Description
Saxagliptin Tablets (2.5 mg / 5 mg)
Healthy Inc is a specialized global supplier and exporter of advanced endocrinological, metabolic, and chronic-care therapeutics. We provide ultra-high-purity, kinetically stabilized Saxagliptin Film-Coated Tablets (2.5 mg / 5 mg), manufactured in WHO–GMP certified, high-precision oral solid dosage facilities. This “Dipeptidyl Peptidase-4 (DPP-4) Inhibitor” is a massive-volume, premium export to diabetology centers, internal medicine clinics, retail pharmacy networks, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the globally mandated, highly tolerable intervention for the glycemic management of Type 2 Diabetes Mellitus.
Product Overview
This formulation contains Saxagliptin, a highly selective, modern anti-diabetic agent that harnesses the body’s own natural incretin hormones to lower blood sugar only when it is actually elevated, providing a massive safety advantage over older therapies.
The “Glucose-Dependent Glycemic Controller” Specialist:
- Mechanism (The DPP-4 Blockade): When a person eats, the gut releases “incretin” hormones (like GLP-1 and GIP) that tell the pancreas to produce insulin and stop producing glucagon. Normally, an enzyme called DPP-4 rapidly destroys these hormones within minutes. Saxagliptin aggressively binds to and blocks the DPP-4 enzyme. This allows the natural incretin hormones to remain active in the blood for much longer, dramatically boosting insulin production in a highly controlled manner.
- The Weight-Neutral Advantage: Older diabetes drugs (like Glimepiride or Pioglitazone) are notorious for causing significant weight gain, which worsens the underlying insulin resistance. Saxagliptin is fundamentally weight-neutral, making it the preferred add-on therapy for overweight or obese Type 2 diabetics.
- The Hypoglycemia Shield: Because Saxagliptin only boosts insulin in response to food (glucose-dependent), the risk of a patient’s blood sugar crashing dangerously low (hypoglycemia) is exceptionally rare when used as a monotherapy or with Metformin.
Product Composition & Strength
We supply this product as a Precision-Blended Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu blister strips to ensure the absolute chemical stability of the sensitive active pharmaceutical ingredient.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Saxagliptin (as Hydrochloride) INN/Ph.Eur. | 2.5 mg | Target dose for patients with moderate/severe renal impairment or those taking strong CYP3A4 inhibitors. |
| Saxagliptin (as Hydrochloride) INN/Ph.Eur. | 5 mg | Global Clinical Standard: Maximum adult daily dose for the maintenance of Type 2 Diabetes. |
| Excipients | Lactose Monohydrate / Microcrystalline Cellulose / Croscarmellose Sodium / Magnesium Stearate | Diluent / Binder / Superdisintegrant (Engineered for immediate gastric dissolution and optimal bioavailability) |
*Pack Sizes: 10×10 Alu-Alu Blisters or 3×10 Unit-Dose Blisters (Optimized specifically for high-compliance 30-day chronic metabolic dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Endocrinology Distributors, and Pharmacy Chains.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antidiabetics) |
| CAS Number | 361442-04-8 (Saxagliptin) / 709031-78-7 (Saxagliptin Hydrochloride) |
| Dosage Form | Film-Coated Tablet (Immediate Release) |
| Packaging | Alu-Alu Blisters (STRICTLY MANDATORY). Protects the sensitive gliptin formulation from environmental humidity and hydrolytic degradation across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect from Light and Moisture. |
| Certificates | WHO-GMP, COPP, Free Sale Certificate |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Low-Dose Geometric Blending Engineering: Uniformly distributing a minute 2.5 mg or 5 mg dose of Saxagliptin throughout a standard tablet matrix requires elite pharmaceutical engineering. Our facilities utilize advanced high-shear homogenizers and strict geometric dilution protocols, verified by rigorous HPLC content uniformity testing, to guarantee that every single tablet delivers the exact milligram dose, completely eliminating the risk of sub-therapeutic failures in chronic diabetic patients.
Therapeutic Indications (Human Use)
Indicated for the targeted management of metabolic dysfunction:
- Type 2 Diabetes Mellitus: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. It can be used as monotherapy (in patients intolerant to Metformin) or as combination therapy with Metformin, Sulfonylureas, or Thiazolidinediones.
- CRITICAL LIMITATION: It is strictly NOT indicated for the treatment of Type 1 Diabetes or Diabetic Ketoacidosis (DKA).
Dosage & Administration
Recommended Dosage (Strictly as per Endocrinologist Guidelines):
- Standard Adult Dosing: 2.5 mg or 5 mg taken orally once daily.
- Administration: Can be taken with or without food. Tablets must be swallowed whole.
- Renal Impairment: In patients with an estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2, the dose must be strictly limited to 2.5 mg once daily.
- CYP3A4/5 Inhibitors: The dose must be limited to 2.5 mg once daily when co-administered with strong cytochrome P450 3A4/5 inhibitors (e.g., Ketoconazole, Clarithromycin, Ritonavir).
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Heart Failure Risk (SAVOR-TIMI 53 Trial): Clinical trials have shown that Saxagliptin specifically carries an increased risk of hospitalization for heart failure, particularly in patients with a prior history of heart failure or renal impairment. Healthcare providers must consider the risks and benefits before initiating therapy in these patients.
- Acute Pancreatitis: Post-marketing reports have identified cases of fatal and non-fatal acute pancreatitis associated with DPP-4 inhibitors. Patients must be counseled to seek immediate emergency care if they experience severe, persistent, radiating abdominal pain.
- Severe Joint Pain (Arthralgia): DPP-4 inhibitors can cause severe, sometimes disabling joint pain. Relief is typically observed rapidly upon discontinuation of the drug.
- Bullous Pemphigoid: Rare but serious cases of bullous pemphigoid (large, fluid-filled skin blisters) requiring hospitalization have been reported.
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 Endocrinological Formulations, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable Pharmacy Chain Supplier for diabetes 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.










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