21 August 2014 | Regulatory | By BioSpectrum Bureau
Amerigen Pharma recieved CFDA approval for generics of Mecobalamin
Singapore: US-based Amerigen Pharmaceuticals' Chinese subsidiary, Suzhou Amerigen Pharmaceuticals has received Chinese FDA (CFDA) approval for its generic Mecobalamin 0.5 mg tablets. The company has launched the drug in the Chinese domestic market.
Amerigen is manufacturing the product at its US FDA approved and China CFDA certified oral solid dose facility in Suzhou, China and Sinochem Jiangsu Pharmaceutical is distributing the product under the Suzhou Amerigen label with exclusive sales rights.
Mr John Lowry, president and CEO, Amerigen 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 Ziqiang Wu, General Manager of Sinochem Pharma, stated, "Sinochem is pleased to see that the Mecobalamin Tablet product produced by Suzhou Amerigen Pharmaceuticals 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."