Biological E Ltd announces that BioThrax® (Anthrax
Vaccine Adsorbed) receives market authorization in India
Hyderabad|India|June'2009: Biological E Ltd
announced that the Drugs Controller General of India (DCGI) has issued a
registration certificate for BioThrax® (Anthrax Vaccine Adsorbed), which
enables the marketing and sale of the vaccine in India to help prevent
anthrax infection. Emergent BioSolutions has signed a marketing agreement
with Biological E. Limited for the marketing of BioThrax in India.
BioThrax is the only vaccine for the prevention of anthrax infection
licensed by the U.S. Food and Drug Administration (FDA).
The BioThrax market authorization for India follows the publication in
July 2008 of the National Disaster Management Guidelines on Biological
Disaster by the National Disaster Management Authority (NDMA), which is
the government body that oversees disaster management. In that document,
the government of India provided guidance with respect to the management
of biological disasters and stated that there is a need to have a supply
of readily available anthrax vaccines to be administered rapidly in the
event of an outbreak. The report goes on to state that all first
responders will be vaccinated in an impending disaster situation whether
natural or man-made.
BioThrax:
"BioThrax is the only FDA-licensed vaccine for the prevention of
anthrax infection. It is licensed by the FDA as a pre-exposure prophylaxis
for use in adults who are at high risk of exposure to anthrax spores.
BioThrax is manufactured from a culture filtrate, made from a non-virulent
strain of Bacillus anthracis and contains no dead or live bacteria. Since
1998, the U.S. government has procured nearly 33.5 million doses of
BioThrax. During that time period, nearly 8.4 million doses have been
administered to more than 2.1 million military personnel. BioThrax cannot
cause anthrax infection.
Biological E. Ltd:
Established in 1953, Biological E. Ltd. (BE) has been a leading vaccine
and pharmaceutical company based out of Hyderabad, India. The company
produces a range of critical vaccines and has been an active partner with
the National Immunization Programs of various countries. The company
continues to invest in large-scale cGMP facilities in order to increase
its capacities and product range to offer vaccines/biologics on a global
basis including US FDA and EMEA markets. In addition to its pipeline of
vaccines and biologics, the company has entered into a number of strategic
collaborations with leading biotech companies and research institutes for
joint R&D projects. Biological E. is a privately held company and is run
by professionals with significant experience in the global
biopharmaceutical business
Reachout's News Bureau
June' 2009
