Industrial Achievements

2010:

March

Anhui Wanbei Pharmaceutical Co. Ltd. Passes Their First U.S. FDA Inspection

Rochem International Inc. represented manufacturer, Anhui Wanbei Pharmaceutical Co. Ltd., has passed their first ever U.S. FDA inspection in March, 2010. They have the distinction of being the first FDA approved facility in Anhui Province, China. Rochem’s partnership with Wanbei began in October 2008 and since then Rochem has worked closely with Wanbei, though extensive on-site training and audit support, to raise their GMP compliance level ensuring their operations are fully GMP/FDA compliant. Wanbei manufactures various products using classical fermentation and semi-synthetic technologies. Rochem is Wanbei’s site agent and is the exclusive supplier of various grades of Lincomycin HCl, Clindamycin Phosphate and Clindamycin HCl manufactured by Wanbei to global regulated markets.

2009:

August

Rochem International has been authorized by Changzhou Sunlight Pharmaceutical as their Exclusive Agent for Benzocaine for the North American market. Rochem has distributed Sunlight’s Benzocaine for over a decade and as the largest importer of Sunlight’s Benzocaine, Rochem is able to provide the high level of customer service that users demand. Sunlight operates a cGMP compliant factory, is filing a DMF for Benzocaine, and would welcome the chance for customers to arrange for audits through Rochem International.

July

Rochem International has been authorized to be the exclusive agent in the North American Market by Shandong Futaste Pharmaceutical Co. Ltd. (Previously known as Shandong Futian Pharmaceutical Co. Ltd.) for Xylitol. Shandong Futaste is the largest xylitol manufacturer in Asia, the second largest in the world with a capacity of 40,000 MTS annually. Rochem is the largest importer and distributer of xylitol in North America. Rochem pioneered xylitol of Chinese origin to the U.S. market in the early 90's.

March 8

Mr. Stephen Rivoir, Rochem’s Director of Food & Nutritional Ingredients in North America was invited as a guest speaker by the largest Xylitol manufacturer in China, our partner, Shandong Futaste Pharma Co. Ltd. and the largest manufacturer of IMO in China, Shandong Baolingbao Biotech Co. Mr. Rivoir discussed the growing trends in pre-biotics and functional fibers and the opportunities that exist in the international markets for producers in China. This was held during the FIC (Food Ingredients China) convention held in Shanghai.

2007:

May

Rochem filed a Canadian DMF for Clotrimazole, manufactured by Jiangsu Yunyang Pharmaceutical Co. Ltd.

April
Rochem’s pharmaceutical team from the US and Europe spent two weeks in China visiting with and auditing various pharmaceutical, nutritional and sweetener manufacturers. This is the seventh time in fourteen months that Rochem US/Europe has visited and audited facilities in China and is an example of what separates Rochem from other distributors.

April
Rochem filed the following two DMF’s with the U.S. FDA:
– Clotrimazole, manufactured by Jiangsu Yunyang Pharmaceutical Co. Ltd.
– 10-DAB, manufactured by Beijing Yi-he Biotech Co. Ltd.

March
Rochem commercialized the supply of Xylitol, 170 micron

February
Rochem filed the following five DMF’s with the U.S. FDA:
– Flutamide, manufactured by Jiangsu Tasly Diyi Pharmaceutical Co. Ltd
– Progesterone, manufactured by Jiangsu Changzhou Jiaerke Pharmaceutical Group Corp. Ltd.
– Mecobalamin, manufactured by Hebei Huarong Pharmaceutical Co. Ltd
– Azithromycin, manufactured by Zhejiang Guobang
– Pharmaceutical Co. Ltd
– Methrotrexate, manufactured by Huzhou Zhanwang Pharmaceutical Co. Ltd.