Dear Customers, Partners and Relevant Entities,
The film‑coating of Osimertinib Tablets manufactured by BigBear Pharma Co., Limited uses light‑brown coating powder. To further optimize supply‑chain management and achieve unified production administration, our company has adjusted suppliers for certain production materials, including suppliers of coating powder and tablet compression tooling.
Due to the change of coating‑powder supplier, light‑brown coating powder manufactured by different vendors may show discrepancies in colour shade, colour‑difference control and source of raw and auxiliary materials. As a result, minor differences in the film‑coating colour of finished tablets may be observed compared with previous batches. Meanwhile, following the replacement of the tablet‑compression‑tooling supplier, subtle variations may occur in tablet edge profile, score‑line appearance, surface smoothness and overall physical presentation. Accordingly, the product appearance may differ slightly from prior batches.
Affected Product Information
Product Name:Osimertinib(OYSIENDX)
Strength: 80 mg
Production Date: Products manufactured on or after 10 June 2026
For illustrative purposes, physical reference images of Osimertinib tablets from old and new production runs are attached:
(The above images are provided solely to demonstrate appearance differences.)
Confirmations
Evaluated and verified by our company’s Quality Department, the above‑mentioned alterations relate exclusively to product appearance. There have been no changes to the formula composition, manufacturing process, quality specifications, active‑ingredient content, dissolution behaviour, stability, safety or efficacy of the product. All affected products are tested in compliance with approved quality specifications and meet release criteria for production, distribution and clinical use.
This adjustment aims to strengthen supply‑chain integration, realise unified and standardised production and quality management, and further guarantee consistent product quality and sustainable supply capacity.
Contact Information
Should you have any questions or require further assistance, please contact our customer‑service team or relevant responsible personnel.
We sincerely apologise for any inconvenience caused and appreciate your understanding and support.
Solemnly declared.
