Tiel site registered as API producer – February, 2014
The Tiel site has been producing acetates used as Active Pharmaceutical Ingredients (API) by our pharmaceutical customers for a long time.
The FDA is coming in every two years to audit the plant for API’s shipped to the USA.
For API’s used in Europe the producer of the medical product had the responsibility to check if they were produced under Good Manufacturing Practices (GMP) as described in European guidelines. This has now changed. New European legislation states that all producers and traders in API’s need to be registered. After registration the local health authorities will come for an inspection and if approved will provide a GMP certificate to the API producer. This certificate will also be valid in other European countries. Producers of medical products will have to check for certification before using these chemicals.
Since the beginning of February 2014 the Tiel site is registered with the Dutch health authorities as can be seen in the included document. The inspection has been preliminary scheduled for May 2014. We will welcome the inspectors and work towards GMP certification for Calcium acetate and Sodium acetate tri-hydrate to start. We aim to have more products under this certification in the near future.