The FDA has launched a pilot program called the abbreviated new drug application (ANDA) aimed at enhancing the domestic manufacturing of generic drugs. This initiative encourages pharmaceutical companies to utilize local sources for active pharmaceutical ingredients (APIs), a move that is expected to bolster the resilience of the U.S. drug supply chain.
This program comes in response to ongoing concerns regarding the reliance on foreign suppliers for critical drug components, which has been highlighted during recent supply chain disruptions. By incentivizing domestic production, the FDA aims to mitigate risks associated with global sourcing and ensure a more stable supply of generic medications.
The implications of this program are significant for B2B professionals across the pharmaceutical sector. Regulatory, QA/QC, CMC, sourcing, and portfolio management teams will need to adapt their strategies to align with this shift towards domestic manufacturing, potentially leading to increased collaboration with local suppliers and a reevaluation of existing sourcing practices.
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