Intas Biopharmaceuticals Ltd., Biotechnology Division (R & D)

Intas Biopharmaceuticals was established in 2000 as an independent biotechnology division of Intas Pharmaceuticals Limited, an Indian multinational pharmaceutical company headquartered in Ahmedabad, Gujarat. It was incorporated by Urmish Chudgar, a hematologist. The division specialized in the development and manufacturing of biosimilar products based on recombinant DNA technology and monoclonal antibodies. In 2012–13, this subsidiary was merged back into the parent company, Intas Pharmaceuticals Limited, and it now functions as the company's Biologics Unit. The division underwent an EU GMP (Good Manufacturing Practice) audit in December 2006 to seek approval for a clinical trial of its biosimilar Filgrastim in Europe, and was certified as EU GMP-compliant in April 2007, making it the first company in India to receive such certification. In 2015, it launched its first biosimilar product, Filgrastim, in Europe, used to treat patients with advanced HIV infection and immune system disorders such as neutropenia. Beyond EU GMP certification, the division has received approvals from MCC South Africa, the Gulf Cooperation Council (GCC), Syria, Yemen, Belarus, and several other national health authorities for its manufacturing facility and products.