Description

N-Acetylcysteine & Taurine Film-Coated Tablets (150 mg / 500 mg)

Healthy Inc is a specialized global supplier and exporter of advanced nephrology, hepatology, and metabolic-support therapeutics. We provide ultra-high-purity, kinetically stabilized N-Acetylcysteine & Taurine Film-Coated Tablets (150 mg / 500 mg), manufactured in WHO–GMP certified, high-precision modified-release oral solid dosage facilities. This “Dual-Action Renal Antioxidant & Osmoregulator” is an ultra-high-value, specialized export to nephrology centers, diabetic care clinics, internal medicine networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as a globally trusted, adjunctive intervention for Diabetic Nephropathy, Chronic Kidney Disease (CKD), and drug-induced hepatotoxicity.

Product Overview

This highly advanced Fixed-Dose Combination (FDC) masterfully synchronizes a profound glutathione-precursor with an essential intracellular amino acid. Together, they form an impenetrable shield against the oxidative free radicals and osmotic stress that silently destroy the micro-filters of the kidneys and liver.

The “Glomerular Shield & Oxidative Neutralizer” Specialist:

• Mechanism 1 (The Glutathione Engine – N-Acetylcysteine): In the diabetic kidney, high blood sugar creates massive amounts of Reactive Oxygen Species (ROS)—toxic “exhaust” that burns holes in the renal tubules, causing essential proteins to leak into the urine (microalbuminuria). N-Acetylcysteine acts as the direct, rate-limiting precursor to Glutathione, the body’s master antioxidant. It aggressively replenishes the kidneys’ glutathione reserves, chemically neutralizing the ROS and halting the inflammatory cascade before irreversible fibrosis occurs.
• Mechanism 2 (The Cellular Osmoregulator – Taurine): Taurine is the most abundant free amino acid in human tissue. In failing kidneys, fluctuating blood sugar and pressure cause the delicate kidney cells to swell, rupture, and die (apoptosis). Taurine acts as a profound cellular osmoregulator. It stabilizes the cell membranes of the glomeruli, regulates intracellular calcium, and prevents the physical deformation of the kidney’s filtration barrier.
• The Microalbuminuria Reversal: By combining the ROS-scavenging power of NAC with the structural protection of Taurine, this FDC directly targets the root pathology of early-stage diabetic kidney disease, significantly reducing protein leakage and slowing the dangerous progression toward end-stage renal failure and dialysis.

Product Composition & Strength

We supply this product as a Precision-Blended, Odor-Masked Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the highly hygroscopic and sulfurous active ingredients.

*Pack Sizes: 10×10 Alu-Alu Blisters (Optimized specifically for strict, chronic nephrology dispensing regimens).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Nephrology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Sulfur Odor-Masking & Ultra-Low Humidity Engineering (CRITICAL COMPLIANCE): The greatest barrier to oral NAC therapy is its overwhelming “rotten egg” smell and bitter taste, causing massive patient abandonment. Our facilities utilize advanced dry-blending in ultra-low humidity suites to prevent the API from absorbing ambient moisture and off-gassing. We then apply a specialized, multi-layered polymer film-coating—frequently integrating premium masking flavors—creating an impenetrable seal that traps the odor inside the tablet, guaranteeing a smooth, highly tolerable patient experience.

Therapeutic Indications (Human Use)

Indicated for the targeted, multi-pathway management of severe renal and metabolic dysfunction:

• Diabetic Nephropathy: Adjunctive therapy to reduce microalbuminuria, proteinuria, and oxidative stress in the kidneys of patients with Type 1 and Type 2 Diabetes.
• Chronic Kidney Disease (CKD): Long-term renal protection to slow the decline of Glomerular Filtration Rate (GFR).
• Contrast-Induced Nephropathy (Prophylaxis): Administered prior to and following radiological imaging procedures (like CT scans with iodine dye) to prevent acute kidney injury.
• Hepatic Support: Protection against drug-induced hepatotoxicity and oxidative liver damage.

Dosage & Administration

Recommended Dosage (Strictly as per Nephrologist Guidelines):

• Standard Adult Dosing: One tablet (150mg/500mg) taken orally twice or three times daily, depending on the severity of renal impairment.
• Administration (THE MEALTIME RULE): To drastically reduce the risk of severe gastric irritation, nausea, and dyspepsia caused by the amino acid derivatives, the tablets MUST be taken with or immediately after meals.
• The Intact Rule: Tablets must be swallowed completely whole. Breaking or chewing the tablet destroys the odor-masking coating, releasing a noxious sulfur smell and bitter taste.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Severe Gastrointestinal Distress: Oral NAC frequently causes nausea, vomiting, diarrhea, and severe heartburn. It must be used with caution in patients with a history of severe peptic ulcer disease.
• Asthma & Bronchospasm Caution: While primarily a risk with inhaled/nebulized NAC, severe asthmatics taking oral mega-doses must be monitored for sudden bronchospasm or chest tightness.
• Nitroglycerin Interaction: NAC massively amplifies the vasodilatory effects of Nitroglycerin. Concurrent use can cause sudden, severe, and potentially fatal hypotension and intractable headaches.
• Urine Discoloration / Odor: Patients should be advised that their urine may harmlessly take on a distinct sulfurous odor during therapy due to the renal excretion of NAC metabolites.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Nephrology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Metabolic, Renal, and Odor-Masked Formulations. Whether you are looking for a reliable Government Tender Supplier for diabetic 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.