Dear Customers, Partners, and Relevant Units:
BigBear Pharma's Enasidenib is film-coated using yellow coating powder. To further optimize supply chain management and achieve unified production management, our company has adjusted suppliers for some production materials, including coating powder suppliers and tablet compression tooling suppliers.
Due to the replacement of the coating powder manufacturer, yellow coating powders produced by different manufacturers may have certain differences in color, color difference control, and raw and auxiliary material sources. Therefore, the coating color of finished tablets may be slightly different from previous batches. Meanwhile, due to the replacement of the tablet compression tooling manufacturer, different tooling may have subtle differences in edge shape, score lines, surface finish, and overall appearance. Therefore, the product appearance may change to some extent compared with previous batches.
Product Information Involved
Product Name: Enasidenib
Specification: 50mg
Manufacturing Date: Products manufactured on or after 2026-07-04
For ease of explanation, actual tablet images of Enasidenib produced before and after are attached below:
(The above images are only for the purpose of showing appearance differences.)
Confirmation Items
After evaluation and confirmation by our company's Quality Department, 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 are all inspected according to 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, realize unified and standardized product manufacturing 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 company's customer service or the relevant responsible person.
We deeply apologize for the inconvenience caused to you and thank you for your understanding and support.
Hereby declared!
