US Generic Antiseizure Medication Supply Chain: Observations from Analysis of US Government Databases

Area of Science:

• Pharmaceutical supply chain analysis
• Generic drug manufacturing oversight
• Medication shortage prevention strategies

Background:

• Globalized and complex medication supply chains have led to manufacturing bottlenecks and drug shortages.
• Understanding the complexities of antiseizure medication (ASM) supply chains is crucial for preventing shortages.

Purpose of the Study:

• To analyze the generic antiseizure medication (ASM) supply chain.
• Focus on production, labeling, and repackaging processes.
• Identify manufacturing locations and supply chain vulnerabilities.

Main Methods:

• Utilized data from the U.S. Food and Drug Administration (FDA) and National Library of Medicine's DailyMed.
• Evaluated supply chain details for ASM formulations, manufacturing sites, and labeling.
• Analyzed Abbreviated New Drug Application (ANDA) data for 2663 NDC-9 codes.

Main Results:

• India is the primary producer of enteral ASM Finished Dosage Forms (FDFs), with 49 manufacturing sites.
• Limited global facilities exist for parenteral ASM FDF production.
• Significant data gaps were found, with 22.7% of ANDAs lacking manufacturing facility identifiers; 48% of NDC-9s involved repackaged FDFs.

Conclusions:

• Over-reliance on India for generic ASM FDF manufacturing poses supply chain risks.
• The scarcity of parenteral ASM FDF manufacturing sites highlights a critical vulnerability.
• Increased transparency in the ASM supply chain is urgently needed due to missing data.