Category: Manufacturing
FDA Deficiency Letters in Generic Drug Applications: Common Findings & Fixes
Discover the most common FDA deficiency letters in generic drug applications, including dissolution, impurities, and bioequivalence issues, and learn how to avoid costly delays.
Chinese Generic Production: Manufacturing Scale and Quality Concerns
An in-depth look at Chinese generic drug production, covering API dominance, quality control issues, regulatory reforms like the GCE program, and global supply chain strategies.
Pricing Pressure and Shortages: Why Manufacturers Are Struggling in 2026
Explore why manufacturers are facing intense financial strain due to pricing pressures, raw material shortages, and tariff volatility in 2026.
Quality Control Testing: Step-by-Step Process in Generic Manufacturing QA
Quality control testing in manufacturing ensures products meet exact standards through defined steps: setting measurable criteria, using proper tools, training staff, monitoring in real time, analyzing data, and fixing root causes. Skipping it risks recalls, reputation loss, and higher costs.