KeyPedia redefines Orange Book data for industry

Explore the sugammadex profile in KeyPedia.

This article annotates a case study with a KeyPedia customer that processes and produces drugs as part of a healthcare system. We have redacted the customer’s name to protect the featured team’s privacy.

KeyPedia has fundamentally redesigned the ontology for Orange Book activities, from interconnections with internal databases to better mapping the future of the generic drug supply chain. Much of this work depends on well-curated, high-fidelity data and an expert understanding of the Orange Book, the FDA database of approved drug products.

Resources such as Drugs.com have been useful to patients and clinicians alike. KeyPedia now helps bring that value to industry.

Pointed case study example

Take ANDA 214337. FDA’s approval letter identifies Aspiro Pharma Limited as the applicant for sugammadex injection. The Camber product label on DailyMed lists Camber Pharmaceuticals as the packager and connects NDCs 31722-254 and 31722-255 to that same application.

KeyPedia brings that relationship into one view: Aspiro as the application holder, Camber as the labeler, and the product presentations beneath the application.

This data also provides extensive, interoperable connections to:

• EQMS providers and systems of record
• Postmarket and audit data from a range of providers
• Other public sources of regulatory intelligence

All in one view through KeyPedia.

The most important aspects of this data are twofold.

Drug quality scores based on:

• Laboratory drug quality data and methods
• EU Qualified Person (QP) data
• KRA risk score data

These three points make KeyPedia’s data unique.

Supplier-related KRA scores in one view:

• Supplier-related KRA scores can now be viewed in one place.
• KRA scores provide unique insight for both generic drug selection and CMO and CDMO searches.

Learnings from the case study

• Alert monitoring for triple-indexed situations: Saving a company or drug is important, but retaining visibility into KRA scores for competitors and other related companies remains critical.

Sugammadex is one recent example of litigation, patent-cliff pressures and the need for medical systems to navigate a changing landscape.

Explore the sugammadex profile in KeyPedia.