Description

Dapagliflozin Film-Coated Tablets (5 mg / 10 mg)

Healthy Inc is a specialized global supplier and exporter of advanced endocrinology, cardiology, and targeted cardio-renal-metabolic (CRM) therapeutics. We provide ultra-high-purity, kinetically stabilized Dapagliflozin Film-Coated Tablets (5 mg / 10 mg), manufactured in WHO–GMP certified, strictly humidity-controlled oral solid dosage facilities. This “Next-Generation SGLT2 Inhibitor” is a massive-volume, highly strategic export to cardiology networks, nephrology centers, diabetes clinics, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, apex intervention for Type 2 Diabetes, Heart Failure with Reduced Ejection Fraction (HFrEF), and Chronic Kidney Disease (CKD).

Product Overview

This highly advanced formulation operates as a multi-organ bio-mechanical modifier. Instead of relying on insulin to lower blood sugar, it physically alters the kidneys’ filtration threshold, forcing the body to excrete toxic excess glucose, sodium, and fluid directly into the urine, simultaneously rescuing the heart and protecting the renal nephrons.

The “Cardio-Renal-Metabolic & SGLT2 Blockade” Specialist:

• Mechanism 1 (The Glucosuric Drive – Diabetes): In a healthy human, the Sodium-Glucose Cotransporter 2 (SGLT2) in the proximal tubule of the kidney reabsorbs 90% of filtered glucose back into the blood. Dapagliflozin violently and selectively blocks this transporter. This instantly forces the kidneys to excrete up to 70 grams of glucose per day directly into the urine (glycosuria), profoundly lowering HbA1c, driving weight loss, and reducing blood pressure without causing hypoglycemia.
• Mechanism 2 (Myocardial Energetics – Heart Failure): By inducing mild osmotic diuresis and natriuresis (excreting sodium), Dapagliflozin drastically reduces both ventricular preload and afterload. Furthermore, it shifts the heart’s metabolism away from inefficient glucose utilization toward highly efficient ketone bodies, significantly reducing cardiovascular mortality and hospitalization for heart failure.
• Mechanism 3 (Glomerular Decompression – CKD): In failing kidneys, high pressure destroys the delicate filtration units (glomeruli). Dapagliflozin triggers tubuloglomerular feedback, which physically constricts the afferent arteriole entering the glomerulus. This instantly drops the intraglomerular pressure, halting the leakage of protein (albuminuria) and dramatically slowing the progression of end-stage renal disease (ESRD).

Technical & Logistics Specifications

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

Manufacturing Authority

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

• Polymorphic Stability & Moisture Defense (CRITICAL COMPLIANCE): The engineering challenge of Dapagliflozin lies in its crystalline structure. If generic manufacturers expose the API to high humidity or excessive heat during wet granulation, the drug undergoes a polymorphic shift, instantly destroying its bioavailability. Our CRM suites operate under strict climate control (RH < 30%) utilizing anhydrous excipients and advanced dry-blending/compaction techniques to guarantee 100% crystalline integrity and flawless clinical bioequivalence.

Therapeutic Indications (Human Use)

Indicated for the targeted, highly specialized lifelong management of Cardio-Renal-Metabolic disorders:

• Type 2 Diabetes Mellitus: Adjunct to diet and exercise to improve glycemic control.
• Heart Failure (HFrEF & HFpEF): To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults.
• Chronic Kidney Disease (CKD): To reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults at risk of progression.

Dosage & Administration

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

• Standard Adult Dosing: 10 mg taken orally once daily in the morning.
• Administration: Can be taken with or without food. Tablets must be swallowed whole.
• Volume Status Assessment: Before initiating, the patient’s volume status must be assessed and corrected if they are dehydrated, as the drug induces osmotic diuresis.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Euglycemic Diabetic Ketoacidosis (euDKA) [FATAL WARNING]: SGLT2 inhibitors can trigger severe, life-threatening diabetic ketoacidosis even when the patient’s blood sugar is completely normal. If a patient experiences nausea, vomiting, or severe abdominal pain, therapy must be halted instantly and ketones assessed.
• Genital Mycotic Infections: Because the drug floods the urinary tract with raw glucose, it creates a perfect breeding ground for severe yeast infections (vulvovaginal candidiasis in women, balanitis in men). Strict personal hygiene must be counseled.
• Fournier’s Gangrene: Rare but catastrophic necrotizing fasciitis of the perineum has been reported. Any pain, redness, or swelling in the genital area accompanied by a fever requires immediate surgical intervention.
• Volume Depletion & Hypotension: The massive diuretic effect can cause sudden, dangerous drops in blood pressure, acute kidney injury, and syncope, particularly in the elderly or those taking loop diuretics.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Cardiology/Nephrology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced SGLT2 Inhibitors, Cardio-Renal Therapeutics, and Moisture-Shielded Formulations. Whether you are looking for a reliable Government Tender Supplier for diabetes clinics in the CIS or a B2B Pharma Marketplace partner for Latin America, our highly regulated logistics network ensures timely, secure delivery of WHO-GMP certified products.