Wockhardt share price: Wockhardt share price extended its rally for the second straight session on Tuesday, December 2, rising 6.5% after the company announced a historic regulatory milestone for its novel antibiotic Zaynich. This surge comes after Monday’s sharp 19.21% jump, taking the two-day rally to nearly 27% and placing the pharma major firmly back in investor focus.
The company revealed in an exchange filing that the United States Food and Drug Administration (US FDA) has formally accepted its New Drug Application (NDA) for Zaynich—a first-of-its-kind achievement for any Indian pharmaceutical company.
“This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the US FDA,” Wockhardt said in its regulatory update.
This acceptance marks a major breakthrough not only for Wockhardt but for the entire Indian pharmaceutical industry, positioning India on the global innovation map.
What is Zaynich and why it matters
Zaynich is a combination therapy made up of Zidebactam, a β-lactam enhancer, and Cefepime, a fourth-generation cephalosporin. The drug is designed to address life-threatening multi-drug resistant (MDR) and extensively drug-resistant (XDR) bacterial infections, including high-risk pathogens such as Pseudomonas Aeruginosa, Acinetobacter Baumannii, and Carbapenem-resistant strains.
The company noted that Zaynich has already been granted Fast Track designation by the US FDA, underscoring its potential to meet urgent unmet medical needs. As part of this designation, the FDA will give priority to reviewing Zaynich’s NDA.
Wockhardt emphasized that this approval is the result of a decade-long global development journey. Since 2011, Zaynich has undergone extensive non-clinical and clinical evaluations, evolving into one of the most comprehensively studied antibiotic candidates worldwide.
“The FDA’s acceptance of the Zaynich NDA is a historic and proud moment for the organization and for India. It reaffirms our commitment to developing advanced anti-infective solutions for the world and demonstrates what Indian science and innovation can achieve on the global stage,” the company added in its statement.
Wockhardt share price performance
Wockhardt’s share price has seen sharp swings over the past year, reflecting a period of heightened volatility despite the recent breakout rally. The pharma stock had climbed to a 52-week high of ₹1,870.00 in July 2025 but struggled to sustain those levels, gradually coming under pressure. Earlier in the year, it had slipped to a 52-week low of ₹1,109.60 in February 2025, underscoring the wide trading range it has navigated.
On a yearly basis, the stock has managed to deliver only 5%, indicating a muted performance for long-term holders. Over the past six months, it has inched up by 3%, with a slightly stronger improvement of 6.5% recorded in the last three months. The momentum has picked up meaningfully in the most recent month, during which the stock jumped 17.5%, fuelled by renewed optimism after its regulatory achievements.
From a multi-year perspective, however, Wockhardt tells a very different story. Over the last five years, the company has delivered multibagger returns of 257%, highlighting its ability to generate substantial wealth during phases of sustained business and regulatory progress.
A milestone moment for Indian pharma
The acceptance of an NDA for an Indian-developed New Chemical Entity is a landmark achievement. It positions Wockhardt as a global innovator rather than just a generic manufacturer—an important evolution for India’s pharmaceutical sector.
Zaynich’s potential approval could open the door for India to play a larger role in global antibiotic innovation at a time when antimicrobial resistance (AMR) is a major worldwide concern.
With the FDA’s Fast Track status and a priority review ahead, investors are now closely watching the next steps in Zaynich’s regulatory journey, which could redefine Wockhardt’s growth trajectory and further strengthen India’s footprint in global drug innovation.
