“Very confident of positive outcome”: Habil Khorakiwala on USFDA acceptance of Wockhardt’s NDA for its novel antibiotic

Wockhardt

Habil Khorakiwala, the Chairman of Wockhardt Ltd., said he expects US approval for the novel antibiotic Zaynich by mid-2026.

“The review process may take six to eight months. We are very confident of positive outcome,” Khorakiwala told Moneycontrol on Monday.

Khorakiwala said the Mumbai-based drugmaker is already laying groundwork for commercialization, with options ranging from solo marketing to partnerships in the US.

“We have started commercialization work and are considering a number of options,” Khorakiwala said.

Wockhardt on Monday announced to stock exchanges that the US drug regulator accepted its novel antibiotic Zaynich New Drug Application (NDA) for review.  The USFDA takes 10 months for a standard review, but for Zaynich it will be six months as it is a priority review. USFDA in its review looks for data completeness and quality.

Khorakiwala added that the NDA is accepted when the application is "proper and full".

After the NDA is accepted, Khorakiwala said the process involves visiting manufacturing facilities, inspecting documents, and so on.

Khorakiwala said Zaynich is manufactured in Europe at USFDA-compliant facilities.

The USFDA’s nod would mark a historic milestone—the first-ever NDA acceptance for a new chemical entity from an Indian pharma company.

Zaynich, which showed a 20 percent higher cure rate over Meropenem in global Phase III trials, targets severe multi-drug resistant infections.

“If Zaynich gets an FDA nod, the market potential is substantial,” Khorakiwala said.

Wockhardt estimates a $7 billion opportunity globally and Rs 17,000 crore annually in India.

Wockhardt has also sought approval from India’s regulator and plans launches in Europe and emerging markets in the second half of FY26.

For Wockhardt, which spends Rs 200 crore annually on R&D and employs 145 scientists including 50 PhDs, the USFDA acceptance signals a new chapter in its 25-year pursuit of novel antibiotics.

If Zaynich gets an FDA nod, the market potential is substantial.

Wockhardt estimates an addressable pool of approximately 2 million patients globally in select markets.

In India alone, the company sees a market of around 1.1 million cases, translating to a potential business of Rs 17,000 crore annually. For the US and European markets, Zaynich offers a $7 billion opportunity, targeting roughly 371,000 carbapenem-resistant cases. China has another 657,000 patients.

Carbapenems are a class of antibiotic agents mostly used in treating severe bacterial infections.

Shares of Wockhardt rose 19.24 percent to close at Rs 1470.90 on BSE on Monday, while the benchmark Sensex declined 0.08 percent to 85,641.90 points.