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Digitalization does not mean a choice, but the inevitable course of enterprise development!
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Getting through the supply chain, connecting the terminal and reaching the consumer are the goal of industry digitization!
Real and reliable traceability data is the bottleneck of industrial digitization!
Establishing a unique code standard from the production source is the key to build the whole-industry chain digital system!
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Trace & Track Solution for Medicines Produced in China

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Track & Trace Compliance Solution Based on GS1 Standard for Drugs Exporting to China

Customers: Xi'an Janssen, Pfizer, Amgen, Bojian and Gilead

Drug Serialization Based on GS1 Standard

Successfully implemented 100+ imported medicine production lines, rich experience making us more trustworthy!

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Home > Typical Cases > TECHDOW: the first domestic project to serialize drugs exported to the EU

TECHDOW: the first domestic project to serialize drugs exported to the EU

Drug serialization EU

About Customers

TECHDOW is the largest production base and export enterprise of LMWH raw materials in China. With its strong scientific research strength, leading technology, reliable quality assurance system and excellent industrialization ability, the bulk drug products (enoxaparin sodium bulk drug, etc.) have won the excellent international authoritative qualification certification, and have successively passed the audit of more than 20 countries, including the FDA of the United States, the EMA of the European Union, the FDA of China, the TGA of Australia, ANVISA of Brazil, and INVIMA of Colombia.

1671940242684

Challenges faced by Customer

The laws and regulations of China, the United States and Europe shall be met at the same time.

Group platform management and control, and multi-factory production in different places are implemented, and product data informatization is centralized and complex.

There are many kinds of export products, which need to be equipped with hundreds of product specifications and dozens of packaging sizes.

The requirements for production flexibility are high, and flexible production modes such as "QR code+three dates", "only printing three dates without connection", "manual production when the automatic packaging line cannot be transferred", etc. are required.

Solutions

Based on the ESC production line coding system, GS1 QR code is printed on each saleable individual unit to realize coding, data acquisition, and establishment of packaging association.

With the PDM product data management system, it can effectively collect product production and inbound and outbound data, and upload them to the Tracelink cloud platform.

Project achievements

1 Compliance supervision: it complies with the requirements of traceability and supervision of China, the United States, Europe and other places, and becomes the first domestic serialized project of medicines exported to the EU.

2 Supply chain efficiency improvement: the management value of medicine serialization in the enterprise and supply chain is maximized on the premise of complying with the FDA/CFDA medicine serialization regulations.

Customer testimony

As the first code assignment project facing the EU market in China, in the face of many difficulties and complex challenges, Acctrue Technology has successfully delivered with tenacious spirit and exquisite professional technology, making our company the first domestic company to deliver serialized products to the EU market, and at the same time, we are also in the forefront of European peers.

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