Isotretinoin - Potent Oral Retinoid for Severe Acne & Dermatological Disorders

As a professional supplier of pharmaceutical-grade dermatological active ingredients, we provide high-purity Isotretinoin that strictly complies with global pharmacopoeia standards (USP, EP, BP, CP). A synthetic retinoid (derivative of vitamin A), it is recognized as a "gold standard" for treating severe, refractory acne and certain keratinization disorders, offering long-term remission for patients with unmet therapeutic needs.

Product Basic Information

Product Core Functions & Applications

Isotretinoin exerts multi-faceted effects on the skin by regulating keratinization, reducing sebum production, and suppressing inflammation-addressing the root causes of severe acne. It is exclusively used in human pharmaceutical formulations (no veterinary application) due to its specific dermatological efficacy and safety profile:

1. Severe Acne Vulgaris (Primary Indication)

Treats severe nodular/cystic acne that is unresponsive to conventional therapies (e.g., oral antibiotics, topical medications). It significantly reduces:

Sebum gland activity (by up to 90%), minimizing oily skin and pore clogging.

Abnormal keratinization of hair follicles, preventing the formation of microcomedones (acne precursors).

Inflammatory lesions (nodules, cysts) by inhibiting pro-inflammatory cytokines and reducing bacterial colonization (e.g., Cutibacterium acnes).

Key Advantage: Induces long-term remission (60-80% of patients remain acne-free for ≥1 year post-treatment), reducing the need for lifelong maintenance therapy.

2. Other Dermatological Disorders

Keratinization Disorders: Used off-label for conditions like pityriasis rubra pilaris (scaly, red skin patches) and Darier's disease (keratinization defect causing warty papules), improving skin texture and reducing scaling.

Severe Rosacea: Reserved for treatment-resistant papulopustular rosacea (when other therapies fail), targeting inflammatory lesions and abnormal vascular responses.

Dosage Form: Primarily formulated as oral capsules (standard dosage: 0.5-1 mg/kg/day for 12-20 weeks) - topical formulations are rare due to potential skin irritation and limited efficacy for severe cases.

Quality & Safety Assurance

Isotretinoin is a prescription-only medication with strict safety requirements due to its potential teratogenicity (fetal harm) and systemic effects. Our quality control system ensures efficacy and minimizes risks:

Raw Material Sourcing: Uses high-purity vitamin A derivatives as starting materials, with advanced synthesis processes to avoid isomerization (e.g., conversion to all-trans retinoic acid) and impurities that may increase toxicity.

Production Process: Manufactured in GMP-certified workshops with dedicated lines (to prevent cross-contamination with other pharmaceuticals), strict control over temperature and light (to avoid degradation), and precise crystallization to ensure product stability.

Testing Protocols: Each batch undergoes rigorous testing, including:

HPLC analysis for purity, isomer content (all-trans isomer ≤2.0%), and related substances.

Melting point determination (174-178°C).

Heavy metal (Pb, Hg, Cd) and microbial limit testing (to meet oral pharmaceutical standards).

Critical Safety Reminders:

Teratogenicity: Absolutely contraindicated in pregnant women or women of childbearing age without strict contraception (e.g., dual methods of birth control 1 month before, during, and 1 month after treatment). Pregnancy testing is mandatory before and during therapy.

Systemic Side Effects: May cause dry skin/mucous membranes (common), elevated liver enzymes, lipid abnormalities (cholesterol, triglycerides), and rare but serious effects (e.g., depression, intracranial hypertension). Regular medical monitoring is required.

Drug Interactions: Avoid concurrent use with vitamin A supplements (risk of hypervitaminosis A) and tetracycline antibiotics (increased intracranial hypertension risk).

Cooperation & Contact

We supply pharmaceutical-grade Isotretinoin raw materials exclusively for licensed pharmaceutical manufacturers producing oral acne treatments. We offer flexible capacities (from gram-level R&D samples to kilogram-level bulk orders) and strictly adhere to regulatory requirements for controlled dermatological medications. If you are a pharmaceutical enterprise or research institution in need of this product, please contact us for:

Detailed pharmacopoeia compliance documents and safety data sheets (SDS).

Pricing, bulk order terms, and sample requests (subject to regulatory approval).

Technical support (e.g., formulation stability, storage conditions).

Contact Information:

Email: sales@huarongpharma.com

Phone/WhatsApp: +86 13751168070

We uphold the principles of "quality first, patient safety" and look forward to establishing compliant, long-term cooperative relationships with global pharmaceutical partners!

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