Sildenafil citrate, the active ingredient in Viagra, is manufactured under strict guidelines by FDA-approved facilities. These facilities must adhere to Current Good Manufacturing Practices (CGMP), ensuring consistent quality and purity. This includes rigorous testing at each stage of production, from raw material sourcing to finished product analysis. Independent labs frequently audit these facilities, verifying compliance with these standards. The entire process is meticulously documented, guaranteeing traceability.
Ingredient Sourcing and Quality Control
Pharmaceutical-grade sildenafil requires high-quality raw materials. Suppliers undergo thorough vetting, providing certificates of analysis demonstrating purity and potency. Throughout manufacturing, multiple quality checks identify and remove any substandard batches. Spectroscopic analysis confirms the chemical composition and purity of the final product, ensuring it meets the standards set by regulatory agencies.
Regulatory Approval and Oversight
Generic Viagra manufacturers must demonstrate bioequivalence to the brand-name drug. This means their product must provide the same active ingredient concentration and release profile as Viagra, ensuring comparable therapeutic effects. The FDA reviews extensive data, including bioavailability and pharmacokinetic studies, before granting approval. Post-market surveillance continues, monitoring product quality and safety.
