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BigBear Pharma: Product Update Announcement for Baricitinib (BARUDX)

Update: 13 Aug,2026 Source: Bigbear Views: 148

Dear Customers, Partners, and Relevant Parties:

Our company BigBear Pharma Baricitinib Tablets adopts pink coating powder for film coating. To further optimize supply chain management and achieve unified production management, we have adjusted some production material suppliers, including the coating powder supplier and the tablet compression tooling supplier.

Due to the change of coating powder supplier, there may be certain differences in color shade, color difference control, and raw material sources among different manufacturers' pink coating powders. Therefore, the coating color of the finished tablets may show slight differences compared with previous batches. Meanwhile, due to the change of compression tooling supplier, different toolings may have minor differences in edge morphology, scoring, surface smoothness, and overall appearance. Hence, the product appearance may vary to some extent from previous batches.

Product Information Involved

Product Name: Baricitinib

Strength: 4mg

Production Date: Products manufactured after June 24, 2026

For illustration, please find below the actual tablet images of Baricitinib produced before and after the change:

ScreenShot_2026-08-13_133355_303.png

(The above images are only for demonstrating the appearance differences)

Confirmation

As evaluated and confirmed by our quality department, the above changes only involve product appearance differences and do not alter the product formulation composition, manufacturing process, quality specifications, active ingredient content, dissolution behavior, stability, or product safety and efficacy. All related products have been tested in accordance with approved quality specifications and meet the release requirements. They can be normally produced, sold, and used.

The purpose of this adjustment is to strengthen supply chain integration and achieve unified and standardized product production and quality management, thereby further ensuring consistent product quality and continuous supply capability.

Contact Information

Should you have any questions or require further assistance, please contact our customer service or the responsible person in charge.

We apologize for any inconvenience caused and thank you for your understanding and support.

Hereby declared!

巴瑞克替尼4mg_包衣粉和模具更换申明_2026-06-24_00.png

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