- Recipharm AB has outfitted yet another one of its sites with serialization capabilities, further solidifying the company's position as a provider of the increasingly important regulatory service.
- Situated in Lisbon, Portugal, the site is Recipharm's sixth to receive such capabilities and adds four packaging lines to the company's larger arsenal. Recipharm plans to establish another seven lines at the facility in the second quarter of 2018, according to a Monday statement.
- Serialization involves placing a unique code on pharmaceuticals that allows them to be easily identified and tracked. The process has become a focal point for the industry since lawmakers passed the Drug Supply Chain Security Act (DSCSA) in 2013, requiring drugmakers to equip all of their products with those codes by Nov. 27, 2017.
Though the serialization deadline is only a month away, it seems likely the FDA will extend the date at which companies need to be compliant. Earlier this year, the agency issued draft guidance explaining it may push the deadline back one calendar year — mostly because many contract organizations didn't have adequate serialization capabilities whereas vendors that did were few and far between.
"FDA has received comments and feedback from manufacturers and other trading partners expressing concern with industry-wide readiness for implementation of the product identifier requirements for manufacturers," the agency wrote in its June proposal.
Recipharm, meanwhile, has been working to capitalize on the fledging serialization market. In 2015, the contract research and manufacturing organization announced it would invest SEK 150 million (about $18 million today) toward expanding its serialization services. Just a couple months later, Recipharm said it had completed a "complex serialization project" focused on Korea for Abbott Laboratories.
The company doubled down in the space in 2016, pledging €40 million to set up serialization capabilities across its many facilities. That investment helped bring its tally of serialization-ready sites to six. Notably, Recipharm had cash and cash equivalents of SEK 696 million ($78 million) and equity of SEK 4.8 billion ($539 million) as of Dec. 31.
“Recipharm recognised the complexity of implementing serialisation at a very early stage and so we’ve been preparing for the new regulations in the US and Europe for a long time now," the head of the company's global steering committee for serialization, Staffan Widengren, said in a statement. "The Lisbon facility brings us to over a third of the way through our implementation project and is an important milestone in our journey."
With the U.S. deadline for serialization looming and a similar provision set for Europe in 2019, Recipharm is likely to have a steady stream of clients and solid returns on its investment. To that point, a recent survey from professional services provider KPMG found more than 70% of responders, which covered the gambit from branded drugmakers to specialty biopharmas and smaller biotechs, said they intend on using serialization data to advance their businesses.
"Being ahead of the game in terms of serialisation will provide us with a competitive advantage and ensure that our organic growth is not limited by new industry regulations," Recipharm said in its 2016 annual report.