Emergent BioSolutions received a registration certificate from the Drugs Controller General of India allowing the company to market and sell BioThrax, which has FDA approval as a vaccine for anthrax.
The company signed an agreement with Biological E., an Indian private sector biological products company, to market BioThrax in India.
The vaccine authorization follows the 2008 publication of guidelines by the Indian National Disaster Management Authority stating the country needed a readily-available supply of anthrax vaccines in the event of an outbreak.
"The government of India has been explicit in expressing its commitment to protect its population from the continuing threat of bioterrorism," says Fuad El-Hibri, chairman and CEO of Emergent.
BioThrax is already widely accepted by the U.S. military with approximately 8.4 million doses administered, says Emergent. Since 1998, the U.S. government procured nearly 33.5 million doses of BioThrax.
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