| Type | Public Limited |
|---|---|
| Industry | Biotechnology |
| Founded | 2006 |
| Headquarters | Ahmedabad, India |
| Key people | Dr. Urmish Chudgar, Managing Director |
| Products | Neukine: GCSF/Filgrastim, Erykine: Erytheropioetin, Neupeg: PEG-GCSF, Intalfa: Interferon alfa2b |
| Employees | 410 (2008) |
| Website | http://www.intasbiopharma.co.in |
Intas Biopharmaceuticals Ltd. is an Indian biotechnology company headquartered in Ahmedabad, India. Located in the Moraiya,Ahmedabad,it is one of the leading biosimilar product manufacturer in Asia.
As an independent biopharmaceutical company of the Intas Group, the company has fully integrated biopharmaceutical operations with R&D facility and an EU-GMP certified bio-pharmaceutical manufacturing facility.[1]
Intas Biopharma is also actively pursuing the Contract Research and Manufacturing Services(CRAMS) line of business. To expand its CRAMS business, Intas Biopharmaceuticals Ltd., in June 2008, acquired a US biotechnology corporation, Biologics Process Development Incorporated (BPD), based in Poway, California. [2]
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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 biotechnology division was demerged as an independent company Intas Biopharmaceutcials Ltd. in Sep 2006. The ownership of the new company remained with the Chudgar family.
Kotak Private Equity Group invested USD 10 Million equity in the company in late 2007. Till that time company had invested $25 Million in its facility.[3]
The company faced EU-GMP (Good Manufacturing Practice) audit in Dec 2006, in order to seek approval of clinical trial of its biosimilar Filgrastim in Europe and was certified as EU-GMP compliant in April 2007, becoming the first company in India to receive such certification for biologics facility.
Apart from EU-GMP certification, the company also has approvals from MCC South Africa, Gulf Cooperation Council(GCC), Syria, Yemen, Belarus and several other national health authorities for its manufacturing facility and products.
Intas Biopharma has focused on biosimilars and has generic versions of 3 of the top 10 blockbuster drugs in its product basket. It launched its first product, Neukine injection (Filgrastim)/ GCSF, in July 2004.
Erythropoietin injection, under the brand name of Erykine, for anemia due to critical illness like chemotherapy, was introduced in Aug 2005 and Interferon α2b, under the brand name of Intalfa, was launched in April 2007.
Intas Biopharma also considers itself the first company in the world, after the innovator Amgen, to introduce a PEGylated version of GCSF (PEG-GCSF), under the brand name of Neupeg. Neupeg was launched in Aug 2007. The PEG (polyethylene glycol) form has a much longer half-life, reducing the necessity of daily injections.
Intas Biopharma plans to invest about US$ 30 million to set up a new drug manufacturing facility dedicated for large-scale manufacturing of Monoclonal antibodies based products. The commercial production at the proposed facility is likely to commence by year 2011. For set up of this plant Intas Biopharma signed a Memorandum of Understanding (MoU) with the Government of Gujarat for availing special incentives for the project.[4]
The company has entered into several supply and marketing agreements with several companies in regulated and semi-regulated markets of Europe, Asia-Pacific, Middle East, Russia & CIS, South and Central America and Africa.
Kwizda, Austria and Intas Biopharmaceuticals Ltd. jointly completed phase I clinical trial study of Neukine, biosimilar form of recombinant GCSF in April 2008, paving way towards start of Phase III Clinical trials in Europe.The study was a single-dose, randomised, double blind, two-way crossover trial and used an active control. With this study, Intas Biopharmaceuticals became first Indian company to enter the regulated biotherapeutic market. [5]
Intas Biopharmaceuticals Ltd 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.[6]
Apotex and Intas Biopharma 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.[7]
Indus Biotherapeutics Limited is a dedicated biopharmaceutical Contract Research Organization. This company solely concentrates on research and development of novel targets as well as bio-generics. Indus offers services in the areas of process and product development, analytical method development, bio-chemical immunological analysis, process validation, scale-up and technology transfer to manufacturing scale.
Biologics Process Development Inc., based in Poway, California, is a 100% subsidiary of Intas Biopharmaceuticals Limited, offering research services in the area of Molecular Biology. The biotechnology corporation offers range of R&D services including Express optimization, cell culture, bacterial fermentation, early-stage consulting services.
Celestial Biologicals Limited, focuses on marketing and distribution of plasma-derived products. The company is engaged in marketing of plasma proteins – Albumin, Globucel and Immunoglobulins (IVIG) in the Indian market. Celestial Biologicals is the only player in India, which sources plasma from various blood banks in within India. The company planning to create South Asia’s largest plasma fractionation facility.