Dear Customers, Partners, and Relevant Parties:
Our company BigBear Pharma uses blue coating powder for film coating of Ivosidenib tablets. Due to the recent replacement of the coating powder supplier, there may be certain differences in color shade, color difference control, raw material sources, and production batches among blue coating powders produced by different manufacturers. Therefore, the coating color of the finished tablets may show color variation compared with previous batches.
Product Information Involved
Specification: 250mg
Product Name: Ivosidenib
Production Date: Products manufactured after May 1, 2026
For illustration, we have attached photographs of the actual tablets produced before and after the change:
(The above images are only for demonstrating the color difference of the coating powder.)
Confirmation
Our Quality Department has confirmed that this color difference is only an appearance variation. It does not involve any change in product formulation, manufacturing process, active ingredient content, quality specifications, or product stability, and does not affect product quality, safety, or efficacy. The relevant products have been tested and comply with our company's quality standards, and are hereby approved for normal release, sale, and use.
We commit to continuously strengthening the control over coating powder suppliers, raw material quality, production processes, and finished product quality to ensure consistent and reliable product quality.
Contact Information
Should you have any questions or require further assistance, please contact our customer service or responsible personnel.
We apologize for any inconvenience caused and thank you for your understanding and support.
This statement is hereby issued.
