Naproxen Enteric-Coated Tablets (250 mg / 500 mg)
Healthy Inc is a specialized global supplier and exporter of advanced orthopedic, rheumatology, and anti-inflammatory therapeutics. We provide ultra-high-purity, kinetically stabilized Naproxen Enteric-Coated / Film-Coated Tablets (250 mg / 500 mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Cardioprotective, Long-Acting NSAID” is a massive-volume, highly lucrative export to rheumatology centers, orthopedic clinics, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, long-term intervention for severe Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, and acute musculoskeletal trauma.
Product Overview
This highly advanced formulation contains Naproxen, a potent propionic acid derivative that delivers profound, sustained reductions in systemic inflammation and pain, acting as the foundational therapy for chronic, debilitating joint diseases.
The “Cardio-Safe & 12-Hour Relief” Specialist:
- Mechanism 1 (The COX-1 & COX-2 Blockade): Joint destruction in arthritis is driven by a massive overproduction of prostaglandins (the body’s inflammatory chemicals). Naproxen violently penetrates the inflamed joint capsule and aggressively inhibits the Cyclooxygenase (COX-1 and COX-2) enzymes. By shutting down this specific chemical pathway, it stops the production of prostaglandins at the source, rapidly eliminating swelling, stiffness, and agonizing joint pain.
- Mechanism 2 (The Cardioprotective Advantage – CRITICAL): Heavy, long-term use of standard NSAIDs (like Diclofenac or Ibuprofen) is notoriously associated with an increased risk of fatal myocardial infarctions (heart attacks) and strokes. Massive global clinical trials have proven that Naproxen has the lowest cardiovascular toxicity profile of any NSAID. It is the absolute gold-standard, globally mandated choice for treating severe arthritis in elderly patients with pre-existing heart disease.
- Mechanism 3 (The 12-Hour Pharmacokinetic Profile): Standard Ibuprofen requires patients to swallow pills every 4 to 6 hours to keep pain at bay. Naproxen possesses an exceptionally long half-life, providing profound, unbroken pain relief for a full 12 hours. This convenient twice-daily dosing guarantees patient compliance and allows chronic pain sufferers to sleep through the night without waking up in agony.
Product Composition & Strength
We supply this product as a Precision-Engineered Enteric-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-PVC or Alu-Alu blister strips to ensure the absolute chemical stability of the active ingredient and the protective polymer matrix.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Naproxen USP/Ph.Eur. | 250 mg (EC) | Initiation / Mild Standard: Base therapeutic unit for mild musculoskeletal trauma, acute gout, and primary dysmenorrhea. |
| Naproxen USP/Ph.Eur. | 500 mg (EC) | Global Rheumatology Standard: High-dose adult maintenance therapy for severe Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis. |
| Excipients | Methacrylic Acid Copolymer / Microcrystalline Cellulose / Croscarmellose Sodium / Povidone K30 / Triethyl Citrate / Magnesium Stearate | pH-Dependent Enteric Barrier / Diluent / Superdisintegrant / Plasticizer (Engineered specifically to absolutely block dissolution in the highly acidic stomach, preventing mucosal burns, and rapidly dissolving only in the alkaline duodenum) |
*Pack Sizes: 10×10 Blisters or Bottles of 100/500 (Optimized specifically for strict chronic orthopedic dispensing regimens and massive government health tenders).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Orthopedic Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Analgesics/Anti-inflammatories) |
| CAS Number | 22204-53-1 (Naproxen) |
| Dosage Form | Gastro-Resistant / Enteric-Coated Tablet (EC) |
| Packaging | High-Density Alu-PVC or Alu-Alu Blisters. Protects the delicate enteric polymer coating from environmental humidity and prevents chemical degradation across Zone IVb tropical climates. |
| Storage | Store strictly below 30°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.
- Fluid-Bed Enteric Coating Engineering (CRITICAL COMPLIANCE): The greatest barrier to long-term NSAID therapy is severe gastrointestinal bleeding caused by the drug dissolving directly against the stomach wall. Our facilities utilize advanced Wurster fluid-bed processors to spray a flawless, uniform layer of Methacrylic Acid Copolymer over every tablet. This strict pH-dependent shield remains absolutely intact in stomach acid (pH 1.2) but dissolves violently the moment it reaches the alkaline intestines (pH 6.8), completely protecting the patient’s stomach from direct chemical mucosal injury.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of severe, acute, and chronic inflammatory conditions:
- Rheumatoid Arthritis & Osteoarthritis: Relief of the signs and symptoms of chronic joint destruction.
- Ankylosing Spondylitis: Management of severe, progressive spinal inflammation.
- Acute Gout: Rapid suppression of intense, crystal-induced joint inflammation.
- Primary Dysmenorrhea: Relief of severe, incapacitating menstrual cramps.
Dosage & Administration
Recommended Dosage (Strictly as per Physician Guidelines):
- Chronic Arthritis: 500 mg to 1000 mg daily, given in two divided doses (every 12 hours).
- Acute Gout: Initial dose of 750 mg, followed by 250 mg every 8 hours until the attack subsides.
- Administration (THE MEALTIME RULE): To further minimize systemic GI irritation, tablets must always be taken with or immediately after food and a full glass of water.
- The Intact Rule: Enteric-coated tablets must be swallowed completely whole. Chewing or crushing physically destroys the protective enteric coating, exposing the stomach to severe ulceration.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- BLACK BOX WARNING (Cardiovascular Risk): While possessing the lowest risk in its class, all NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke. It is strictly contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
- BLACK BOX WARNING (Gastrointestinal Bleeding): NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and fatal perforation of the stomach or intestines. This risk is highest in elderly patients.
- Severe Renal Impairment: Prostaglandins are required to keep blood flowing to the kidneys. By blocking prostaglandins, Naproxen can severely drop renal blood flow, causing acute, catastrophic kidney failure. Use with extreme caution in patients with pre-existing renal disease or those on heavy diuretics.
- Aspirin-Sensitive Asthma: Strictly contraindicated in patients who have experienced severe asthma, urticaria, or allergic-type reactions after taking Aspirin or other NSAIDs, as it can trigger a fatal bronchospastic attack.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Orthopedic Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Analgesic and Enteric-Coated Formulations. Whether you are looking for a reliable Government Tender Supplier for arthritis clinics in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.