CDMO's serialisation capabilities in place ahead of US deadline to avoid potential problems for our customers.
Recipharm has equipped three more of its facilities with serialisation capabilities in line with the US regulatory requirements in time for today’s 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 serialised products to the US and take the total number of facilities able to offer serialisation capabilities to nine.
Following a EUR 40 million investment into its company-wide implementation programme in 2016, Recipharm has already delivered over 1.3 million serialised and aggregated packs to markets such as China, South Korea, Saudi Arabia and Turkey where serialisation regulations are currently in place.
Staffan Widengren, Director of Corporate Projects at Recipharm and head of the global steering committee for Recipharm’s serialisation project said: “We’ve taken a very proactive approach to tackling serialisation 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 US enforcement date, we’ve also introduced a serialisation 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 penalised for failing to meet the mandate by the 27 November 2017. With this in mind, it was important to ensure we could offer serialisation 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 realise the additional benefits of serialisation 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 serialised products for the US.Read More