Gabapentin & Methylcobalamin Film-Coated Tablets (300 mg / 500 mcg)
Healthy Inc is a specialized global supplier and exporter of advanced neurology, diabetology, and complex multi-API FDC therapeutics. We provide ultra-high-purity, kinetically synchronized Gabapentin & Methylcobalamin (Mecobalamin) Film-Coated Tablets, manufactured in WHO–GMP certified, high-precision, photostable oral solid dosage facilities. This “Neuromodulator & Myelin-Regenerator FDC” is a massive-volume, highly lucrative export to neurology centers, diabetic care networks, pain management clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, dual-action intervention for severe diabetic peripheral neuropathy, sciatica, and alcoholic neuropathy.
Product Overview
This highly advanced formulation fundamentally attacks chronic nerve damage on two completely different biological fronts. While the Gabapentin acts as a chemical “circuit breaker” to instantly stop agonizing pain signals, the massive dose of biologically active Vitamin B12 works continuously in the background to physically rebuild the destroyed nerve tissue.
The “Pain Blockade & Structural Remyelination” Specialist:
- Mechanism 1 (The Ascending Pain Blockade – Gabapentin): In diabetic neuropathy, high blood sugar physically destroys the protective coating of the nerves, causing them to “short circuit” and send continuous, agonizing burning sensations to the brain. Gabapentin aggressively binds to the alpha-2-delta subunit of voltage-gated calcium channels on these misfiring nerves. By blocking calcium influx, it physically stops the nerve from releasing excitatory neurotransmitters, instantly choking off the pain signals.
- Mechanism 2 (The Structural Nerve Repair – Methylcobalamin): Methylcobalamin is the neurologically active, coenzyme form of Vitamin B12. Unlike standard cyanocobalamin, it bypasses the liver and directly enters the cerebrospinal fluid. It acts as a massive methyl-donor in the transmethylation reaction, massively accelerating the synthesis of proteins and lipids required to rebuild the myelin sheath (the nerve’s protective insulation) and promoting axonal regeneration.
- The “Symptom + Cure” Synergy: Monotherapy with painkillers leaves the underlying nerve damage untouched, guaranteeing the disease will worsen. By combining a potent neuromodulator with an aggressive structural repair agent, this FDC provides immediate symptomatic relief while actively working to reverse the underlying pathology of the neuropathy.
Product Composition & Strength
We supply this product as a Precision-Blended, Photostable FDC Tablet, packed exclusively in highly secure, light-blocking Alu-Alu blister strips to ensure the absolute chemical survival of the ultra-fragile B12 molecule.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Gabapentin USP/Ph.Eur. | 300 mg / 400 mg | The Neuromodulator (Macro-Dose): The foundational calcium-channel inhibitor required to stabilize hyperactive nerve terminals and stop the shooting pain. |
| Methylcobalamin (Mecobalamin) JP/USP | 500 mcg / 1500 mcg | The Myelin Regenerator (Micro-Dose): The highly potent, biologically active B12 analogue required to stimulate axonal growth and rebuild the damaged myelin sheath. |
| Excipients | Microcrystalline Cellulose / Croscarmellose Sodium / Copovidone / Colloidal Silicon Dioxide / Magnesium Stearate / Premium Titanium-Dioxide Film | Diluent / Superdisintegrant / Binder / Glidant / Film-Coating (Engineered utilizing strictly segregated blending or Bilayer technology to prevent the massive Gabapentin dose from degrading the microscopic Methylcobalamin, finished with a heavy, opaque film-coat to act as an absolute UV/Light barrier) |
*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict 3-to-6 month chronic diabetic and neurology dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Neurology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Neurology/Neuropathy FDC) |
| CAS Numbers | 60142-96-3 (Gabapentin) / 13422-55-4 (Methylcobalamin) |
| Dosage Form | Film-Coated Tablet (Immediate Gastric Release – Photostable) |
| Packaging | High-Density Alu-Alu Blisters (STRICTLY MANDATORY). Methylcobalamin is intensely photolabile and hygroscopic. Standard blister packaging will cause the API to rapidly degrade into inactive cobalamin. Strict Alu-Alu barrier packaging guarantees absolute chemical stability across Zone IVb tropical climates. |
| Storage | Store strictly below 25°C in a dry place. Protect heavily from Moisture and Direct Light. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Photostable Engineering & Micro-Dose Uniformity (CRITICAL COMPLIANCE): The engineering challenge of this specific FDC is massive. Methylcobalamin is notoriously unstable when exposed to light, heat, and moisture during standard wet granulation. Our facilities utilize advanced dry-blending and heavy Titanium Dioxide film-coating to create an impenetrable “dark room” inside the tablet. Furthermore, seamlessly blending a microscopic 500 mcg dose of B12 into a massive 300 mg dose of Gabapentin requires elite geometric dilution validated by intensive HPLC batch-testing. We guarantee total clinical potency and absolute content uniformity.
Therapeutic Indications (Human Use)
Indicated for the targeted, highly specialized management of severe, degenerative nerve damage:
- Diabetic Peripheral Neuropathy: Aggressive management of burning, shooting pain, and numbness in the extremities of patients with long-standing diabetes.
- Alcoholic Neuropathy: Structural repair of peripheral nerves destroyed by chronic alcohol toxicity and nutritional deficiency.
- Sciatica & Radiculopathy: Co-management of radiating nerve pain and numbness caused by spinal compression or injury.
- Postherpetic Neuralgia: Management of severe, lingering nerve damage following a Herpes Zoster (Shingles) infection.
Dosage & Administration
Recommended Dosage (Strictly as per Neurologist Guidelines):
- Standard Adult Dosing: Typically initiated as one tablet taken two to three times daily, depending on the severity of the neuropathy.
- Administration: Can be taken with or without food. Tablets should be swallowed whole.
- Renal Clearance Rule (CRITICAL): Because Gabapentin is excreted 100% unchanged by the kidneys, patients with severe renal impairment (low eGFR) must have their dose drastically reduced to prevent toxic neurological depression.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Fatal Respiratory Depression (FDA Warning): Co-administration of Gabapentin with CNS depressants (specifically Opioids like Tramadol) or use in patients with severe COPD can trigger profound, fatal respiratory depression.
- Withdrawal Seizures (The Tapering Mandate): Abruptly stopping this FDC can trigger continuous, life-threatening seizures (due to Gabapentin withdrawal). The drug must be tapered slowly.
- Severe Somnolence & Dizziness: Patients must be explicitly warned not to drive or operate heavy machinery until they know how the drug affects them, as extreme drowsiness is a primary side effect.
- Suicidal Behavior and Ideation: Gabapentin increases the risk of suicidal thoughts or behavior. Psychiatric monitoring is recommended during initiation.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Neurology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Neuropathic FDCs, Myelin-Regenerators, and Photostable Tableting Formulations. Whether you are looking for a reliable Government Tender Supplier for diabetic clinics in the CIS or a B2B Pharma Marketplace partner for Southeast Asia, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.