TAINAN, Taiwan, Jan. 18 /Xinhua-PRNewswire/ -- Oncological API specialist ScinoPharm announced the launch of Ondansetron Hydrochloride (HCl) API in the US after one of its clients recently received an Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA). This product launch came only a few months after the successful introduction of another cancer-treatment ingredient, Paclitaxel, from ScinoPharm.
"Ondansetron HCl is ScinoPharm's sixth API product marketed in the US," said Dr. Jo Shen, ScinoPharm President and CEO. "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.
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 range of services from custom synthesis for early phase pharmaceutical activities to brand companies and APIs for the generic industry.
Media Contact:
Jessie Wang
Jessie.wang@scinopharm.com.tw
Tel: +886-6-505-2888
