Dear Customers, Partners and Relevant Parties:
Our company, Daewoong Pharmaceutical Co., Ltd., uses light brown coating powder for film coating of Apalutamide Tablets. 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, the light brown coating powder from different manufacturers may have certain differences in color, color difference control and source of raw and auxiliary materials, so the coating color of finished tablets may vary slightly compared with previous batches. At the same time, due to the change of tablet compression tooling supplier, different tooling may have slight differences in edge shape, scoring, surface gloss and overall appearance, so the product appearance may vary compared with previous batches.
Product Information Involved
Product Name: Apalutamide
Strength: 60 mg
Production Date: Products manufactured after June 5, 2026
For illustration, we attach the actual tablet images of Apalutamide produced before and after the change:
(The above images are for visual comparison of appearance differences only)
Confirmation
Our quality department has assessed and confirmed that 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 the approved quality specifications and the results meet release requirements, so they can be normally manufactured, marketed and used.
The purpose of this adjustment is to strengthen supply chain integration, achieve uniformity and standardization in production and quality management, and further ensure stable product quality and continuity of supply.
Contact Information
If you have any questions or need further assistance, please contact our customer service or the responsible person.
We apologize for any inconvenience caused and thank you for your understanding and support.
Hereby declared!
