On November 21st 2023, Intas received a warning letter for a manufacturing facility in Ahmedabad, India and products from this facility were the subject of a related FDA import alert. Using the USP Medicine Supply Map, a database of 250 million points and 24+ sources of drug ingredients, drug products and manufacturer information, we identified that the Intas facility produces 94 drug products across 35 therapeutic classes, including cardiovascular agents and chemotherapy drugs. None of these 94 drug products have 100% market share. The FDA import alert excluded several products from detention without physical examination. The FDA may exclude certain products from detention without physical examination, particularly when these products are deemed vital for public health and their absence could trigger supply chain issues through a risk-based framework. Alternatively, the FDA may remove certain products from an import alert if the company presents credible evidence demonstrating that these specific products are not implicated in the concerns that led to the import alert. The USP Medicine Supply Map predicts that the impacted products will meet the demand and give enough time for other suppliers, governments, and health services to increase and manage their stocks to prevent shortages.
Based on the USP Medicine Supply Map, 26 of the 94 drug products made at the Ahmedabad site have a US market share greater than 15 percent. Three of those 26 drug products are already in shortage and excluded from the import alert, including Mycophenolic Acid Delayed-release Tablets which are indicated for the prophylaxis of organ rejection in adult and pediatric patients receiving a kidney transplant.
About USP Medicine Supply Map
The USP Medicine Supply Map calculates the vulnerability scores and market shares of drug products and APIs. Based on this data, USP can pinpoint drugs at heightened shortage risk in the mid-term (> 3 months), make recommendations to avoid drug shortages, and identify drugs that are not at significantly higher risk of drug shortage where pre-emptive action is not currently needed.
For additional information, please contact us at msm@usp.org to learn more.