bioTE
Comprehensive Brand Analysis
Fast Facts
Company History & Milestones
• 2012: Founded by Dr. Gary S. Donovitz in Irving, Texas as BioTE Medical, building a network model to train providers on bioidentical hormone replacement therapy (BHRT) pellet procedures and to offer private‑label nutraceuticals. [Company overview/IR site; press/background.]
• 2012–2021: Expanded nationally via certified provider network; relied on FDA‑registered 503B outsourcing facilities to compound estradiol/testosterone pellets (e.g., AnazaoHealth; Right Value Drug Stores, LLC d/b/a Carie Boyd’s; later Asteria Health). FDA issued a 2017 warning letter to BioTE Medical regarding dietary supplement cGMP (21 CFR Part 111) deficiencies; FDA closed the matter in 2018 after corrective actions.
• 2022: Closed business combination with Haymaker Acquisition Corp. III and listed as Biote Corp (NASDAQ: BTMD), continuing to operate the BHRT training/distribution model and branded nutraceuticals.
• 2024: Launched BioteRx™ (medically directed wellness products) and pursued vertical integration in pellet supply through acquisition of Asteria Health (503B outsourcing facility) to improve supply chain control and margins.
Product & Manufacturing Profile
Core Products
BHRT pellet therapy (estradiol and testosterone pellets supplied to a provider network) and a portfolio of Biote‑branded nutraceuticals/cosmeceuticals (e.g., ADK 5/10, DIM SGS+, Iodine+, Omega 3 + CoQ10, Bacillus Coagulans, Methyl Factors+, Serene, Hair Rescue line, Arterosil® HP, UROX®+, Vascanox HP, ProLon programs).
Manufacturing Model
Hormone pellets are compounded by FDA‑registered 503B outsourcing facilities (historically including AnazaoHealth; Right Value Drug Stores/Carie Boyd’s; and Asteria Health, which Biote acquired), manufactured under drug CGMP (21 CFR Parts 210/211). Nutraceuticals are contract‑manufactured; at least some production has been performed under a Quality Agreement with Thorne Research (an established supplement manufacturer) consistent with 21 CFR Part 111.
Quality Certifications
Pellets manufactured under drug CGMP by registered 503B outsourcing facilities. Nutraceuticals produced under dietary supplement cGMP (21 CFR Part 111) via qualified contract manufacturers. As of August 2025, Biote is not listed in NSF’s Certified for Sport® directory (no NSF/USP product‑level certifications publicly indicated).
Third-Party Testing
503B outsourcing facilities conduct required release testing (e.g., potency, sterility, endotoxin) for compounded sterile pellets under CGMP. For nutraceuticals, testing is performed by contract manufacturers per cGMP and Quality Agreements; Biote does not routinely publish batch Certificates of Analysis on its consumer site.
Transparency
Ingredient Sourcing
Product pages disclose ingredient compositions but do not provide routine country‑of‑origin or supplier identity details for raw materials; pellet APIs are sourced through 503B partners per CGMP requirements.
Published Testing
No public batch‑specific COAs located on Biote’s consumer nutraceutical pages; pellets compounded by 503B facilities are subject to CGMP testing but results are not posted publicly.
Sustainability
No formal sustainability/ESG report found on investor or corporate pages; packaging/environmental initiatives are not prominently documented.
Trust Score
Trust Score: 3/10
Reasoning: Trust Score: 3/5
Reasoning: Biote is a publicly traded company with defined regulatory frameworks: nutraceuticals produced under dietary supplement cGMP via reputable contract manufacturers (including a formal Quality Agreement with Thorne), and hormone pellets compounded by FDA‑registered 503B outsourcing facilities operating under drug CGMP. The company resolved a 2017 FDA warning letter related to supplement cGMP deficiencies in 2018. However, compounded hormone pellet therapy carries ongoing regulatory and medical‑society scrutiny, including FDA communications about under‑reported adverse events and broader caution from professional groups regarding compounded BHRT. Public transparency on batch‑level testing/COAs for nutraceuticals is limited, and third‑party certifications (e.g., NSF/USP) are not publicly indicated. Balancing formal CGMP pathways, public company disclosures, and vertical integration of a 503B facility against these transparency and regulatory‑context concerns supports a middle‑tier trust rating.
Sources
- Biote – Executive Leadership (company address and current leadership)
- Biote – Nutraceuticals catalog (core products list)
- Biote Corp 2023 Form 10-K (business model; reliance on 503B outsourcing facilities)
- Biote 2023 Form 10-K – risk factors and 503B partners (AnazaoHealth, Right Value Drug Stores/Carie Boyd’s, Asteria Health)
- Quality Agreement between Thorne Research, Inc. and BioTE Medical, LLC (cGMP responsibilities under Part 111)
- FDA Warning Letter to BioTE Medical (2017) – dietary supplement cGMP violations
- FDA Closeout Letter to BioTE Medical (2018)
- FDA Statement (2019) on adverse event reporting for compounded drugs; pellet AEs context
- Endocrine Society – Position on compounded bioidentical hormone therapy (regulatory/clinical context)
- NSF Certified for Sport directory (Biote not listed as of Aug 24, 2025)
- Biote announces BioteRx product suite launch (Feb 7, 2024)
- Biote completes acquisition of Asteria Health (Jan 2, 2024) – 503B outsourcing facility
Featured Ingredients
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