Ordain Healthcare Pvt Ltd, Chennai, will soon set up an office in New Jersey as parts of its plans to tap the US generics market. The company is expected to file its first Abbreviated New Drug Application (ANDA) by April 2007.
The office in the US will have a small volume-packing unit to cater to small volume products within USA besides doing all FDA related regulatory work. The research and development activities will be from Chennai. An eminent scientist with 20 years experience with US FDA work has joined Ordain as president for US operations.
The current factory in Chennai, set up with an investment of Rs 25 crore, will be further upgraded by adding more machinery. The amount to be invested for the purpose would be Rs 5 crore. Besides this, the company will be filing ANDA for manufacturing five products and the investment for that would be Rs 10 crore (Rs 2 crore for each filing).
ANDA need to be filed with USFDA to get permission to launch generic products. The application if approved during the expiry of patented drugs will get six months exclusivity to sell the products along with the original drug.
"The US generic drug market is expected to grow from a 30 billion USD market into a 163 billion USD market by 2010. So we do not want to miss the opportunity that is why we want to foray into the US market. Our focus is to grow into a 200 crore company by 2010 with Rs 100 crore from the domestic market and the remaining from the US market. We don't want to concentrate upon big molecules but on the niche market i.e. medicines that are used for rare indications, as the value will be more for that but the market will be less. Currently work to develop products equivalent to inventor products is going on in our factory, " said director of Ordain Health Care Pvt Ltd, J Jayaseelan.
Domestic business is being predominantly outsourced from Himachal to have huge excise savings, which will help funding EOU and for factory expansion. Ordain is in the process of tying up with companies from Australia and New Zealand to do contract manufacturing.
Speaking about the success of their domestic business that has marked a turnover of nearly Rs 50 crore from Southern and Eastern region and Gujarat and Lucknow, Jayaseelan said, "We are marketing our products through four exclusive marketing divisions. Acute Illness Task Force, meant for products related to Ortho, ENT's, Surgeons, etc, Chronic Illness Task Force concerned with products related to cardiologists, neurologists, gastroenterologists, diabetic task force related to dialectologists and physicians and paediatric task force products related Gynaecologists and Paediatrician."
The company, started with an investment of Rs Five lakh, is being managed by N Sudhakar (finance and corporate), J Jayaseelan, (marketing and manufacturing) and Pramodh (domestic sales, exports and administration).