Dear Customers, Partners and Relevant Parties,
Deucravacitinib (DUVACIDX) manufactured by BigBear Pharma uses pink coating powder for film coating. To further optimize supply chain management and achieve unified production management, our company has adjusted suppliers for certain production materials, including the supplier of coating powder and the supplier of tablet compression tooling.
Due to the change of coating powder supplier, pink coating powder manufactured by different suppliers may have certain differences in color shade, color difference control and source of raw and auxiliary materials. Therefore, the coating color of finished tablets may have slight differences compared with previous batches. Meanwhile, owing to the replacement of the compression tooling supplier, different tooling may have minor variations in edge profile, score line, surface smoothness and overall appearance. Hence, the product appearance may differ slightly from prior batches.
Affected Product Information
Product Name: Deucravacitinib (DUVACIDX)
Strength: 6 mg Production
Date: Products manufactured on or after 2026-05-01
For illustration purposes, physical photos of Deucravacitinib tablets from the old and new production runs are attached herewith:
(The above images are for demonstrating appearance differences only)
Confirmation Statement
After evaluation by our Quality Department, the above changes only involve product appearance. There is no alteration to the product formulation, manufacturing process, quality specifications, active pharmaceutical ingredient content, dissolution profile, stability, product safety or efficacy. All relevant products are tested in accordance with the approved quality specifications, and test results meet release requirements. The products can be manufactured, distributed and used normally.
This adjustment aims to strengthen supply chain integration, realize the unification and standardization of product production and quality management, and further guarantee product quality stability and sustainable supply capacity.
Contact Information
Should you have any questions or require further assistance, please contact our customer service or relevant personnel in charge.
We sincerely apologize for any inconvenience caused and appreciate your understanding and support.
Hereby notified!
