New Delhi, Sep 20 : Sun Pharmaceutical Industries,the country's most valued drug maker, aims to file 30applications in the US for manufacturing and marketing of itsgeneric products, company CMD said.
The company would file these applications along with itsUS-based subsidiary Caraco, which is facing trouble due tonon-compliance of current good manufacturing practice of theUS drug regulator.
"This year too, we intend to file 30 ANDAs in the USacross the two companies," Sun Pharma CMD Dilip Shanghvi saidin his speech to the shareholders of the company during theannual general meeting held last week.
We continue to spend for product development and file newproducts from these sites in India and the US, he said.
Between Sun and Caraco, 111 products are pending with the US FDA (Food and Drug Administration).
An abbreviated new drug application (ANDA) is anapplication for a generic drug approval in the US for anexisting licensed medication or approved drug.
The USD 30 billion-plus US generic market, the largestgeneric market in the world, is of great interest to allpharma companies across the world with global aspirations.
Last year, generics accounted for 71 per cent of the USpharma market by prescription.
India and the US, the two largest markets for Sun Pharma,together accounted for 80 per cent of the company's turnoverin the latest financial year.
Stating about the Rs 36,000-crore pharmaceutical market of India, Shanghvi said in here market competition has beenintense and will continue to remain so in foreseeable future.
Companies with global presence continue to either set upoperations or enter into contract manufacturing agreementswith companies in India with the purpose of creating a lowcost sourcing base for their global operations.
"Over and above this, competition from Chinese companiesis on the increase strong effort at enhancing their presencein the regulated markets globally," he said.
According to Shanghvi, the new patent regime, which was introduced in 2005, is likely to have an impact in the yearsto come.
"We expect the pipeline of new drugs available for launchto gradually shrink," he further said.
The recent acceptance of the revised Mashelkar Report,which recommends patenting of incremental changes may be an indicator of things to come. Of course, these are not thecountry's best interests in the long run.
Currently, in India the patenting of incremental changesare not allowed under the law.
"This will open up a floodgate of patent applications forrudimentary changes and may result in patent life beingextended far beyond what it is worth," Shanghvi added.
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