Brand vs Compounded: What You Need to Know
Brand-name Egrifta WR is manufactured by Theratechnologies under FDA-audited cGMP conditions. Each vial is verified for potency, purity, and sterility. The cost is higher ($1,500 to $2,500/month without insurance) but the product reliability is guaranteed. Com
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- Brand-name Egrifta WR is manufactured by Theratechnologies under FDA-audited cGMP conditions. Each vial is verified for potency, purity, and sterility. The cost is higher ($1,500 to $2,500/month without insurance) but the product reliability is guaranteed.
- Compounded tesamorelin is produced by 503B outsourcing facilities using bulk tesamorelin active pharmaceutical ingredient (API). Compounded versions are legal because tesamorelin has FDA approval (the compound itself is not restricted, only the brand-name product has exclusivity for the specific formulation). Compounded tesamorelin typically costs $200 to $600/month.
- The trade-off is quality assurance. 503B facilities are FDA-registered and inspected, but the inspection frequency and depth is less rigorous than for branded pharmaceutical manufacturing. API sourcing varies. Some 503B facilities use U.S.-sourced API with certificates of analysis; others source from overseas with less transparent supply chains.
- For patients choosing compounded tesamorelin, look for: - 503B registration (not just 503A) - U.S.-sourced API with third-party testing certificates - Sterility testing on every batch (not just periodic) - A reconstitution calculator to verify accurate dosing: use our peptide reconstitution calculator
- For broader guidance on sourcing peptides safely, the is sermorelin safe article covers similar considerations for another GH-releasing peptide.