Multi-drug resistant infections medicine 'Zaynich' to get USFDA approval next year: Wockhardt Chairman

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-04-14 10:19 GMT   |   Update On 2025-04-14 10:19 GMT
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Dubai: Zaynich, a multi-drug resistant infections medicine, is set to receive the US Food and Drug Administration (USFDA) approval in 2026, Habil Khorakiwala, Chairman of Indian pharmaceutical company Wockhardt said.

Zaynich is a novel antibiotic developed to target multi-drug-resistant Gram-negative infections.

"We started our research programme 25 years ago. And today we have six drugs for multi-drug resistance," the Chairman of the Indian pharmaceutical company told on the sidelines of the ongoing 'Global Justice- Love and Peace Summit' in Dubai.
"We are the most successful research company, in the world, in antibiotic research today.... I think our contribution is not only making the drug affordable in India but saving many, many lives, and we will be marketing these products in the USA and Europe, and we hope that our main drug 'Zaynich' will get USFDA approval sometime next year," Habil Khorakiwala said.
Reportedly, Wockhardt discovered a 100 per cent clinical cure rate among 30 critically ill patients treated with Zaynich -- a combination of Zidebactam and Cefepime -- for life-threatening, drug-resistant infections.
Habil Khorakiwala, talking to ANI on Friday, also indicated that the US administration's imposition of tariffs on pharmaceutical products would be counterproductive for Americans.
The US now imposes a 10 per cent baseline tariff on all imported goods.
The remaining reciprocal tariffs imposed by the US on dozens of partner countries have been paused for 90 days, except for China. Faced with reciprocal tariffs, as many as 75 partner countries are actively negotiating a trade deal with the US.
Wockhardt Chairman told ANI that India supplies 40 per cent of prescription drugs to the United States.
"And over the years, we (India) made so much contribution in making products available at a reasonable price (in the US)," said Khorakiwala. "The whole approach would be counterproductive for the American people, mainly because when it is not easier to switch, for medicine, because the approval process by USFDA takes several years," the pharma company boss said.
Against that backdrop, Habil Khorakiwala said he believes that whatever tariff comes on pharma, if at all, a significant part of it will be transferred to the American healthcare system.
On Tuesday night (local time), US President Donald Trump announced that tariffs on the pharma sector were coming soon. The sector has so far been exempted from the tariffs.
Further, Khorakiwala said the cost of putting a pharma facility in the US would be significantly higher.
"And the cost advantage which is available (at present), would be completely reduced. India's success over the years, last 20-25 years in the US is mainly because we could meet the US requirement with the quality they want and at the price which is globally competitive, and that is our Indian strength," Khorakiwala added.
On top of the manufacturing cost, Khorakiwala asserted that the research cost in the US is in multiples to that in India.
"There are two aspects of costs. One is the manufacturing cost. It is about 3 to 4 times more. Second, more important in our industry is the research cost, and that is 10 to 20 times more," he argued.
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