BSECompany Update1d ago · 24 Jul 2026, 10:06 am

Kwality Pharmaceuticals receives CDSCO Nod to Initiate Preclinical Pilot Batches of Pembroluzimab

Kwality Pharmaceuticals Ltd · 539997

✦ AI Summary▲ PositiveProduct Launch

Kwality Pharmaceuticals receives CDSCO approval to initiate preclinical pilot batches of Pembroluzimab, a significant milestone in its biologics development journey.

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Earnings Impact2/10
Growth Catalyst8/10
Governance Concern1/10
Regulatory Risk1/10
Balance Sheet Risk1/10
Liquidity Impact8/10
Market Sentiment8/10

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Kwality Pharmaceuticals Ltd - 539997 - Disclosure Under Regulation 30 Of SEBI LODR

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CIN No. L24232PB1983PL0005426 GST No. 03AAACK6458M1ZB Phone : 91-8558820862 (Accounts) D.L. No. 1800-0SP, 1804-B I.E. Code No. 1293001210 : 91-8558820863 (Admin.) : 91-9915743720 (Exports) KWALITY PHARMACEUTICALS LTD. M.D. Mobile: 91-9814071215, 9814052314 Regd. Office: 6th Mile Stone, Village Nag KaIan, Majitha Road, Amritsar - 143 601 (INDIA) E-mail : export@kwalitypharma.com Global Address: N: 31.713874, L: 74.930479 ramesh@kwalitypharma.com To Date: Date: 24 July 2026 The BSE Limited Department of Corporate Services, P.J. Towers, Dalai Street, Mumbai-400001 Subject: Kwality Pharmaceuticals Ltd receives CDSCO Nod to Initiate Preclinical Pilot Batches of Pembroluzimab Dear Sir/Madam, Kwality Pharmaceuticals Limited has achieved a significant milestone in its biologics development journey after receiving permission from the Central Drugs Standard Control Organization (CDSCO) to manufacture pilot batches of Pembroluzimab for preclinical studies. The approval follows a comprehensive review of the product's development data submitted by the Company's R&D team. Based on the data evaluated, CDSCO has granted permission to proceed with pilot-scale manufacturing for the generation of preclinical batches, marking the product's transition from the research and development stage to Pre-Clinical stage. KPL aims to be among the first wave of generic manufacturers to launch Pembroluzimab following the expiry of the reference product's patent, subject to successful development and the necessary regulatory approvals. For Kwality Pharm Ramesh Kumar Managing Director DIN: 00462656