85%Confidence
0Views
FDASource
2026-04-16Date
Summary
Appco Pharma's cGMP deviation for Prazosin capsules due to nitrosamine impurities signals potential supply chain disruptions for Biocon Pharma. This recurring issue across multiple strengths indicates systemic quality control problems at the manufacturing facility.
Actionable: Monitor Biocon Pharma's ability to secure alternative manufacturing capacity for Prazosin capsules.
AI Confidence: 85%
Data Points
firmAppco Pharma LLC
classificationClass II
statusOngoing
distributionU.S.A. Nationwide
productPrazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma
Get Signals Instantly
Premium subscribers receive every signal via Telegram the moment it fires — hours before it appears here.
Subscribe Now