News Par Views | Wockhardt US FDA से Zaynich की NDA अर्जी मंजूर कब तक मिल सकती है Zaynich को ...
Questions asked in this interview
5
2:20Please explain if there is really a high demand for this drug in the US right now, and does fast-track mean approval could come sooner than the six to eight months you mentioned?
4:57What revenue and profit expectations can you have?
6:31What other products are in the pipeline, and what new and big things can we expect from Wockhardt?
7:57Do you plan any more fundraising, or do you need it at this time?
8:19Is your company also preparing to move toward any weight-loss-related or similar new drugs?
Let's meet the country's leading pharma company, Wockhardt. Founded in 1967, it is a research-based global pharma and biotech company, and the only Indian pharma company to receive QIDP status from the US FDA for six antibacterial research projects. It has research facilities in India, the US, and the UK. Joining us is a very special guest, Habil Khorakiwala, Founder Chairman and Group CEO of Wockhardt Limited, a highly respected figure in the pharma industry. He studied at Purdue University and Harvard Business School. Additionally, in the past 125 years, no one except a US citizen has been awarded a doctorate by a major university, but Khorakiwala has. Good morning, sir. Welcome. Thank you for your time. First, there is big news about your company from two days ago. I'd like to get your opinion on it. The US FDA has approved your antibiotic drug Jenic for NDA filing. Please explain what developments have occurred for Wockhardt and what this means.
Good morning to all the viewers. The FDA has accepted our application for Jenic, which we filed in September. This means they will process it, and since our filing was correct, I expect product approval in six to eight months. But the most important thing is that this is the first time for Wockhardt and for India that an application for a new drug has been accepted by the FDA. That is a very proud moment for all of us.
Sir, I understand that the US FDA not only accepted it but also asked for fast-track approval. Please explain if there is really a high demand for this drug in the US right now, and does fast-track mean approval could come sooner than the six to eight months you mentioned?
This fast-track status is given because there is an unmet need for this type of drug in the US today; there is no current treatment. So it has been placed on fast track. You might be surprised that even during the lockdown, the FDA was in dialogue with us for clarifications on other things. Six to eight months is the minimum time; normally it takes 12 months for a new product. So this is what fast track means: there is an unmet medical need, and they want it to reach the market as quickly as possible.
Okay, Dr. Khorakiwala, please explain how long it took Wockhardt to develop this drug, and if you can give an idea of the investment the company made in this development.
Our antibiotic drug discovery program is 25-27 years old, and we started this specific drug in 2011. So far, we have invested the equivalent of $700 million in drug discovery. An international big pharma company would need $10-15 billion. Also, we have discovered six drugs so far, and we are the most successful R&D company in antibiotics in the world today. That is a very important thing from India's point of view. This first step in innovation is for Wockhardt and even more for India, showing that new innovation can happen here too.
Dr. Khorakiwala, experts tracking your company in the market believe this drug approval could be a game-changer for Wockhardt. Please explain its potential: how big is the market in the US, other countries, and India, and what benefit could Wockhardt get upon approval? What revenue and profit expectations can you have?
Looking at the global potential, we told investors it is $7 billion. But wherever we market in the world, we expect peak sales to be about $1-2 billion. Our patent in the US lasts until 2037. Also importantly, this is a life-saving medicine. In India, we have already saved 70 lives, and there is still high demand. We cannot supply yet because the drug is not approved in India. When it is approved, we will supply here too. I expect the drug controller to approve it in five to six months, so we should be in the Indian market and save many lives.
8 more exchanges in this transcript
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Khorakiwala, H. (2025, December 7). Wockhardt’s Weight Loss Drug Strategy Revealed | Group CEO Habil Khorakiwala [Interview transcript]. Zee Business. CEOInterviews.AI. https://ceointerviews.ai/interview/550280/
MLA
Habil Khorakiwala. "Wockhardt’s Weight Loss Drug Strategy Revealed | Group CEO Habil Khorakiwala." Zee Business, 7 Dec. 2025. Transcript, CEOInterviews.AI, https://ceointerviews.ai/interview/550280/.
BibTeX
@misc{khorakiwala2025_550280,
author = {Habil Khorakiwala},
title = {Wockhardt’s Weight Loss Drug Strategy Revealed | Group CEO Habil Khorakiwala},
howpublished = {Interview transcript, Zee Business. CEOInterviews.AI},
year = {2025},
month = {dec},
url = {https://ceointerviews.ai/interview/550280/},
note = {Speaker-attributed transcript with timestamps}
}
