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Intas Biopharmaceuticals : ウィキペディア英語版
Intas Biopharmaceuticals

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.
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.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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