DMF Registration in China for a Leading US Based API Manufacturer

US based, global Contract Manufacturer of Active Pharmaceutical Ingredients (APIs) and specialty chemicals. The Client’s customer, a finished drug manufacturer, planned to launch its pharmaceutical product in China. Therefore, the Client required to file a DMF in China in order to maintain the confidentiality of their manufacturing process and other API related information using a Drug Master File (DMF) strategy.

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Generic Drug Registration with NMPA in China

European based generic drug manufacturer who wants to expand to China seeks GRP as a partner to develop the appropriate regulatory strategy of the generic products in china, conduct the bioequivalence in china and register the products in china on its behalf and assist with planning its commercialization and regulatory strategy for China

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