Description
Pregabalin & Methylcobalamin Capsules
Healthy Inc is a specialized global supplier and exporter of advanced neurological, orthopedic, and diabetic-care therapeutics. We provide high-purity Pregabalin (75 mg / 150 mg) & Methylcobalamin (750 mcg / 1500 mcg) Capsules, manufactured in WHO–GMP certified, highly precise oral solid dosage facilities. This “Neuropathic Pain & Nerve Regeneration” synergy is a massive-volume, high-priority export to neurology centers, diabetic clinics, pain management hospitals, and government health ministries in LATAM, Southeast Asia, and Africa, serving as the gold-standard intervention for peripheral neuropathy, post-herpetic neuralgia, and severe sciatica.
Product Overview
This advanced formulation combines two highly synergistic neurological agents: Pregabalin (a potent gabapentinoid and alpha-2-delta ligand) and Methylcobalamin (the neurologically active, highly bioavailable form of Vitamin B12).
The “Pain Blockade & Nerve Repair” Specialist:
- Mechanism 1 (Pregabalin – The Pain Blocker): Pregabalin is a structural analogue of the inhibitory neurotransmitter GABA, though it does not bind directly to GABA receptors. Instead, it binds with high affinity to the alpha-2-delta (α2δ) subunit of voltage-gated calcium channels in the central nervous system. This blocks the influx of calcium, forcefully suppressing the release of excitatory neurotransmitters (like glutamate, norepinephrine, and substance P) that are misfiring in damaged nerves. This rapidly halts the burning, shooting, and electric-shock sensations of neuropathic pain.
- Mechanism 2 (Methylcobalamin – The Nerve Healer): While Pregabalin masks the pain, Methylcobalamin actively treats the underlying pathology. As a vital methyl donor, it drastically accelerates the synthesis of nucleic acids, proteins, and lipids inside the neuron. It actively promotes myelination (rebuilding the protective myelin sheath around the nerve) and stimulates axonal regeneration, restoring the physical integrity of the damaged peripheral nerves over time.
- The Synergistic Clinical Advantage: NSAIDs and traditional analgesics are completely ineffective against nerve pain. This FDC provides immediate symptomatic relief (via Pregabalin) while simultaneously reversing the nerve degradation (via Methylcobalamin) caused by chronic hyperglycemia (diabetes) or viral damage (shingles).
Product Composition & Strength
We supply this product as a Hard Gelatin Capsule, packed strictly in high-barrier Alu-Alu blister strips to preserve the highly unstable, light-sensitive Methylcobalamin component.
| Active Ingredient | Strength & Format | Release Profile Function |
|---|---|---|
| Pregabalin USP/BP | 75 mg / 150 mg | Alpha-2-delta ligand for aggressive suppression of neuropathic pain signals. |
| Methylcobalamin JP/USP | 750 mcg / 1500 mcg (Micrograms) | Active B12 coenzyme for profound nerve remyelination and axon repair. |
| Excipients | Microcrystalline Cellulose / Talc / Magnesium Stearate | Diluent / Glidant / Lubricant (Ensures microgram distribution uniformity) |
*Pack Sizes: 10×10 Alu-Alu Blisters or 10×15 Alu-Alu Blisters (optimizing for 30-day chronic neurology dispensing cycles).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers and Neurology Distributors.
| HS Code | 3004.90.99 (Medicaments containing other active substances) |
| CAS Numbers | 148553-50-8 (Pregabalin) / 13422-55-4 (Methylcobalamin) |
| Dosage Form | Hard Gelatin Capsule |
| Packaging | Alu-Alu Blister (CRITICAL). Methylcobalamin is intensely sensitive to light (photolysis) and moisture. Standard clear PVC packaging will result in rapid API degradation and complete loss of nerve-repair efficacy. |
| Storage | Store strictly below 25°C in a dry place. Protect from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Microgram (mcg) Assay Precision: Methylcobalamin is dosed in fractions of a milligram (mcg). Uneven blending causes “hot spots” leading to therapeutic failure. Our facilities utilize advanced geometric dilution and high-shear V-blenders, validated by stringent HPLC testing, to guarantee absolute content uniformity of the active Vitamin B12 across every single capsule.
- Photosensitive Handling Protocols: To prevent the photolytic breakdown of Methylcobalamin during manufacturing, encapsulation is performed under specialized sodium-vapor lighting (amber lighting) in humidity-controlled suites before being immediately sealed in opaque Alu-Alu foil.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of chronic neuropathic disorders:
- Diabetic Peripheral Neuropathy (DPN): Management of severe burning, tingling, and numbness in the hands and feet associated with chronic diabetes.
- Post-Herpetic Neuralgia (PHN): Treatment of the lingering, excruciating nerve pain following an outbreak of Herpes Zoster (Shingles).
- Sciatica & Radiculopathy: Relief of sharp, shooting pain radiating from the lower back down the legs due to nerve compression.
- Fibromyalgia: Adjunctive management of widespread musculoskeletal pain and hyperalgesia.
Dosage & Administration
Recommended Dosage (Strictly as per Neurologist/Physician):
- Administration: Taken orally, with or without food.
- Standard Adult Titration: Typically initiated at 75mg/750mcg once or twice daily. Based on efficacy and tolerability, the dose may be increased to 150mg/1500mcg twice daily.
- Discontinuation Protocol (CRITICAL): Pregabalin must NEVER be stopped abruptly. Sudden discontinuation can cause severe withdrawal symptoms, including severe insomnia, nausea, headache, anxiety, hyperhidrosis, and an increased risk of withdrawal seizures. The dose must be tapered gradually over a minimum of 1 week.
Safety Warnings (CRITICAL):
- CNS Depression & Dizziness: Pregabalin causes significant dose-dependent somnolence (sleepiness) and dizziness. Patients must not drive or operate heavy machinery until they understand how the drug affects them. Co-administration with alcohol, opioids, or benzodiazepines can lead to fatal respiratory depression.
- Weight Gain & Peripheral Edema: Pregabalin is associated with weight gain and peripheral edema (swelling of the hands/legs). It should be used with extreme caution in patients with congestive heart failure (CHF) class III or IV.
- Suicidal Behavior/Ideation: Like all antiepileptic drugs, Pregabalin carries an increased risk of suicidal thoughts or behavior. Patients should be strictly monitored for the emergence or worsening of clinical depression.
- Abuse Potential (Controlled Substance Note): In many jurisdictions (e.g., the US, UK), Pregabalin is classified as a controlled substance due to its potential for misuse, dependence, and euphoria at supra-therapeutic doses.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Neurological Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for government diabetic care programs in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.









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