"The current European approval provides access to a $200 million-market in Europe with a potential for a larger market with greater penetration of treatment in Europe," Piramal Group Chairman Ajay Piramal said.
The approval will serve as the basis to obtain commercial authorisation for the product in other geographic areas such West Asia, Asia Pacific region, South America and other countries including India, Piramal Healthcare said in a filing to BSE.
"The company plans to launch the BST-CarGel for commercial sale in the fourth quarter of the 2012 calendar year after completing user studies with key opinion leaders," it added.
Piramal Healthcare had acquired assets relating to BST-CarGel from Canada based BioSyntech Technologies Inc in 2010, the company said.
BST-CarGel is a European Union class III medical device, Piramal Healthcare said.
Scrips of Piramal Healthcare were today trading at Rs 453 per share in the afternoon trade on BSE, down 1.01% from its previous close.