Caplin Point announced that its subsidiary Caplin Steriles has received approval from Brazil’s National Health Surveillance Agency ANVISA (Agência Nacional de Vigilância Sanitária) for its sterile injectable manufacturing site near Chennai, Tamilnadu.

The approval grants access to the company to register and market its products in Brazil, the largest pharmaceutical market in Latin America.

Mr C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited said, “Brazil is an important target for Caplin Steriles’ mid to long term expansion plans. As a first step, we will focus on extending our US approved products for Brazil.”

Caplin Steriles is a niche sterile product manufacturing company that is approved by US FDA and EU-GMP.

Caplin Steriles Limited has developed and filed 20 ANDAs in the USA on its own and with partners, with 16 approvals so far.