Great Excipact-ations: more excipient firms certified as predicted

BIOGRUND GmbH of Hunstetten, Germany

Four more drug excipient suppliers have been certified under the newly independent Excipact quality scheme.

When Excipact left industry group IPEC Federation to set up as an independent organisation in January it predicted that the move would allow it to expand globally and attract more suppliers, which is forecast that has so far proved to be accurate.

On Tuesday the organisation announced that Amsterdam, Netherlands-based Sonneborn Refined Products had been certified following a visit by auditor SGS. A day later it revealed that Saudi Kayan Petrochemical Company, a unit of Sabic, had achieved the same status.

Saudi Kayan Petrochemical Company, which is based in Jubail Industrial City in Saudi Arabia, was the first non-European organisation to gain certification.

However, this status lasted until earlier today when the firm was joined by A&C American Chemicals Company of Saint-Laurent, Canada on the list of non-European companies that have made the grade.

Also today, Germany-based manufacturer Biogrund GmbH also gained certification.

All of which means that to date seven pharmaceutical excipient producers have been certified under excipact, including previously announced firms BASF, Seppic and Merck KGaA.

Audit burden

The spate of new certifications is in keeping with comments by IPEC Europe vice chairman Frithjof Holtz who predicted, during an address at CPhI in October, that more companies would seek certification in the face on increasing customer demand for audits.  

Holtz, who is also head of advocacy at Merck Millipore, said: “There are increasing expectations from regulators on ensuring the safety of supply chain means more physical audits of manufacturer, suppliers and distributors.

One way of handling the challenges of quality standards for excipients and of physical audits might be excipact.”

Evidently, at least seven manufacturers agree.

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