Fumei is proud to announce the activation of its pharmaceutical-grade Carnauba Wax by Chinese Center for Drug Evaluation (CDE), NMPA, Registration No. F20190000460.
We offer two excipients: Cerapharm® Carnauba Wax 1012 and Cerapharm® Carnauba Wax 1012P which are complying with ChP/EP/USP/NF. Manufactured in our EXCiPACT-certified facility, both grades undergo a rigorous dual-refinement & filtration process. This manufacturing process ensures low levels of impurities, peroxides, and heavy metals.
In solid dosage forms, the 1012 series is frequently used for the final “polishing” step in sugar coated tablets or film coated tablets. It creates a dense, hydrophobic barrier on the tablet surface that not only resists moisture and masks bitter tastes but also yields a smooth, glossy finish that is resistant to abrasion.
Crucially, Carnauba wax serves as a key matrix-forming material in sustained-release formulations. Leveraging its high melting point and strong hydrophobic properties, formulators can precisely control the drug’s release rate within the body. For instance, in certain matrix tablets, the wax resists rapid penetration into the tablet core while allowing for gradual erosion by gastrointestinal fluids, thereby facilitating slow dissolution and steady drug release.
With the activation of Cerapharm® Carnauba Wax 1012 and Cerapharm® Carnauba Wax 1012P, domestic pharmaceutical manufacturers will benefit from a smoother associated review and approval process, ensuring a reliable supply of high-quality excipients for the development of advanced formulations.
