Dear Customers, Partners, and Relevant Parties,
Our company’s Enasidenib tablets are film-coated using yellow coating powder. To further optimize supply chain management and achieve unified production management, our company has adjusted the suppliers of certain production materials, including the supplier of coating powder and the supplier of tableting dies.
Due to the change in coating powder manufacturer, yellow coating powders produced by different manufacturers may differ to some extent in color, color-difference control, and sources of raw and auxiliary materials. Therefore, the coating color of finished tablets may differ slightly from that of previous batches. At the same time, due to the change in tableting die manufacturer, different dies may have slight differences in edge shape, score lines, surface finish, and overall appearance. Therefore, the product appearance may vary to some extent compared with previous batches.
Product Information Involved
Product Name: Enasidenib (Enasidx)
Specification: 100 mg
Production Date: Products manufactured after July 4, 2026
For ease of explanation, actual tablet images of Enasidenib produced before and after the change are attached below:
(The above images are only used to illustrate appearance differences.)
Confirmation
Our company’s Quality Department has evaluated and confirmed that the above changes only involve product appearance differences and do not change the product formulation composition, manufacturing process, quality standards, active ingredient content, dissolution behavior, stability, or product safety and efficacy. The relevant products have been tested in accordance with the approved quality standards, and the results meet release requirements. They can be manufactured, sold, and used normally.
The purpose of this adjustment is to strengthen supply chain integration, achieve unified and standardized production and quality management, and further ensure product quality stability and continuous supply capability.
Contact Information
If you have any questions or need further assistance, please contact our customer service or the relevant responsible person.
We sincerely apologize for any inconvenience caused and appreciate your understanding and support.
This is hereby announced.
