90%Confidence
0Views
FDASource
2026-04-15Date
Summary
Another Appco Pharma cGMP deviation for the 2mg Prazosin strength confirms pattern of manufacturing quality issues. This repeated problem across dosage forms increases regulatory risk for both Appco and Biocon Pharma.
Actionable: Evaluate Biocon Pharma's dependency on Appco manufacturing and potential need for alternative suppliers.
AI Confidence: 90%
Data Points
firmAppco Pharma LLC
classificationClass II
statusOngoing
distributionU.S.A. Nationwide
productPrazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma
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