Key Points:
- Wockhardt Zaynich antibiotic gets USFDA NDA acceptance, marking a milestone for an Indian-developed NCE.
- Wockhardt shares surge 19% on heavy trading volume.
- Company outlook strengthens with strong exports and biosimilar expansion.
Wockhardt shares gained 19 percent on the National Stock Exchange (NSE) on Dec. 1 after the company announced that the United States Food and Drug Administration (USFDA) accepted its New Drug Application (NDA) for Zaynich, a first-in-class antibiotic. The Wockhardt Zaynich antibiotic NDA acceptance pushed the stock to ₹1,472.70 in intraday trade, supported by unusually heavy volumes.
Strong market reaction
The share price rebounded 20 percent from the day’s low of ₹1,225.20 as trading volume rose more than tenfold. Combined transactions on the NSE and BSE reached 7.76 million shares by early afternoon. At the same time, the Nifty 50 index slipped 0.08 percent to 26,181.
Wockhardt said the NDA acceptance is a major milestone for the company and for India’s pharmaceutical sector. Filed on Sept. 30, the application marks the first time the USFDA has accepted an NDA for a New Chemical Entity (NCE) developed by an Indian drugmaker. This makes the Wockhardt Zaynich antibiotic an important step forward.
Significance of Zaynich submission
Zaynich uses a novel β-lactam enhancer mechanism designed to target drug-resistant Gram-negative pathogens. These pathogens contribute to extended hospital stays and high global mortality. Wockhardt said clinicians have used Wockhardt Zaynich antibiotic the antibiotic under compassionate-use provisions in India and the United States, demonstrating positive outcomes in critically ill patients.
According to the company, Zaynich is among the most extensively researched antibiotics in recent years. Wockhardt began its development program in 2011 and has since completed a broad package of non-clinical, clinical, and regulatory studies.
Company growth outlook
Wockhardt said the antibiotic aligns with its long-term focus on advanced anti-infective therapies. The company maintains established operations in regulated markets including the United Kingdom and Ireland, while also expanding its footprint in emerging markets.
Export markets contributed 77 percent of Wockhardt’s revenue in FY25, according to an assessment by ICRA. The company generated about 80 percent of its revenue from branded generics and generic formulations. Biosimilars accounted for 19 percent, while the remainder came from NCEs sold in India, including Emrok and Emrok O.
Expansion plans in biosimilars
Wockhardt aims to launch existing biosimilars in markets where it does not currently operate and introduce new biosimilars such as insulin glargine in established and emerging markets.
ICRA said in an August assessment that Wockhardt’s revenue outlook appears positive due to continued growth in its base business and expected expansion of biosimilar revenues. The agency said stable operating profit margins and healthy cash flows may strengthen the company’s debt coverage indicators, though these remain important areas to monitor.
With the USFDA now accepting the NDA for the Wockhardt Zaynich antibiotic, Wockhardt expects regulatory review progress to support its strategic plans and reinforce its position in global anti-infective innovation.
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