ScinoPharm Taiwan, the oncological API specialist, recently announced that the US Food and Drug Administration (FDA) had assigned a drug master file (DMF) number for its anticancer active ingredient Docetaxel. The company believes it is the first US DMF filer for the product.
[USPRwire, Thu Mar 22 2007] ScinoPharm Taiwan, the oncological API specialist, recently announced that the US Food and Drug Administration (FDA) had assigned a drug master file (DMF) number for its anticancer active ingredient Docetaxel. The company believes it is the first US DMF filer for the product.
Docetaxel is an antineoplastic agent used to treat a broad spectrum of cancers, including breast cancer, non-small cell lung cancer, stomach cancer and prostate cancer.
"Early US DMF filings help securing potential customers," noted Dr. Jo Shen, ScinoPharm President and CEO. "We are working hard to become the first DMF filer for the APIs that we are currently developing."
This Docetaxel US DMF submission adds to ScinoPharm's existing 22 US DMF registrations. In addition, the company is also registering this product in all other key markets. To date, ScinoPharm has DMF registrations for total of 22 products in more than 40 countries.
ScinoPharm has been awarded a patent in the US (US 6,531,611) for its novel semi-synthetic approach to produce a variety of taxane derivatives. The company will be producing Docetaxel at its Taiwan's GMP site where the plant is capable of producing more than 100 kg of this product per year.
The fast-growing oncology market is forecasted to become the second largest within the pharmaceutical industry by 2010. Docetaxel currently has global annual sales of more than US$2 billion.
Specialized in the development and manufacturing of highly potent and cytotoxic APIs, ScinoPharm's oncological products are presently available in over 40 countries where the corresponding substance patents have already expired. The product patent of Docetaxel is scheduled to expire in Canada at the end of 2007, and in the US and most European countries in 2010.
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About ScinoPharm Taiwan
ScinoPharm Taiwan Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With cGMP production facilities, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early phase pharmaceutical activities to brand companies as well as APIs for the generic industry.
ScinoPharm currently serves more than 140 customers worldwide, including some of the largest brand companies and almost all major generic companies.
ScinoPharm has also developed a broad portfolio of API products in the oncological, hormonal, antibiotics, and CNS arenas. To enable timely market launch, the company has been filing DMFs in as many countries as possible. To date, it has over 170 DMF registrations worldwide, 22 of which were filed in the US. For more information, please visit the company's web site at http://www.scinopharm.com.
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