Pharmaceutical partners seek safety certification

Rochem International and its partner Zhejiang Xinhua Pharmaceutical announced they have submitted a United States Veterinary Master File for Enrofloxacin USP to the U.S. Food and Drug Administration in February 2013. In addition, an Enrofloxacin EP certification submission has been made to European Directorate for the Quality of Medicines. Approval is expected in the first quarter of 2013.

Rochem International  and its partner Zhejiang Xinhua Pharmaceutical  announced they have submitted a United States Veterinary Master File for Enrofloxacin USP to the U.S. Food and Drug Administration in February 2013. In addition, an Enrofloxacin EP certification submission has been made to European Directorate for the Quality of Medicines . Approval is expected in the first quarter of 2013.

Zhejiang Xinhua Pharmaceutical, located in Linhai city, Zhejiang Province, China was founded in 1987 and is a manufacturer of pharmaceutical ingredients, intermediates and finished dosage preparations. They were inspected by the FDA and the World Health Organization in 2012. Rochem International became the U.S. Site Agent and Enrofloxacin Regulatory Agent for Zhejiang Xinhua Pharmaceutical in 2012 and has worked in partnership to further raise the level of compliance in their facilities as well as to file quality regulatory submissions. Rochem is also a sales and marketing partner for Zhejiang Xinhua Pharmaceutical in the U.S., European Union, and other regulated markets.

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