The Sweden-based contractor said it would spend €40m ($44m) on serialization technology in February, citing requirements due to come into force in the US next year and Europe in 2019 as the driver for the investment.
Kjell Johansson, Recipharm’s president of manufacturing services in Europe, also cited the rules a a driver for the firm's decision to provide a free-of-charge serialization service.
“Serialisation will come into force in the US in 2017 and in Europe in beginning of 2019. It will be a huge challenge for our customers to adopt” he said, adding that “by being ready now we will be able to support our customers in this process.”
Recipharm is one of a number of CDMOs that has invested in serialization technology in recent years – Aesica and Almac being just two examples – and the market is becoming very competitive according to Johnson.
“We believe that our offer with no upfront payment, free of charge until the legal requirement comes into force and no volume commitment will be attractive to customers. This combined with a fixed fee for service will make it very simple for our customers.”
He added that: "Recipharm is prepared to take on the financial burden until legislation comes into force, to support customers to 'become serialized' as soon as possible."
No volume commitment
Pharmaceutical firms that use the service will have to agree to use the paid service when the regulations come into effect. However, they will not be required to make “volume commitments” Johnson said.
When Recipharm does begin charging, there will be a standard fee that will vary depending on the specific requirements of the project.
“We have already started to communicate with our customers what the fee will be for the above services. This fee relates to a ‘standard solution’ compliant with relevant legislation. In addition to this some customers want to have some extras, different printing, labels etc which will build the total fee.
“We will disclose the fee for our standard solution as soon as we have communicated this with our current customers” he said.