Description
Pregabalin SR & Methylcobalamin Tablets (75 mg / 1500 mcg)
Healthy Inc is a specialized global supplier and exporter of advanced neurology, diabetology, and central nervous system (CNS) therapeutics. We provide ultra-high-purity, kinetically synchronized Pregabalin Sustained-Release (SR) & Methylcobalamin Film-Coated Tablets (75 mg / 1500 mcg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Neuromodulator & Remyelination Synergy” is a highly lucrative, massive-volume export to diabetic care centers, neurology clinics, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, once-daily intervention for severe Diabetic Peripheral Neuropathy (DPN) and chronic nerve damage.
Product Overview
This highly advanced Fixed-Dose Combination masterfully synchronizes a powerful nerve-calming gabapentinoid with a high-dose, neurologically active Vitamin B12 coenzyme, delivering complete 24-hour pain control while actively repairing the underlying anatomical nerve damage.
The “Symptom Control & Anatomical Repair” Specialist:
- Mechanism 1 (The Nerve Calmer – Pregabalin SR): In severe neuropathy, damaged nerves misfire continuously, causing agonizing burning and “electric shock” sensations. Pregabalin binds to the alpha-2-delta subunit of voltage-gated calcium channels in the CNS, violently shutting down the release of excitatory pain neurotransmitters. Crucially, our Sustained-Release (SR) Matrix slowly trickles the Pregabalin into the blood over 24 hours. This completely eliminates the sudden, massive drug spikes that cause extreme dizziness and fatigue in standard Pregabalin capsules, guaranteeing patient compliance.
- Mechanism 2 (The Nerve Rebuilder – Methylcobalamin 1500mcg): While Pregabalin stops the pain signals, Methylcobalamin (the neurologically active, readily absorbed form of Vitamin B12) targets the root cause. It aggressively upregulates the production of nucleic acids and proteins in nerve cells, physically accelerating the regeneration of the protective myelin sheath (remyelination) and restoring healthy axonal transport in nerves destroyed by high blood sugar or viral infections.
- The “Once-Daily” Diabetic Advantage: Diabetic patients frequently suffer from massive pill burdens. By combining 24-hour symptom relief with active nerve repair in a single, once-daily bedtime dose, this FDC drastically improves clinical outcomes and patient adherence.
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Diabetology Distributors, and Pharmacy Chains.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Neurology/Neuropathic Analgesics) |
| CAS Numbers | 148553-50-8 (Pregabalin) / 13422-55-4 (Methylcobalamin) |
| Dosage Form | Sustained-Release (SR) / Prolonged-Release Film-Coated Tablet |
| Packaging | Alu-Alu Blisters (STRICTLY MANDATORY). Methylcobalamin degrades extremely rapidly when exposed to UV light or moisture. Furthermore, the SR polymer matrix will swell prematurely if exposed to ambient humidity. Strict heavy-gauge Alu-Alu barrier packaging guarantees absolute therapeutic potency across Zone IVb tropical climates. |
| Regulatory Status | Controlled Substance Warning (Pregabalin): Export requires strict adherence to international narcotics control board (INCB) quotas and specialized import permits, depending on the destination country’s scheduling of Pregabalin. |
| Storage | Store strictly below 25°C in a dry place. Protect heavily from Light and Moisture. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Bilayer Matrix & Photosensitive Engineering: Formulating an SR Pregabalin matrix alongside a highly volatile 1500 mcg dose of Methylcobalamin is exceptionally difficult. Our facilities utilize advanced Bilayer Tableting technology or specialized coated-granule blending under strict amber-lit/UV-filtered environments. This guarantees that the B12 is fully protected from light degradation during manufacturing, while the Pregabalin is perfectly locked inside the HPMC hydro-gel matrix for flawless 24-hour zero-order release.
Therapeutic Indications (Human Use)
Indicated for the comprehensive anatomical and symptomatic management of severe nerve damage:
- Diabetic Peripheral Neuropathy (DPN): First-line treatment for pain and nerve degeneration in patients with long-standing diabetes.
- Post-Herpetic Neuralgia (PHN): Management of severe, lingering nerve pain following a shingles (Herpes Zoster) outbreak.
- Alcoholic & Trigeminal Neuropathy: Treatment of peripheral nerve damage induced by chronic alcoholism or facial nerve misfiring.
- Fibromyalgia & Spondylosis: Adjunctive management of widespread neuropathic and radicular (spinal root) pain syndromes.
Dosage & Administration
Recommended Dosage (Strictly as per Neurologist/Endocrinologist Guidelines):
- Standard Adult Dosing: One tablet (75 mg / 1500 mcg) taken orally once daily.
- Administration (THE BEDTIME & INTACT RULE): Because Pregabalin can cause mild somnolence (even in SR form), it is highly recommended to take the daily dose after the evening meal or at bedtime. The tablet MUST be swallowed completely whole with water. Chewing, crushing, or breaking the tablet instantly destroys the Sustained-Release matrix, causing a massive, toxic dump of Pregabalin into the bloodstream.
- Discontinuation: This medication must never be stopped abruptly to prevent withdrawal seizures and severe insomnia. It must be tapered over a minimum of one week.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Peripheral Edema & Weight Gain: Pregabalin frequently causes fluid retention and weight gain. It must be used with extreme caution in patients with congestive heart failure (NYHA Class III or IV) or concurrent use of thiazolidinedione antidiabetics (like Pioglitazone).
- Suicidal Behavior and Ideation: As an antiepileptic derivative, Pregabalin increases the risk of suicidal thoughts. Patients must be monitored for sudden mood changes or worsening depression.
- Respiratory Depression: Concomitant use with opioids or other central nervous system depressants can cause fatal respiratory failure.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Neurological and Diabetology Formulations. Whether you are looking for a reliable Government Tender Supplier for diabetes clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly regulated, WHO-GMP certified products.









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