ScinoPharm Launches More Cancer Treatment APIs in the US.TAINAN, Taiwan -- Oncological API specialist ScinoPharm announced the launch of Ondansetron Hydrochloride ondansetron hydrochloride Ondemet (UK), Zofran, Zofran ODT, Zofran Preservative Free Pharmacologic class: Serotonin type 3 (5-HT3) antagonist Therapeutic class: Antiemetic (HCl) API in the US after one of its clients recently received an Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA abbr. abbreviated new drug application ) approval from the US Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ). This product launch came only a few months after the successful introduction of another cancer-treatment ingredient, Paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); , from ScinoPharm. "Ondansetron HCl is ScinoPharm's sixth API product marketed in the US," said Dr. Jo Shen Shen, in the Bible, place, perhaps close to Bethel, near which Samuel set up the stone Ebenezer. , ScinoPharm President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "We are looking to a wider presence in the US with the two newest additions to our growing portfolio of oncological API products." Currently, out of the 22 DMFs the company has registered with the FDA, seven of them are oncological API products, including Docetaxel, the most recent submission. "We have many exciting new products in our pipeline," Dr. Shen added. Meanwhile, the company is also registering its products in other key markets such as Canada, Europe, South America, and Japan. Ondansetron HCl is a generic version of the most widely used antiemetic drug for patients undergoing chemotherapy or surgery. In the US, the patent of the brand drug expired on December 24, 2006. As for Paclitaxel, a widely used anti-cancer drug substance in the US market, ScinoPharm was awarded US patent 6,531,611 for its innovative synthetic scheme using 10-deacyl baccatin (10-DAB) as the starting material, a substance extracted from the needles of the yew tree. Direct extraction of Paclitaxel from the bark of the yew tree results in the killing of these valuable trees in the wild and this practice is now deemed illegal in many countries. Specialized in the development and manufacturing of highly potent and cytotoxic APIs, ScinoPharm's oncological products are currently available in around 40 countries where patents have already expired. Paclitaxel, Ondansetron HCl and other oncological APIs are manufactured at the company's FDA-approved, cGMP site in Taiwan, where multiple high-potency manufacturing suites are built together with an ultra-pure water system for the use of injections. 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 See Continuous net settlement. CNS See continuous net settlement (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 (Distribution Media Format) A floppy disk format from Microsoft that was used to distribute its software. DMF floppies compressed more data (1.7MB) onto the 3.5" diskette, and the files could not be copied with normal DOS and Windows commands. A DMF utility had to be used. 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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