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Our commitment to support China's DMF system

Ensuring the well-being of your patients is your utmost priority. That's why you can place your trust in Roquette as a dependable partner, offering you reassurance and addressing your concerns regarding quality, stability, and formulation challenges.

With a rich history as a global provider of plant-based excipients and life-saving active ingredients for the pharmaceutical industry, Roquette delivers a comprehensive range of customer-centric solutions that are competitively positioned.

In China, the second largest pharmaceutical market worldwide, stringent regulations stipulate that all excipients and active pharmaceutical ingredients (APIs) utilized in medicines must undergo registration with the China Drug Master File (DMF). Rest assured, Roquette's DMF encompasses all the excipients we supply to the Chinese market. We have already issued more than 370 Letters of Authorization (LoAs) to customers who have submitted their joint-review requests to us (as of February 2019).