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New certification strengthens position in the pharmaceutical industry

GDP Certificate for Caldic Benelux
03 September 2019

Caldic obtains GDP Certificate for Active Pharmaceutical Ingredients

In May 2019, Caldic obtained the GDP (Good Distribution Practice) certificate for handling APIs at their Benelux site. With this new certification, the full-service distributor ensures product safety and quality during distribution across the entire supply chain. For Caldic, this new GDP certificate is yet another step in becoming a leading distributor for the European Pharmaceutical industry.

The GDP certificate was very much anticipated, as it refers to the regulatory guidelines governing the wholesale distribution, sourcing, storage and transportation of medicinal products. From the manufacturer to the end user, GDP ensures quality and integrity of active substances for the use of starting material in medicinal products for human use.

Raymond Tomatala, Product & Account Manager Pharma at Caldic Benelux, explains: “Since the beginning of Caldic’s activities in Pharma, it has always been our main goal to provide customers with the highest quality of products. In that sense, for us nothing has changed, but the certification certainly is a great token of reliability, quality and transparency. It proves that we are a trustworthy pharmaceutical solutions provider for the entire supply chain.”

Two years ago, Caldic Benelux already followed Caldic Denmark in obtaining the API registration and extended its existing portfolio of excipients, pharmaceutical intermediates and specialty solvents with API’s. For the past 10 years, the European API center at Caldic Denmark has been registered for handling APIs. The Danish department has always been working according to the GDP guidelines, so they expect to obtain their GDP certificate in 2020. 

Strong European Pharma Team

Last year, a European Business Development Team was established to enhance cooperation between all European entities. This European Pharma team, consisting of several specialists with extensive expertise and years of relevant experience, forms a profound base to further expand Caldic’s activities in the European Pharma industry. With the existing API business and the formation of a Business Development Team, Caldic now has the network, experience and knowledge to serve the Pharmaceutical Industry with a broad portfolio of products and services.

Expanding Pharma activities

Another development is the construction of a third clean room at the site in Belgium. Here, Caldic will be able to fill flammable and non-flammable pharmaceutical solvents into drums, IBC’s and even stainless steel IBC’s. Additionally, they now have a fully dedicated sourcing office in Shanghai to support the European business with API sourcing and validation of documentation. This office performs audits also with external companies to ensure compliance to EU legislation and established guidelines.