Amerigen’s Mecobalamin Receives CFDA Approval

The CFDA approval of Mecobalamin marks Amerigen’s entry into the Chinese generics market.

AsianScientist (Aug. 26, 2014) – Amerigen Pharmaceuticals Ltd’s Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., has received Chinese Food and Drug Administration (CFDA) approval and has subsequently launched its generic Mecobalamin 0.5 mg tablets into the China domestic 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.

Mr. 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 in China as we continue to bring high quality, locally manufactured generic products to the rapidly growing Chinese market.”

Mr. Wu Ziqiang, 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.”


Source: Amerigen Pharmaceuticals Ltd.
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