Description

Sevelamer Carbonate Tablets (800 mg / 400 mg)

Healthy Inc is a specialized global supplier and exporter of advanced nephrological, dialysis-support, and metabolic therapeutics. We provide ultra-high-purity, pharmacopeially validated Sevelamer Carbonate Film-Coated Tablets (800 mg / 400 mg), manufactured in WHO–GMP certified, strictly climate-controlled oral solid dosage facilities. This “Non-Absorbed Polymeric Phosphate Binder” is a massive-volume, premium export to dialysis centers, elite nephrology networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, cardiovascular-sparing intervention for severe hyperphosphatemia in Chronic Kidney Disease (CKD).

Product Overview

This highly advanced formulation contains Sevelamer Carbonate, a sophisticated cross-linked polymer that works entirely within the digestive tract, never entering the patient’s bloodstream, to aggressively strip dangerous levels of phosphorus from the food they eat.

The “Cardiovascular-Sparing Phosphate Trapper” Specialist:

• Mechanism 1 (Dietary Phosphorus Trapping): Patients with failing kidneys cannot filter phosphorus out of their blood (hyperphosphatemia). This leads to severe bone disease, intense itching, and fatal hardening of the arteries. When taken with a meal, Sevelamer Carbonate physically binds to the phosphorus molecules in the food within the stomach and intestines. It locks the phosphorus into an insoluble complex that is simply excreted in the feces, preventing it from ever entering the bloodstream.
• Mechanism 2 (The Systemic Safety Advantage): Because Sevelamer is a massive, cross-linked polymer, it is completely unabsorbed by the human body. It does its job in the gut and leaves, meaning it has zero systemic toxicity and does not accumulate in the tissues, unlike older aluminum-based binders.
• The “Non-Calcium” Cardiovascular Shield: This is the ultimate clinical selling point. Older phosphate binders use calcium to trap phosphorus. However, flooding a dialysis patient with calcium causes their blood vessels to literally turn to bone (vascular calcification), leading to massive heart attacks and strokes. Sevelamer contains zero calcium and zero metal, aggressively protecting the patient’s cardiovascular system while managing their phosphorus levels.

Product Composition & Strength

We supply this product as a Precision-Compressed Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant heavy-gauge HDPE bottles to prevent the highly hygroscopic polymer from absorbing ambient humidity and expanding.

*Pack Sizes: Bottles of 30, 90, or 270 Tablets (Optimized specifically for strict, massive-volume daily dialysis regimens where patients consume multiple grams with every meal).

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.

• Hygroscopic Polymer Compression: Manufacturing an 800 mg dose of Sevelamer requires elite environmental control. If the relative humidity (RH) on the manufacturing floor is too high, the polymer will rapidly absorb water from the air and expand, ruining the batch. Our facilities utilize strictly controlled, ultra-low humidity environmental suites and high-compression rotary presses to guarantee absolute tablet integrity, structural hardness, and flawless gastrointestinal dispersion.

Therapeutic Indications (Human Use)

Indicated for the targeted correction of severe mineral and bone disorders in renal failure:

• Hyperphosphatemia in Dialysis: Control of serum phosphorus in patients with Chronic Kidney Disease (CKD) on hemodialysis or peritoneal dialysis.
• Hyperphosphatemia in Non-Dialysis CKD: Control of serum phosphorus in adult patients with CKD not on dialysis with serum phosphorus ≥ 5.5 mg/dL.

Dosage & Administration

Recommended Dosage (Strictly as per Nephrologist/Dietitian Guidelines):

• Standard Adult Dosing: The starting dose is usually 800 mg to 1600 mg taken with meals based on the patient’s baseline serum phosphorus level. Maintenance doses can exceed 6,000 mg to 8,000 mg per day.
• Administration (THE MEALTIME RULE): This drug is completely useless if taken on an empty stomach. It MUST be administered with meals to intercept and bind the phosphorus as the food breaks down.
• Swallowing Protocol (CRITICAL HAZARD): Tablets MUST be swallowed whole with a glass of water. They must never be crushed, chewed, or broken into pieces. Because the polymer rapidly expands when exposed to water, a broken tablet can swell in the esophagus and cause severe, life-threatening choking or esophageal obstruction.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Bowel Obstruction & Perforation Warning: Because Sevelamer is a massive, non-absorbed polymer, it can cause severe gastrointestinal issues, including bowel obstruction, ileus, fecal impaction, and rare cases of fatal gastrointestinal perforation. It must be used with extreme caution in patients with a history of bowel surgery, severe constipation, or swallowing disorders (dysphagia).
• Drug Interactions (The 1-to-3 Hour Rule): Because Sevelamer’s entire job is to aggressively bind to molecules in the gut, it will accidentally bind to and destroy the absorption of other life-saving oral medications. Critical drugs (like Ciprofloxacin, Levothyroxine, or anti-seizure medications) MUST be taken at least 1 hour before or 3 hours after the Sevelamer dose.
• Vitamin Deficiency: Long-term use can bind to and reduce the absorption of fat-soluble vitamins (A, D, E, and K) and folic acid. Dialysis patients usually require routine vitamin supplementation.

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 Retail Pharmacy Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Nephrological Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Hospital Tender Supplier for national dialysis 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.