Overview

• Wockhardt has submitted its novel antibiotic Zaynich to the Drug Controller General of India and anticipates a domestic launch in the second half of FY25-26.
• The company completed a pre-NDA meeting with the US Food and Drug Administration in May and intends to file its New Drug Application in Q2 of FY25-26.
• Zaynich targets complicated gram-negative infections and is projected to address a ₹17,000 crore market in India alongside a $7 billion opportunity in the US and Europe.
• Global phase-3 trials showed Zaynich achieved a 20% higher composite cure rate compared with meropenem and compassionate use in 51 patients delivered over a 95% cure rate.
• Wockhardt plans regulatory filings for Europe and other emerging markets in the second half of the current financial year