The Mumbai-based JB Chemicals & Pharmaceuticals Ltd is planning to set up a full fledged drug research and development facility near Pune with an investment of Rs 40 crore. The unit, which is funded entirely through internal accruals, will be completed in a phased manner within three years. With the commissioning of this second such research facility of the company, JBCPL would be increasing its research and development spend to 2.5 - 3 per cent of its sales.
While speaking to Pharmabiz, a senior company official said that with the setting up of the R&D unit, the company expects to file 8-10 ANDAs (Abbreviated New Drug Applications), up from 3-4 with the USFDA (United States Food and Drug Administration) every year. The facility will house about 80 scientists, of which 40 will hold senior positions. JB Chemicals has an existing R&D unit at Thane and as of now there are no plans to integrate both the units, he added. However, the senior management who are directly responsible for the operations will be common for these centers.
The areas of work that the unit will carry out include pharmaceutical formulations, NDDS (New Drug delivery Systems), synthetic chemistry, analytical chemistry, contract research, international regulatory office and NDDR (New Drug Discovery Research).
The company has identified Dr Rajen Shah as the whole-time director of R&D. The company plans to enter diabetes, respiratory and oncology segments and is to launch three to four products from these segments soon. The company expects its first ANDA approval by December 2003. JB Chemicals had filed an ANDA for ciprofloxacin tablets in the US for three concentrations, 250, 500 and 750 mg through a joint venture with US-based Spectrum Pharmaceutical Inc. The current US market for this product is estimated at $1.5 billion.