Lupin gets CDSCO nod for indigestion treatment tablets in India

The Dollar Business Bureau

Lupin Ltd. on Monday announced it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to introduce Acotiamide 100 mg indigestion tablets in India.

The introduction of the Acotiamide drug into the Indian pharmaceutical market is likely to benefit millions of patients suffering from Indigestion or Dyspepsia.

Acotiamide strengthens gastric emptying and gastric accommodation: the factors implicated for functional dyspepsia.

"Acotiamide is a first-in-class novel drug to be introduced into the Indian pharmaceutical market which could benefit millions of patients suffering from dyspepsia or indigestion, amongst the most common stomach complaints encountered in clinical practice," Lupin said in a statement.

“We have a rich legacy of having introduced novel treatments to address unmet medical needs in the country. I am sure that the approval of Acotiamide would go a long way in addressing an otherwise common but unmet medical need for a safe and effective drug for the management of dyspepsia” said Naresh Gupta, President, Lupin Ltd.

Acotiamide is approved by Pharmaceuticals and Medical Devices Agency (PMDA) Japan.

The current market for plain Gastrointestinal and its combination is estimated to grow at 14%, with its current value being around Rs.2,640 cr.

Lupin is a Mumbai-based pharmaceutical major, developing and producing a wide range of generic formulations, APIs and biotechnology products globally.