Dr Reddy's gets Chinese regulator nod for anti-blood clotting drug

business-standard | April 23, 2019

Sources said the company got approval earlier this month for generic Clopidogrel, which is used primarily to prevent blood clotting and acts against cardiovascular problems. Hyderabad-based Dr Reddy’s Laboratories (DRL), which is betting big on the Chinese drug market, recently got an approval for a $1.6-billion anti-blood clotting drug from the Chinese regulator after an 11-year wait. Sources said the company got approval earlier this month for generic Clopidogrel, which is used primarily to prevent blood clotting and acts against cardiovascular problems. The launch of the product is still some time away. This would be DRL’s biggest product in China in terms of market potential. The drug is now undergoing generic equivalent assessment (China requires drugmakers to conduct bioequivalence studies).

Spotlight

Globally, pharmaceutical regulators are becoming attuned to cold chain issues as biologics, vaccines, and other
temperature‐sensitive products are commercialized for a global clientele. Many regulators now recommend including
temperature monitoring technology in every cold chain shipment.


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Spotlight

Globally, pharmaceutical regulators are becoming attuned to cold chain issues as biologics, vaccines, and other
temperature‐sensitive products are commercialized for a global clientele. Many regulators now recommend including
temperature monitoring technology in every cold chain shipment.

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