The Mumbai-based Wockhardt Ltd is awaiting DCGI approval for the launch of its biotech product interferon alpha 2b. After finishing phase III trials on the product, the company has submitted its final dossiers with the DCGI anticipating marketing approval, said reliable sources.
It has already received necessary clearances from the Department of Biotechnology (DBT), sources revealed.
Interferon alpha 2b (IA2b) is a recombinant version of the naturally occurring leukocyte - white cell - alpha interferon, which has demonstrated anti-viral capabilities and the ability to regulate or adjust immune responses. IA2b treatment is designed to stimulate an antibody response against cancer. The drug is considered to be highly effective against some cancers like Melanoma, a fatal skin cancer.
Wockhardt is going to be the second indigenous manufacturer after Shantha Biotech to enter the interferon 2b market. The total interferon market in the country is estimated to be worth Rs 34 crore, with Shantha Biotech garnering a share of 20 per cent in the domestic market. The rest of the companies marketing the drug are MNCs, who import the product.
Wockhardt launched its initial biotech product, recombinant human insulin in August 2003. The company's another product quadraple vaccine is in the advanced stages of phase III clinical trials, revealed sources. The products are manufactured at its biotech facility in Aurangabad.