Wockhardt has filed for approval of its promising novel antibiotic Zaynich (WCK 5222 – Zidebactam/Cefepime), with the Drug Controller General of India, the Mumbai-based drugmaker said.
Outlining regulatory timelines, the company said, it expected to get an approval and launch Zaynich in India, in the second half (H2) of the financial year 2025-26. Separately, in the US, the company completed its pre-NDA (New Drug Application) meeting with the United States Food and Drug Administration in May, the company said, and expected to file for regulatory approval in the US in the second quarter (Q2) FY 25-26, with a potential launch in FY26- 27, it added.
Regulatory filings in Europe and other emerging markets would be in the second half of this financial year, the ₹3,033 crore-Wockhardt said, sharing its growth plans on completing 25 years of being listed on the NSE. The addressable potential in India, for this product, was estimated at ₹17,000 crore, while the opportunity in the US and Europe was pegged at about $7 billion, the company said.
Announcing its annual financial results recently, Wockhardt had said, “The combined efficacy of Zaynich is the highest ever recorded among recently approved novel antibiotics developed in more than a decade. ….Additionally, Zaynich was well-tolerated and showed a safety profile consistent with β-lactam class of antibiotics, comparable to meropenem.”
Further, it added, the novel antibiotic “had treated 51 patients, including three US patients, under compassionate use, after receiving approval from DCGI and US FDA. Use of Zaynich resulted in over 95 per cent cure and was found to be safe even when administered up to 95 days.”
Wockhardt has, meanwhile, launched antibiotic Miqnaf (nafithromycin), targeting respiratory tract infection, in India. This was an addressable opportunity of ₹10,800 crore, it said.
Diabetes plans
Pointing to its diabetes products, including insulin portfolio, Wockhardt said, the exit of Novo Nordisk from the human disposable insulin pens and cartridges opened an opportunity, as it was one of three companies addressing this segment. This could open a $157 million opportunity in the emerging markets, the company said.
Wockhardt said, it was “uniquely positioned” to address the diabetes segment, (with emerging markets holding an opportunity of $3 billion), given its end-to-end capabilities. The company added that it was doubling capacity over three years, and expected to grow by about 20-25 per cent.
Published on June 5, 2025