Natco Pharma is upgrading its production infrastructure to strengthen its niche product base and will soon construct a peptide block to produce smaller peptides and APIs.
Rajeev Nannapaneni, chief operating officer, Natco Pharma told Pharmabiz that the peptide block would be operational by June 2006. The company is also constructing two new production blocks for anti-depressant and anti-ulcer drugs, besides facilities to produce injectables and soft gels for formulations. Natco has been spending at an average Rs 20 crore every year and the trend will continue in the coming years too, he said.
He said the company has been tapping niche markets and would continue to do that in future. The company has key regulatory approvals in place and marketing the drugs in regulated markets will not be tough. US FDA has recently inspected its finished dosage forms unit of the company and will start launching products from this unit by January 2006.
Natco has tied up with Temple University of Philadelphia to undertake specified biological studies for establishing the in vivo efficacy of some promising anti cancer compounds useful in the treatment of Chronic Myeloid Leukemia (CML). Results of this collaboration are likely to come out within next one year. In addition to in vitro studies, Natco is to carry out pharmacokinetics and toxicology studies for which it is talking to certain CROs. The company expects to complete all studies and plans to file an application for investigational new drug during the calendar year 2006.
"The company has filed two ANDAs in this financial year and plans to file two more by the end of 2005-06. It has filed seven DMFs in the current financial year and will be filing five more before March 2006," added Nannapaneni.
Natco has found export potential in overseas markets such as Canada, US, Western Europe. Half of its sales come from these markets, while the rest is from India and other Asian countries. The company is now eyeing markets such as Sri Lanka and Vietnam for marketing its finished dosages.
It has recently launched Vorizol, an antifungal product in tablet and injectable forms. The company is also planning to launch new products for oncology, besides 'Melphalan' for breast carcinoma and bone marrow depression. Natco has recently filed ANDA for ondansetron hydrochloride tablets in two strengths - 4 mg and 8 mg and is expecting to launch the product by December, 2006, as its patent expires by then.
Nannapaneni further added that the company has been strengthening its R & D team as per requirement. It has a research center housed by scientists in both process R & D and NCE development. It has a strong 35-scientist team and is to add 25 scientists by March 2006 who are going to be accommodated in the new blocks being created in the existing research center at Hyderabad.