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Wockhardt
Ltd has become amongst first to receive approval from
the US FDA for marketing Zonisamide capsules in the
US market. Zonisamide is the generic version of Dainippon''s
Zonegran capsules.
As
per IMS data, the current market of Zonisamide in the
US is $ 74 million. The overall anti-epileptic market
is of $8 billion.
''Wockhardt
will be amongst the first company to launch generic
Zonisamide in the US," says Habil Khorakiwala,
chairman, Wockhard. "We have received this ANDA
approval in less than nine months from the filing, which
is a reflection of Wockhardt''s quality of research and
the capability of our regulatory affairs. We are end-to-end
integrated with this product right from manufacturing
of both API and capsule formulation to marketing the
product in the US," he added.
"Zonasimide is the first compound of its class
to be developed as an anti-epileptic agent. It has broad
spectrum of anti-epileptic activity, and is particularly
beneficial in refractory partial seizures and to a more
variable extent in generalised and compound / combination
seizures", said Khorakiwala,
Wockhardt
is a technology-oriented pharmaceutical and
biotechnology and one of its new drug discoveries has
entered phase II human clinical trials. The US and the
European Union contribute to half the company''s turnover.
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