StockWatch
·
Pharmaceuticals
Clinical Trial24 Jul 2026, 10:08 am

Kwality Pharma gets CDSCO nod for Pembroluzimab preclinical batches

AI Summary

Kwality Pharmaceuticals Limited has received approval from the Central Drugs Standard Control Organization (CDSCO) to manufacture pilot batches of Pembroluzimab for preclinical studies. This signifies a crucial step in the company's biologics development, moving the product from R&D to the preclinical stage. The company aims to be an early generic manufacturer of Pembroluzimab upon patent expiry of the reference product, contingent on successful development and regulatory approvals.

Key Highlights

  • CDSCO approval granted for preclinical pilot batches of Pembroluzimab.
  • Marks transition from R&D to preclinical stage for the drug.
  • KPL aims for early generic launch post-patent expiry.
  • Success is subject to further development and regulatory approvals.