Luye Pharma: Efficient global serialization

Case study

Luye Pharma EU in Miesbach, Germany, is part of the global Luye Life Science Group, with headquarters in Yantai, China. The primary focus in Miesbach is development and production of Transdermal Therapeutic Systems (TTS).

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Results

4 months to first batch release

Successfully implemented the DSCSA-compliant serialization solution under extreme time pressure, enabling timely delivery to the US market.

100% standard solution deployment

Adopted Arvato CSDB as a hosted, customization-free system, avoiding development efforts and additional IT support investments.

Full regulatory compliance

Enabled Luye Pharma to deliver products in line with FDA DSCSA and EU 2016/161 directives, maintaining uninterrupted access to critical markets.

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