Suzhou Amerigen Pharmaceuticals has Received Chinese FDA Approval.
Amerigen Pharmaceuticals Ltd. announces that its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., has received Chinese FDA (CFDA) approval and has subsequently launched its generic Mecobalamin 0.5 mg Tablets into the Chinadomestic market. Under the terms of a marketing and distribution agreement with Sinochem Jiangsu Pharmaceutical Co., Ltd., Amerigen is manufacturing the product at its US FDA approved and China CFDA certified oral solid dose facility in Suzhou, China. Sinochem is distributing the product under the Suzhou Amerigen label with exclusive sales rights in the People’s Republic of China.
Approval and Launch.
John Lowry, Amerigen’s President & CEO, commented, “The approval and launch of Mecobalamin is Amerigen’s first generic product entry in China and we are very pleased to have Sinochem, a leading and highly reputable player in the Chinese pharmaceutical industry, participate in this important milestone as our sales and distribution partner. We expect additional near term product approvals inChina as we continue to bring high quality, locally manufactured generic products to the rapidly growing Chinese market.”
Mr. Ziqiang Wu, General Manager of Sinochem Pharma, stated, “Sinochem is pleased to see that the Mecobalamin Tablet product produced by Suzhou Amerigen Pharmaceuticals Co. Ltd. has been approved by CFDA, which embodies a solid step towards the business cooperation on generic drugs in the Chinese market. We also expect to deepen the cooperation with Amerigen and expand more high-quality drugs into this fast-growing drug market.”
Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business, with operations in the US and China. The group is controlled by Amerigen Pharmaceuticals Limited. The US regulatory and commercial activities within the group are conducted by Amerigen Pharmaceuticals Inc., based in Lyndhurst, NJ, USA. The group’s Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Limited, is located in Suzhou, Jiangsu Province. The group has an active portfolio of products under development, filed, or intended for filing, as ANDA’s with the US FDA and the Chinese CFDA. Amerigen’s focus is orally delivered products that are challenging to develop, require specialized technologies or high containment to manufacture, and present complex regulatory and intellectual property obstacles to bring to market. All Amerigen’s products are developed and manufactured by the company or its partners around the world to meet the highest quality standards, including the US FDA.