Regulatory progress: Wockhardt has submitted the drug for approval in India and will file with the US FDA by August 2025, aiming for a US market debut by late FY 26 and launching in Europe around FY 27 .

Licensing strategy: They’ve engaged merchant bankers to explore out‑licensing deals, yet are prepared for self‑commercialization in India—and potentially the US—depending on partner valuations .

Manufacturing plan: To avoid past FDA compliance issues, Wockhardt plans to outsource Western manufacturing to EU/US facilities while centralizing clinical and R&D operations .

Market potential: The antibiotic targets drug‑resistant gram‑negative infections with a global market projected at $9 billion—$7 billion in the US/EU and ₹17,000 crore (~$2 billion) in India

Sales impact: Zaynich is viewed as a major driver behind Wockhardt’s turnaround—its stock has more than doubled in the past 18 months

sources