Pursuing the growth momentum of pharma companies in the country, the Aurangabad based FDC Ltd is planning to commercialise a cytokines factor along with a plan to foray into central nervous system (CNS) and anti-diabetes segments within one and a half year.
The Human Granulocyte Colony Stimulating Factor (GCSF), designed as a low volume-high value product, is expected to hit market within 18 months. The company has completed technology transfer from an overseas company and is waiting for regulatory clearance for the recombinant human cytokine, according to company sources.
The company is actively involved in the process of introducing an additional chromatography step to obtain high quality consistent pure product. According to a report, FDC has entered into technology agreement with an Israel based company for development of the product.
After facilitating the new step, the consistency batches will be submitted to the review committee on genetic manipulation for which the company has already obtained permission from the Department of Biotechnology (DBT), according to reports. Though refused to comment more on the rDNA product, the company officials informed that it is a billion dollar product already established in the global market.
The company is also lining up a total six to eight active pharmaceutical ingredients (APIs) as the part of its plan to enter into CNS and anti diabetes segment. The company has to set up a new facility either for intermediates or for formulations, with the expansion in product range.
"We have core competence in ophthalmic and anti fungal APIs and formulations and the entry into CNS and anti-diabetes segments will happen within next 18 months," said a company source.
The Rs 470 crore FDC, which has filed 11 DMFs, five Certificate Of Suitability (COS) approval from the European Directorate for Quality Medicines (EDQM) and five ANDAs, expects to own six new DMFs, two CoS and two fresh ANDAs within the current financial year. The company is also lining up around seven new chemical entities (NCEs) in its R&D.