Recipharm, a contract development and manufacturing organization (CDMO), announced Monday that it has equipped three more of its facilities with serialization capabilities in line with the U.S. regulatory requirements under the November 27 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 U.S. and take the total number of facilities able to offer serialization capabilities to nine.
Following a €40 million ($47.6 million) investment into its company-wide implementation program in 2016, Recipharm said the company has delivered moe 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.
“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,” Staffan Widengren, director of corporate projects at Recipharm and head of the global steering committee for Recipharm’s serialization project, said. “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 U.S. deadline to avoid potential problems for our customers.”
Widengren said that Recipharm also introduced a serialization task force to ensure a consistent roll out across all of its facilities, adding, “We can now refocus our attention on ensuring we realize the additional benefits of serialization implementation including improving line efficiencies and streamlining logistics operations.”
The next facilities to be equipped will be the company’s facility in Bengaluru, India, which will supply serialized products for the U.S.
(Source: Recipharm AB)
