Recipharm has equipped three more of its facilities with serialization capabilities in line with the U.S. regulatory requirements and today’s introduction of the Drug Supply Chain Security Act (DSCSA). 

The facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden, have been equipped to supply serialized products to the U.S., bringing the total number of facilities offering serialization capabilities to nine. The company invested €40 million in a company-wide implementation program in 2016.

Staffan Widengren, director of Corporate Projects at Recipharm and head of the global steering committee for Recipharm’s serialization project said, “We’ve taken a very proactive approach to tackling serialization as we understand the critical role that contract manufacturers must play in ensuring continuous supply of vital medicines in key markets. In addition to equipping nine of our sites ahead of the EU deadline and the new U.S. enforcement date, we’ve also introduced a serialization task force to ensure a consistent roll out of our standard solution across all of our facilities.” 

“While the FDA has announced a grace period ahead of the DSCSA deadline, companies can still be penalized for failing to meet the mandate by the 27th November 2017. With this in mind, it was important to ensure we could offer serialization capabilities by the original US deadline to avoid potential problems for our customers.”

The next facilities to be equipped will be the company’s facility in Bengaluru, India, which will supply serialized products for the U.S.