and Pharmaceuticals and Wockhardt. This strategic appointment is expected to leverage Medhekar’s diverse background to enhance Jagsonpal Pharma’s operational efficiency, market opportunities, product innovation, and industry partnerships.
USFDA issues 5 observations at Biocon Biologics
The USFDA has completed a routine cGMP inspection at Biocon Biologics’ Drug Substance facility at Biocon Campus in Bengaluru, India. The inspection was held between August 26, 2025, and September 3, 2025, covering drug substance manufacturing units, analytical QC laboratories, microbiology laboratories, and warehouses. At the conclusion of the inspection, the USFDA issued a Form 483 with five observations. These observations are procedural in nature and do not pertain to data integrity, systemic non-compliance, or quality oversight.