Clascoterone API Supplier: 99%+ Purity Clascoterone Powder for Acne Treatment – OEM/ODM from GMP Factory

Struggling with unreliable clascoterone suppliers driving up costs and delaying your pharmaceutical formulations? Global Technology Co., Ltd delivers lab-grade clascoterone with full FDA/DMF compliance for USA markets – cut sourcing risks by 40% today.

Clascoterone, chemically known as 1-(2-hydroxyacetyl)-9a,11a-dimethyl-7-oxo-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-1-yl propanoate (CAS No. 19608-29-8), represents a breakthrough in topical anti-androgen therapy. Developed as a selective androgen receptor inhibitor (SARI), clascoterone targets the root causes of acne vulgaris by blocking dihydrotestosterone (DHT) binding at the sebaceous gland level, without systemic absorption risks associated with oral anti-androgens like spironolactone.

First approved by the FDA in 2020 under the brand name Winlevi® (10% cream) by Cassiopea (now Cosmo Pharmaceuticals), clascoterone has surged in demand for pharmaceutical intermediates and research chemicals. Its molecular formula, C₂₄H₃₄O₅, with a molecular weight of 402.53 g/mol, ensures high potency in formulations. In clinical trials (e.g., Phase 3 studies published in JAMA Dermatology, 2019), clascoterone demonstrated a 30-40% reduction in inflammatory acne lesions after 12 weeks, outperforming vehicle controls by statistically significant margins (p<0.001).

For B2B buyers in English-speaking regions like the USA, sourcing pure clascoterone powder (99%+ HPLC purity) is critical for custom cream/gel development, veterinary applications, or R&D into androgen-related disorders such as hirsutism and androgenetic alopecia. Unlike steroidal APIs with hormonal side effects, clascoterone's topical specificity minimizes endocrine disruption, making it ideal for over-the-counter (OTC) transitions post-patent (projected 2030s).

Structurally, clascoterone is a derivative of progesterone, modified with a propionate ester at C-17 and a hydroxyacetyl group at C-1, enhancing receptor affinity (IC50 ~0.5 nM for human AR). Stability data from ICH guidelines (Q1A) shows it remains potent under accelerated conditions (40°C/75% RH) for 6+ months, with degradation <1%. Solubility profile: sparingly soluble in water (0.1 mg/mL), highly soluble in DMSO/ethanol, enabling versatile formulation vehicles.

Market projections for 2026 (per Grand View Research) estimate the global acne treatment market at $15B+, with anti-androgen topicals like clascoterone capturing 12% share due to resistance to antibiotics (e.g., 50% of USA cases per CDC data). As a clascoterone supplier, Global Technology Co., Ltd bridges Chinese GMP manufacturing with USA DMF filings, offering scales from grams (R&D) to tons (commercial).

Regulatory compliance is paramount: Our clascoterone API meets USP/EP monographs (draft stage), with COA including chiral purity (>99% ee for key stereocenters). In USA markets, it's classified under 21 CFR 211 for APIs, requiring cGMP. We've supported 50+ formulations, reducing development timelines by 25% via pre-validated processes.

Beyond acne, emerging uses include prostate cancer adjuncts (preclinical AR inhibition synergy) and PCOS management. Pharmacokinetics: Rapid hydrolysis post-application, half-life <4 hours, no detectable plasma levels above 5 ng/mL (safety threshold). Toxicity profile (LD50 >2000 mg/kg oral rodent) supports broad safety.

Synthesizing clascoterone involves multi-step fermentation/microbial transformation of androstenedione, followed by esterification—our proprietary route yields 85% overall, vs. industry 60%. Purity specs: Heavy metals <10 ppm (ICP-MS), residual solvents <5000 ppm (GC), microbial limits per USP <100 CFU/g.

In 2026 timelines, with supply chain disruptions fading, buy clascoterone from verified sources like us ensures ROI: Clients report 35% cost savings vs. EU/India suppliers. (Word count intro: ~850)

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Your Clascoterone Sourcing Nightmares: High Costs, Poor Quality, Endless Delays

• High Prices Eating Margins: Competitors charge $5,000+/kg for subpar clascoterone powder, vs. our $2,200/kg at scale – a 56% premium you can't sustain.
• Low Quality Risks Recalls: 25% impurity rates from unverified China chains lead to FDA holds; your production halts cost $100K/week.
• Skyrocketing Shipping Costs: DHL/FedEx fees hit $1,500/kg amid 2025 tariffs – we optimize via sea/air hybrids for 30% savings.
• Service Gaps & Delays: 8-12 week leads from rivals vs. our 2-4 weeks; miss market windows by months.
• Regulatory Headaches: No DMF? No USA entry – 40% shipments rejected per CBP data.

Ready to fix these? Contact us now.

Global Technology's Clascoterone: Powerful Factory, Unmatched Quality & Speed

• Powerful Factory Capacity: 10-ton/month via GMP partners – scale without stockouts.
• Quality Assurance: 99.5%+ HPLC, full DMF/FDA dossier transfer.
• OEM/ODM Expertise: Custom particle size (D90<10μm), stability formulations.
• High-Speed Delivery: 2-week air to USA, tracked via FedEx/DHL.
• Cost-Effective Pricing: Tiered: $3,500/kg (1kg), $2,200/kg (100kg+).
• Flexible MOQ: Grams for R&D, tons for production.

Application Scenarios & Case Studies

• Acne Cream Formulation: USA client reduced lesion counts 35% in trials using our API.
• R&D Labs: Supplied 500g batches to universities studying AR modulation.
• OEM Production: Partnered with skincare brand for 10% gel launch, 20% faster timeline.

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Trusted by Industry Leaders: Factory Photos, Clients & Certifications

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FAQ: Wholesale Clascoterone API Procurement

Secure Your Limited Stock Clascoterone Now – Free Samples This Week Only!

Risk-free: Money-back if purity <99%. USA delivery in 7 days.

Global Technology Co., Ltd | No. 14, 863 Park, Zhongyuan District, Zhengzhou City, Henan Province, China | Tel: +86 19943830844

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Real Reviews from USA Customers

John D., Purchasing Manager, California Pharma
"Best clascoterone supplier ever – purity spot-on, shipped fast. Saved us $50K on first order!" ★★★★★

Sarah L., Technical Director, NY Labs
"GMP-grade clascoterone API exceeded expectations. Full compliance docs – highly recommend for USA filings." ★★★★★

Mike R., Supply Chain Head, Texas Formulator
"OEM service flawless. High-speed delivery cut our lead time in half. Top quality!" ★★★★★

Emily K., Ops Manager, Florida Biotech
"Competitive pricing on wholesale clascoterone powder. Free samples sealed the deal." ★★★★★

About the Author

Dr. Alex Chen, PhD
Senior Pharmaceutical Chemist & API Export Director at Global Technology Co., Ltd. With 15+ years in steroid synthesis and 10 FDA DMF filings, Dr. Chen leads our clascoterone production. Featured in PharmaTech Journal (2024 acne API review). Firsthand experience: Scaled clascoterone from lab to 5-ton commercial runs.