Lupin gets CDSCO nod for 2nd generation antihistanine medicine

The Central Drugs Standard Control Organisation (CDSCO) has given its approval to Mumbai-based multinational pharmaceutical company Lupin Limited for Bepotastine tablets — a new generation of antihistanine medicine that has been found more effective in controlling day time and night time triggers of allergic symptoms.


Lupin will commence promoting the drug in India soon, the pharma major said on Monday.

“We have a rich legacy of addressing medical needs in the country and introducing treatments to combat them. I am sure that the approval of Bepotatine would go a long way in addressing a common medical need for a safe and effective drug for the management of allergic symptoms,” said Naresh Gupta, President, Lupin Limited.

Bepotastine could benefit millions of Indian patients suffering from allergic symptoms. It is a rapid acting antihistanine that effectively controls day time and night time triggers of allergic symptoms.


Bepotastine has already been approved by Pharmaceuticals and Medical Devices Agency (PMDA) Japan and is actively marketed in Japan and other South East Asian countries.

The current market for plain antihistamine is estimated to be around Rs 860 crores and is growing at 14 per cent, according to IMS Health Market Reflection Report of March 2017.

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