Industry Biotechnology Headquarters Ahmedabad Type of business Limited | Number of employees 300-350 (2013) Founded 2000 | |
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Products Neukine® (GCSF), Erykine® (EPO), Intalfa® (IFN), Pegasta® (Peg GCSF), Terifrac® (Teriparatide), Mabtas® (Rituximab), Folisurge® (FSH) Website | ||
The Biologics Business Unit (BU) of Intas Pharmaceuticals Limited was formerly an independent biotechnology company and was known as Intas Biopharmaceuticals Ltd. Intas Pharmaceuticals limited is an Indian company headquartered in Ahmedabad, India. The Biologics BU is located in Moraiya, Ahmedabad and is one of the leading biosimilar product manufacturers in Asia.
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The Biologics BU of Intas Pharmaceuticals has biopharmaceutical operations with R&D facility and an EU-GMP certified bio-pharmaceutical manufacturing facility.
History
Intas Biopharmaceuticals Limited was set up in year 2000, as an independent biotechnology division of Intas Pharmaceuticals Ltd., a mid-sized generic formulation manufacturer located in Ahmedabad, India. The BU was merged with the parent company Intas Pharmaceuticals Limited in the year 2013.
The company faced EU-GMP (Good Manufacturing Practice) audit in December 2006, to seek approval of clinical trial of its biosimilar Filgrastim in Europe and was certified as EU-GMP compliant in April 2007, becoming the first company in India to receive such certification for biologics facility.
Apart from EU-GMP certification, the company also has approvals from MCC South Africa, Gulf Cooperation Council (GCC), Syria, Yemen, Belarus and several other national health authorities for its manufacturing facility and products.
Products
Intas Biologics has an extensive product portfolio of biosimilars across microbial and mammalian cell culture. Its products include Neukine® (GCSF), Erykine® (EPO), Intalfa® (IFN), Pegasta® (Peg GCSF), Terifrac® (Teriparatide), Mabtas® (Rituximab), Folisurge® (FSH). It is India’s first biosimilars manufacturing unit to receive European Union - Good Manufacturing Practice (EU-GMP) certification for the Drug Substance (microbial) and Drug Product manufacturing facilities, attesting to highest quality of manufacturing and quality systems. In addition to the EU-GMP, Intas’ Biological BU facilities are approved by various other regulatory agencies such as ANVISA, GCC, MCC, Indonesia, etc.
Collaborations & Partnerships
Intas has several strategic marketing alliances and out-licensing collaborations with many International companies across both Regulated and Emerging pharmaceutical markets, such as Europe, China, S E Asia, Middle East, Russia & CIS, South & Central America and Africa.
Intas’ biosimilar are registered in more than 22 countries, and under registration in more than 25 countries, through strategic marketing alliances.
Three of Intas’ biosimilar assets are already partnered for the EU, US, Canada, China and other markets. The first product for the regulated markets will be GCSF and has received EU registration. Several other biosimilar programs are at advance stage of development, and available for partnering discussions.
Intas signed an agreement with Canadian drug major Apotex Inc, in May 2008, to co-develop and market the low-cost version of a biotech cancer medicine filgrastim (G-CSF) in North America and Europe. Intas developed and manufactured Filgrastim (GCSF) became the first biosimilar manufactured by an Indian company to be registered in EU.
Apotex and Intas in Jan 2009 extended their agreement to develop a biosimilar version of pegfilgrastim. This collaboration gives Apotex the rights to market the product manufactured by Intas Biopharmaceuticals in North America, Europe and selected other countries.
European Union Approval
Accord Healthcare, the international arm of Intas Pharmaceuticals Ltd, has received marketing authorization for its filgrastim (Brand name Accofil) valid throughout the European Union. The product is manufactured by Intas in its EMA certified plant in India. Accofil has already won two tenders in Netherlands and the UK. The product is one of the many biosimilars that Intas will be launching in the European Union, USA and other regulated markets.