US regulatory approval of Wockhardt’s homegrown antibiotic, designed to tackle some of the world's most drug-resistant superbugs, marks one of the most significant drug discovery successes by an Indian pharmaceutical company.

The US green light for Zaynich, an intravenous antibiotic targeting highly resistant gram-negative bacteria, comes as doctors worldwide struggle against infections that are becoming increasingly hard to treat..

The breakthrough is the culmination of a nearly 30-year gamble by Wockhardt chairman Habil Khorakiwala, who bet that Indian scientists could discover entirely new medicines rather than simply manufacture cheaper copies of drugs developed overseas.

"The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens," Khorakiwala says.

Zaynich combines cefepime, an established antibiotic, with zidebactam, a new molecule discovered by Wockhardt, and is designed to fight highly resistant bacteria that can cause bloodstream infections, pneumonia, kidney infections and other life-threatening illnesses.

The drug has now secured approval from both the US Food and Drug Administration and India's Central Drugs Standard Control Organisation, with a European application still under review.

Its approval places Wockhardt among a small group of companies globally developing new weapons against antimicrobial resistance, one of the most serious threats facing modern medicine.

Yet the achievement is remarkable not only because of the science involved, but because the programme survived one of the most dramatic corporate crises in India's pharmaceutical industry.

In 2009, Wockhardt appeared to be on the brink.

The company defaulted on Rs 473 crore of foreign currency convertible bonds raised during an international expansion drive. Bondholders sought to wind up the company in the Bombay High Court, while US regulators identified compliance problems at manufacturing plants, crippling its American business.

Investors fled. The share price collapsed. Rival drugmakers surged ahead.

Khorakiwala responded by dismantling much of the empire he had spent decades building.

Wockhardt sold 10 hospitals to Fortis for more than Rs 900 crore. It later sold its nutrition business to Danone and disposed of factories and pharmaceutical brands to Dr Reddy's Laboratories in a deal worth Rs 1,850 crore.

But one operation remained largely untouched throughout the crisis: the drug-discovery division.

"The philosophy was that if you enter new chemical entity research, you must commit for 25 to 30 years," Khorakiwala says.

That decision now appears to be paying off. "Wockhardt has transformed into an innovation-led pharmaceutical company with a strong pipeline of novel antibiotics, highlighted by the US Federal Drug Administration's approval of Zaynich," says Abhijeet Porwal, analyst at Deven Choksey Research.

The company expects commercial sales of Zaynich to begin contributing meaningfully from financial year 2028.

"The US launch will take about six to eight months and India around five to six months. Financial year 2029 will be the zoom year," Khorakiwala told Moneycontrol.

The potential market is substantial.

Analysts estimate drugs targeting resistant gram-negative bacteria represent a global market worth around $9 billion. New antibiotics introduced in the United States during the past decade have often cost between $10,000 and $15,000 for a typical treatment course.

But the antibiotic programme extends far beyond Zaynich.

Wockhardt has assembled one of India's most ambitious anti-infective pipelines, targeting a range of drug-resistant organisms including MRSA, ESBL-producing bacteria and carbapenem-resistant pathogens that can evade some of medicine's last lines of defence.

For doctors confronting infections that no longer respond to conventional treatments, the company's portfolio offers a growing number of options.

Emrok and its oral companion Emrok O were the first new chemical entities to emerge from Wockhardt's discovery programme. Developed over 12 years, they target serious gram-positive infections including MRSA, one of the world's most feared hospital superbugs.

A key advantage is that patients can begin treatment intravenously and later switch to tablets, potentially shortening hospital stays.

Miqnaf, approved in India after five years of development, tackles community-acquired bacterial pneumonia. It is the first new medicine in its class in more than three decades and requires only a three-day treatment course.

Foviscu was developed to combat ESBL-producing bacteria that can neutralise many commonly used antibiotics. Its broader purpose is to reduce dependence on carbapenems, among the most valuable antibiotics remaining in doctors' arsenals.

Odrate, meanwhile, targets carbapenem-resistant Enterobacterales and could eventually allow more patients to receive powerful antibiotic treatment outside hospital through once-daily dosing.

All six of Wockhardt's antibiotic candidates have received Qualified Infectious Disease Product designation from the US Food and Drug Administration, a status intended to accelerate development of urgently needed anti-infective medicines.

The programme reflects a bet that many larger pharmaceutical companies were unwilling to make.

For years, major drugmakers have steadily retreated from antibiotic research because the economics are notoriously unattractive. A successful diabetes or cholesterol medicine can generate revenue for decades. Antibiotics are typically used for days or weeks and, once approved, are often deliberately reserved to slow the emergence of resistance.

As much of the industry moved elsewhere, Khorakiwala saw an opportunity.

"Large pharma companies were vacating antibiotics and we saw an opportunity," he says. "We chose something where we could build leadership."

The company says it has invested at least $800 million in research programmes over the years, a substantial sum for an Indian drugmaker.

Wockhardt is now restructuring itself around those scientific ambitions. It has announced plans to exit its loss-making US generics business and focus on two areas where it believes it can compete globally: novel antibiotics and advanced biological insulin products.

The shift has begun to attract investors. Wockhardt's shares have more than doubled over the past year as the market started assigning greater value to its research pipeline.

Khorakiwala believes the current crop of medicines is only the beginning.

"We will have every two years, three years, a new drug coming out for the next 10 to 15 years," he says. "I have another two or three drugs which we have not even announced, which are in early stages."