Description
Methoxsalen (Psoralen) Tablets / Soft Gelatin Capsules (10 mg)
Healthy Inc is a specialized global supplier and exporter of advanced dermatological, auto-immune, and photo-chemotherapy therapeutics. We provide ultra-high-purity, kinetically precise Methoxsalen Tablets and Capsules (10 mg), manufactured in WHO–GMP certified, high-precision immediate-release oral solid dosage facilities. This “Systemic Photo-Sensitizing Psoralen” is an ultra-high-value, specialized export to dermatology centers, phototherapy clinics, oncology networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for severe, treatment-resistant Psoriasis, extensive Idiopathic Vitiligo, and Cutaneous T-Cell Lymphoma (CTCL).
Product Overview
This highly advanced formulation utilizes a naturally derived, photoactive compound that fundamentally alters how human skin reacts to ultraviolet light. It is one-half of the globally renowned PUVA (Psoralen + UVA) Therapy protocol.
The “DNA-Crosslinking & Melanocyte-Stimulating” Specialist:
- Mechanism 1 (The Psoralen DNA Intercalation): In severe psoriasis, skin cells multiply at a violent, uncontrollable rate, creating thick, bleeding, scaly plaques. When Methoxsalen is swallowed, it circulates and passively slips between the base pairs of DNA (intercalation) inside these hyperactive epidermal cells. Without light, it sits dormant.
- Mechanism 2 (The UVA Activation & Apoptosis): Exactly 2 hours after taking the tablet, the patient stands in a calibrated UVA light booth. The UVA radiation strikes the skin, instantly “igniting” the dormant Methoxsalen. The activated drug forms permanent, covalent bonds (cross-links) with the DNA’s pyrimidine bases. This permanently cripples the DNA, completely halting the hyperproliferation of the psoriatic cells and clearing the skin.
- Mechanism 3 (Vitiligo Re-Pigmentation): In patients with Vitiligo (who have lost their skin pigment), PUVA therapy induces a completely different response. The Methoxsalen-UVA reaction causes a massive inflammatory cascade that stimulates the remaining, deep-tissue melanocytes. These pigment cells are forced to replicate and migrate upward into the epidermis, actively repigmenting the white patches of skin over several months of therapy.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Dermatology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Dermatologicals/Sensitizers) |
| CAS Number | 298-81-7 (Methoxsalen) |
| Dosage Form | Uncoated / Film-Coated Tablet OR Soft Gelatin Capsule |
| Packaging | Light-Blocking Alu-PVC, Alu-Alu, or Amber Bottles (STRICTLY MANDATORY). Methoxsalen reacts to ambient UV light. Packaging must form an impenetrable light barrier to prevent the API from chemically degrading before it reaches the patient. |
| Storage | Store strictly below 25°C in a dry place. Protect heavily from Moisture and Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Peak-Plasma Dissolution Engineering (CRITICAL COMPLIANCE): The clinical success of PUVA therapy relies 100% on timing. If a cheap generic tablet suffers from delayed gastric emptying, the patient will receive UVA radiation *before* the drug is in their skin. Then, hours later, when the drug finally absorbs, the patient will suffer massive, agonizing sunburns if they walk outside. Our facilities utilize advanced micronization and high-shear wet granulation (or PEG-based softgels) to guarantee a flawless, rapid pharmacokinetic spike, ensuring the patient’s peak blood levels perfectly align with their scheduled hospital UVA session.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of severe dermatological and autoimmune disorders in combination with UVA radiation:
- Severe, Recalcitrant Psoriasis: Management of disabling, widespread psoriasis that has not responded to topical therapies or standard systemic treatments.
- Idiopathic Vitiligo: Repigmentation of skin in patients with severe, widespread loss of melanocytes.
- Cutaneous T-Cell Lymphoma (CTCL): Palliative control of skin manifestations in specific blood cancers (often via extracorporeal photopheresis).
Dosage & Administration
Recommended Dosage (Strictly as per Dermatologist/Phototherapist Guidelines):
- Standard Adult Dosing: Strictly weight-based (usually 10 mg to 50 mg per session).
- The “2-Hour Window” Rule (CRITICAL): The dose MUST be taken exactly 1.5 to 2 hours prior to UVA exposure.
- Administration: Must be taken with food or milk. Methoxsalen causes violent, severe nausea in almost all patients if taken on an empty stomach.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Severe Phototoxicity & 3rd-Degree Burns): For 24 to 48 hours after swallowing the pill, the patient’s entire body is hyper-sensitive to ultraviolet light. Exposure to natural sunlight, even through a car window, can cause catastrophic, life-threatening 3rd-degree burns and severe blistering. Patients must wear fully covering clothing and broad-spectrum sunscreen when leaving the clinic.
- BLACK BOX WARNING (Ocular Toxicity & Cataracts): Methoxsalen binds to proteins in the lens of the eye. If the eyes are exposed to UVA light, irreversible cataracts will form. Patients must wear wrap-around, UVA-blocking sunglasses for a full 24 hours following the dose, both indoors (near windows) and outdoors.
- Skin Cancer Risk: Long-term PUVA therapy massive increases the risk of basal cell carcinoma, squamous cell carcinoma, and malignant melanoma. Constant dermatological surveillance is required.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Dermatology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Dermatological, Autoimmune, and Photo-Sensitizing Formulations. Whether you are looking for a reliable Government Tender Supplier for vitiligo clinics in the Middle East or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.








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