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The facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden, are the latest of Recipharm’s sites to be equipped to supply serialized products to the United States.
Contract development and manufacturing organization (CDMO), Recipharm, announced that it has equipped three more of its facilities with serialization capabilities in line with the United States regulatory requirements in time for the introduction of the Drug Supply Chain Security Act (DSCSA).
The facilities in Brescia, Italy and Karlskoga and Uppsala, Sweden, are the latest of Recipharm’s sites to be equipped to supply serialized products to the US. The CDMO now has nine facilities in total that are ready to offer serialization capabilities.
Following a EUR 40 million investment into its company-wide implementation program in 2016, Recipharm has already delivered more than 1.3 million serialized and aggregated packs to markets such as China, South Korea, Saudi Arabia, and Turkey where serialization regulations are currently in place.
“In addition to equipping nine of our sites ahead of the EU deadline and the new US 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,” Staffan Widengren, director of Corporate Projects at Recipharm and head of the global steering committee for Recipharm’s serialization project said in a press statement. “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 November 27, 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 investment we’ve made in terms of time, money, and resource means we’re well prepared ahead of time and a lot of our customers are already on-boarded. We can now refocus our attention on ensuring we realize the additional benefits of serialization implementation including improving line efficiencies and streamlining logistics operations,” Widengren said in the same release.
The next facilities to be equipped will be the company’s facility in Bengaluru, India, which will supply serialized products for the US.