Kwality Pharmaceuticals Limited has received permission from the Central Drugs Standard Control Organization (CDSCO) to manufacture pilot batches of Pembroluzimab for preclinical studies. This approval represents a significant milestone in the company's biologics development journey.
The CDSCO approval followed a comprehensive review of the product's development data submitted by the Company's R&D team. Based on the evaluated data, the regulatory authority granted permission to proceed with pilot-scale manufacturing for the generation of preclinical batches. This approval marks the product's transition from the research and development stage to the Pre-Clinical stage.
The company states its strategic objective to be among the first wave of generic manufacturers to launch Pembroluzimab following the expiry of the reference product's patent. This ambition is contingent upon successful development and obtaining necessary regulatory approvals.