Description
L-Methylfolate Calcium, Pyridoxal-5-Phosphate & Mecobalamin Tablets
Healthy Inc is a specialized global supplier and exporter of advanced neurology, cardiology, and metabolic-support therapeutics. We provide ultra-high-purity, kinetically stabilized L-Methylfolate Calcium, Pyridoxal-5-Phosphate (P5P), & Mecobalamin Film-Coated Tablets (1mg / 0.5mg / 1500mcg), manufactured in WHO–GMP certified, highly specialized, light-and-moisture controlled oral solid dosage facilities. This “Triple-Active Coenzyme Homocysteine Eradicator” is a premium, high-margin export to neurology centers, diabetic care clinics, advanced cardiovascular networks, and high-end retail pharmacies in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, elite intervention for Diabetic Neuropathy, Hyperhomocysteinemia, and patients with compromised MTHFR enzymatic pathways.
Product Overview
This highly advanced Fixed-Dose Combination (FDC) utilizes the pre-converted, biologically active forms of Vitamins B9, B6, and B12. It fundamentally bypasses the liver’s metabolic bottleneck, ensuring 100% cellular utilization even in patients with severe hepatic impairment or genetic mutations.
The “MTHFR-Bypass & Direct-Action” Specialist:
- Mechanism 1 (The MTHFR Bypass – L-Methylfolate Calcium): Standard Folic Acid must undergo a complex, 4-step conversion process in the liver, driven by the MTHFR enzyme, to become active. Millions of patients have a genetic mutation that cripples this enzyme. L-Methylfolate is the *already active* form. It crosses the blood-brain barrier immediately to synthesize monoamines (serotonin, dopamine, norepinephrine) and acts as the primary methyl-donor to neutralize toxic homocysteine.
- Mechanism 2 (The Transsulfuration Catalyst – Pyridoxal-5-Phosphate): Standard Vitamin B6 (Pyridoxine HCl) must be phosphorylated in the liver. In sick or elderly patients, this process fails. P5P is the active coenzyme. It instantly activates the transsulfuration pathway, acting as the master catalyst to flush toxic homocysteine out of the body while synthesizing essential neurotransmitters to restore healthy nerve signaling.
- Mechanism 3 (The Myelin Rebuilder – Mecobalamin): While standard Cyanocobalamin creates a toxic cyanide byproduct that the body must clear, Mecobalamin is the neurologically active coenzyme. It violently accelerates the synthesis of neuronal lipids, physically rebuilding the stripped myelin sheath around damaged peripheral nerves, permanently stopping the burning and numbness associated with severe diabetic neuropathy.
Product Composition & Strength
We supply this product as a Precision-Blended, Photostable Film-Coated Tablet, packed exclusively in highly secure, light-blocking Alu-Alu blister strips to ensure the absolute chemical survival of the three delicate coenzymes.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| L-Methylfolate Calcium USP/Ph.Eur. | 1 mg | Active Vitamin B9: Direct methyl-donor for homocysteine remethylation and massive neurotransmitter synthesis. |
| Pyridoxal-5-Phosphate (P5P) USP/Ph.Eur. | 0.5 mg | Active Vitamin B6: Immediate catalyst for transsulfuration; drastically reduces the risk of paradoxical sensory neuropathy seen with cheap Pyridoxine. |
| Mecobalamin (Methylcobalamin) USP/Ph.Eur. | 1500 mcg | Active Vitamin B12: Direct peripheral nerve repair, myelin synthesis, and essential co-factor for homocysteine neutralization. |
| Excipients | Microcrystalline Cellulose / Croscarmellose Sodium / Magnesium Stearate / Titanium Dioxide / Premium Opaque Opadry Film | Diluent / Superdisintegrant / Lubricant / Heavy UV-Blocking Coating (Engineered specifically to form an impenetrable light barrier, completely preventing the photolabile degradation of the active B12 and folate components) |
*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict, 3-to-6 month chronic neurology and diabetic dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Neurology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.50.90 (Medicaments containing vitamins or derivatives – Advanced Neurology FDC) |
| CAS Numbers | 151533-22-1 (L-Methylfolate Calcium) / 54-47-7 (P5P) / 13422-55-4 (Mecobalamin) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release) |
| Packaging | Heavy-Gauge Alu-Alu Blisters (STRICTLY MANDATORY). Active coenzymes are exceptionally sensitive to UV light, oxygen, and moisture. Strict Alu-Alu barrier packaging guarantees absolute chemical stability and full tri-active potency across Zone IVb tropical climates. |
| Storage | Store strictly below 25°C in a dry place. Protect heavily from Light and Moisture. Keep inside the outer carton until use. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Active Coenzyme Stabilization & pH-Buffering (CRITICAL COMPLIANCE): Compounding three highly reactive coenzymes into a single, stable oral solid dosage form is a massive technical challenge. If exposed to standard moisture or incorrect internal pH, P5P and L-Methylfolate will rapidly cross-react and degrade. Our specialized neurology suites utilize advanced dry-blending techniques under strict climatic controls, incorporating precise pH buffers. Combined with an immediate titanium-dioxide opaque film coating applied under amber lighting, we guarantee 100% of the active metabolic payload survives the shelf-life and reaches the patient intact.
Therapeutic Indications (Human Use)
Indicated for the targeted, multi-pathway management of severe neurological, vascular, and metabolic disorders:
- Diabetic & Peripheral Neuropathy: Aggressive repair of nerve damage, alleviating numbness, tingling, and burning pain in the extremities, especially in patients unresponsive to standard vitamins.
- Hyperhomocysteinemia & Endothelial Dysfunction: Massive reduction of toxic homocysteine levels to prevent arterial stiffening, stroke, and ischemic heart disease.
- MTHFR Polymorphism: The mandated dietary management for patients with confirmed genetic defects in the methylenetetrahydrofolate reductase enzyme.
- Major Depressive Disorder (MDD) Augmentation: Frequently prescribed alongside SSRIs/SNRIs by psychiatrists. Because L-Methylfolate crosses the blood-brain barrier instantly, it provides the essential raw materials needed for the brain to produce serotonin and dopamine.
- High-Risk Pregnancy: To ensure proper neural tube development in expecting mothers with known folate-metabolism defects.
Dosage & Administration
Recommended Dosage (Strictly as per Physician Guidelines):
- Standard Adult Dosing: One tablet taken orally once or twice daily. For severe neuropathy, therapy must be continued for a minimum of 3 to 6 months to allow for physical nerve regrowth.
- Administration: Can be taken with or without food. Tablets must be swallowed whole with water.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Levodopa Interaction (Parkinson’s Disease Alert): Even in its active P5P form, Vitamin B6 can accelerate the peripheral metabolism of Levodopa, preventing it from reaching the brain. This FDC should NOT be given to Parkinson’s patients taking standalone Levodopa (permissible if taking Levodopa combined with Carbidopa).
- Bipolar Disorder Caution: Because L-Methylfolate drastically increases the synthesis of monoamines (dopamine/serotonin), it can theoretically trigger a manic episode in patients with undiagnosed Bipolar Disorder if used as a standalone psychiatric treatment.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Neurology/Cardiology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Neurological, Diabetic-Support, and Active-Coenzyme Formulations. Whether you are looking for a reliable Private Label Supplier for specialized 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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