Dr Reddy's Laboratories is making its debut in the biotechnology market with the company bagging approval from the Drug Controller General of India (DCGI) to market its maiden product Grastim (generic name filgrastim), the human granulocyte colony stimulating factor (hG-CSF). The company plans to launch the brand this month.
Grastim, a recombinant protein, is used in chemotherapy-induced neutropenia and bone marrow transplants. This product is also useful in the treatment of leukopenia associated with myelosuppressive therapies and in patients with AIDS-related cytomegalovirus retinites.
Dr Reddy's claims that it is the first company in India to develop this molecule all the way from the molecular biology stage to production and also obtain approval to launch in India.
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"The development of G-CSF for the first time in India and its launch this month marks a major milestone for Dr Reddy's in its foray into biotechnology," said Dr Jayaram Chigurupati, executive vice-president, (emerging businesses) in a release.
Grastim will cater to the needs and requirements of Indian consumers who are dependent on imported products, the release said adding that the biotech product pipeline has several recombinant products for treatment of cancer, diabetes and cardiovascular diseases in various phases of development..
Dr Reddy's formed the biotechnology division in 1998 to operationalise the recombinant proteins technology platform. The company has put together a team of skilled scientific and technical team to develop its biogenerics product portfolio.
Dr Reddy's has a complete biotech process and product development set up in the outskirts of Hyderabad, encompassing molecular biology, fermentation, protein purification, cell culture to final production, by using latest technology and multiple expression systems (E.coli, yeast and mammalian cells) to ensure high expression levels in yield leading to cost and market leadership.