What is tesamorelin and who purchases it wholesale?

Tesamorelin (Egrifta) is an FDA-approved synthetic GHRH analog for HIV-associated lipodystrophy. It is purchased wholesale by compounding pharmacies supporting HIV specialty practices, endocrinology programs, and off-label metabolic health protocols.

What documentation is required for wholesale tesamorelin API?

Each tesamorelin lot requires: HPLC CoA ≥99% purity, mass spectrometry sequence confirmation, endotoxin result (<1 EU/mg), residual solvent analysis, SDS, and a chain-of-custody supplier letter. The FDA-approved reference product (Egrifta) means purity documentation is held to a high analytical standard.

What is the regulatory status of compounded tesamorelin?

Tesamorelin is FDA-approved as Egrifta, which means compounded versions face the same-as standard under 503A and 503B frameworks. Facilities should consult FDA guidance and legal counsel regarding compounding tesamorelin specifically.

What purity should wholesale tesamorelin API meet?

Tesamorelin API should meet HPLC purity ≥99%. Given its FDA-approved reference product status, purity and sequence verification documentation should be especially thorough for any regulatory review.

What vial sizes are available for tesamorelin?

Tesamorelin is typically available in 1mg and 2mg vial configurations, consistent with clinical dosing references. Contact our team for current availability and lot configurations.

Wholesale Tesamorelin API — Bulk Supply for Clinics & Pharmacies

Name: Wholesale Tesamorelin API
Brand: Wholesale Peptide Distributors
Availability: InStock

About Wholesale Tesamorelin

Wholesale Tesamorelin API for Licensed Facilities

Tesamorelin is a synthetic analog of growth hormone-releasing hormone (GHRH) that is FDA-approved under the brand name Egrifta for the reduction of excess abdominal fat (lipodystrophy) in HIV-positive adults. Beyond its FDA-approved indication, tesamorelin is studied and used in longevity medicine for its effects on body composition, visceral fat reduction, and GH axis support. Wholesale Peptide Distributors supplies tesamorelin bulk API manufactured in ISO 5, cGMP-aligned US facilities with raw API from FDA green list qualified manufacturers.

For 503A compounding pharmacies, bulk tesamorelin is used in the preparation of injectable formulations for physician-supervised programs addressing body composition goals, metabolic health, and GH axis optimization. Wholesale Peptide Distributors provides tesamorelin bulk API with HPLC purity ≥99%, mass spectrometry identity confirmation, endotoxin testing per LAL method, and complete chain-of-custody documentation consistent with USP Chapter <797> quality systems.

Longevity clinics and anti-aging practices that incorporate body composition optimization as part of their program menu increasingly source wholesale tesamorelin alongside other GHS peptides. Wholesale Peptide Distributors supports both standalone tesamorelin orders and combination orders including CJC-1295, Ipamorelin, and other growth hormone secretagogues.

Wholesale tesamorelin is available in bulk API quantities for 503A compounding programs. Pharmacy and clinic buyers should verify the current regulatory status and appropriateness of tesamorelin for their specific programs with their compliance team. Contact our wholesale team for current pricing, available lots, and documentation packages.

FDA-approved GHRH analog (Egrifta) — well-characterized regulatory history
Bulk API for 503A compounding under physician supervision
US-manufactured in ISO 5 cGMP-aligned cleanroom facilities
Raw API from FDA green list qualified manufacturers only
HPLC purity ≥99% per lot with identity confirmation
Endotoxin testing (LAL method, <10 EU/mg specification)
Chain-of-custody from green list raw material to delivery
Cold-chain 2-day nationwide shipping standard

What's Included with Every Wholesale Order

Certificate of Analysis (CoA)

Lot-specific CoA with HPLC purity (≥99%), mass spectrometry identity data, endotoxin results, and expiration date. Accessible in your account portal immediately upon lot release.

HPLC Purity Report

Full chromatogram confirming ≥99% tesamorelin purity. Required by most 503A pharmacy QA programs for bulk API acceptance per USP Chapter <797>.

Cold-Chain Shipping

Insulated packaging with temperature-controlled gel packs via certified 2-day cold-chain carriers. Temperature logs available for qualifying accounts.

Chain-of-Custody Documentation

Complete traceability from FDA green list raw material through ISO 5 US synthesis to your facility's receiving dock. Supports pharmacy QA file requirements.

Ready to Order Wholesale Tesamorelin?

Wholesale Tesamorelin — Bulk API & Finished Dose Supply