Wockhardt Limited has filed its mandatory regulatory certificate under SEBI (Depositories and Participants) Regulations, 2018 for the quarter ended 31st March 2026. The pharmaceutical company submitted the required documentation to both BSE Limited and National Stock Exchange of India Limited on 9th April 2026.

Regulatory Compliance Filing

The certificate was submitted pursuant to Regulation 74(5) of SEBI (Depositories and Participants) Regulations, 2018. Company Secretary Rashmi Mamtura signed the filing letter, which was addressed to both major stock exchanges where the company's shares are listed.

Certificate from Registrar and Transfer Agent

MUFG Intime India Private Limited, formerly Link Intime India Private Limited, served as the Registrar and Share Transfer Agent for this certification. The company confirmed proper handling of securities received from depository participants for dematerialisation during the specified quarter.

The certificate confirms that:

• Securities received for dematerialisation were properly confirmed to depositories
• All securities were listed on stock exchanges where existing securities are already listed
• Security certificates were mutilated and cancelled after verification
• Depository names were substituted in the register of members within prescribed timelines

Administrative Details

The filing included copies sent to both National Securities Depository Ltd. and Central Depository Services (India) Limited, the two main depositories in India. This ensures comprehensive compliance across all relevant regulatory bodies.

This routine regulatory filing demonstrates Wockhardt's ongoing compliance with securities market regulations and proper maintenance of shareholder records through authorised market infrastructure institutions.

Wockhardt Limited has announced a significant regulatory milestone for its novel antibiotic Zaynich (Zidebactam/Cefepime), which has received a favourable recommendation from the Central Drugs Standard Control Organization's Subject Expert Committee for marketing permission to treat Gram-negative infections. This positive regulatory opinion represents a crucial step toward final approval by the Drugs Controller General of India.

Comprehensive Clinical Development Program

The favourable recommendation follows an extensive review of the product dossier encompassing robust clinical and non-clinical data. The evaluation included comprehensive evidence from nine Phase 1 studies, a multi-indication Phase 2 study in meropenem-resistant infections, a global Phase 3 study in complicated urinary tract infections and acute pyelonephritis, and data from 85 compassionate-use cases.

Novel Mechanism and Development Timeline

Developed over 15 years by a team of 150+ scientists across 10 disciplines, Zaynich features a novel β-lactam enhancer-based mechanism. This innovative approach enables potentially unprecedented coverage of multi-drug resistant and extensively drug-resistant Gram-negative pathogens prevalent in India. The antibiotic represents one of the most comprehensively evaluated antibiotics globally in recent years, supported by over 100 national and international publications and presentations, with the majority contributed by independent experts.

Clinical Efficacy Results

In the Phase 3 study, Zidebactam/Cefepime demonstrated superiority over meropenem in combined clinical and microbiological cure rates, highlighting the impact of its novel mechanism of action. The drug showed remarkable efficacy with over 97.00% clinical success in a real-world study of meropenem-resistant infections conducted across 15 leading tertiary care hospitals in India.

Regulatory Recognition and Global Applications

Zaynich also demonstrated strong efficacy in 85 extensively drug-resistant Gram-negative infection cases treated under compassionate use across India, US, Malaysia and France, where no safe and efficacious alternatives were available. This highlights the global unmet medical need in treating resistant Gram-negative infections and Zaynich's potential to address this critical healthcare challenge.

The Clinical and Laboratory Standards Institute has granted Zidebactam/Cefepime an investigational susceptible breakpoint of 64 mg/L, indicating its potential to comprehensively cover clinically important extensively drug-resistant Gram-negative pathogens in critically ill patients. The company has already submitted a New Drug Application in the United States and a Marketing Authorisation Application in the European Union, both currently in advanced stages of regulatory review.