India Pharma Outlook Team | Wednesday, 28 August 2024
Bharat Biotech announced that its oral cholera vaccine has successfully completed a late-stage trial and is preparing for a global launch, with plans to produce up to 200 million doses annually. The vaccine, named Hillchol, has received approval from India's drug regulator and Bharat Biotech will seek pre-qualification from the World Health Organization (WHO) to supply major buyers like UNICEF.
The company aims to address the cholera crisis in Africa initially and is open to allowing African countries to procure the drug substance and handle final manufacturing locally if needed. Production will commence at Bharat Biotech's Hyderabad facility, which has a capacity of 45 million doses per year, and the company is awaiting approval for an additional facility to boost production to 200 million doses.
The investment in these manufacturing facilities is estimated at around $100 million, though Bharat Biotech has not confirmed this figure. The late-stage trial involved approximately 3,600 participants in India and demonstrated that the vaccine is safe and as effective as existing oral vaccines. WHO pre-qualification will require proof of efficacy, safety, and adherence to good manufacturing practices.
Bharat Biotech is a leading biotech firm recognized for its exceptional research and production capacities. Our goal is to provide inexpensive, secure, and top-notch vaccines and bio-therapeutics that aid individuals in overcoming illnesses. Our goal is to be at the forefront of biotechnology innovation in order to drive the battle against disease, specifically targeting emerging markets.