Vildagliptin & Metformin Hydrochloride Tablets
Healthy Inc is a specialized global supplier and exporter of advanced endocrinology, metabolic, and modern glycemic control therapeutics. We provide high-purity, multi-kinetic Vildagliptin (50 mg) & Metformin Hydrochloride (500 mg / 850 mg / 1000 mg) Tablets, manufactured in WHO–GMP certified, high-capacity oral solid dosage facilities. This “Advanced Dual-Action Incretin Synergy” is a massive-volume, premium export to diabetic care centers, primary care networks, retail pharmacy distributors, and government health ministries in LATAM, the Middle East, Africa, and Southeast Asia, serving as the ultimate intervention for Type 2 Diabetes Mellitus that remains uncontrolled by Metformin monotherapy.
Product Overview
This highly advanced Fixed-Dose Combination (FDC) perfectly synchronizes two distinct, complementary mechanisms of action to achieve comprehensive, 24-hour blood glucose mastery without the weight gain associated with older diabetic drugs.
The “Incretin Enhancer & Hepatic Suppressor” Specialist:
- Mechanism 1 (Vildagliptin – The DPP-4 Inhibitor): Vildagliptin aggressively binds to and blocks the DPP-4 enzyme, preventing the breakdown of natural incretin hormones (GLP-1 and GIP) released after a meal. This massively amplifies the pancreas’s natural, glucose-dependent insulin secretion while simultaneously shutting down inappropriate glucagon release from the alpha cells. Because it only triggers insulin when blood sugar is actually high, the risk of hypoglycemia is virtually zero.
- Mechanism 2 (Metformin – The Insulin Sensitizer): Metformin (a Biguanide) works systemically to reduce fasting blood glucose by violently suppressing the liver’s natural production of glucose (gluconeogenesis). Concurrently, it increases the insulin sensitivity of peripheral muscle tissues, forcing the body to efficiently absorb and utilize the circulating glucose.
- The Synergistic Clinical Advantage: While Metformin handles the baseline fasting sugar, Vildagliptin specifically targets and flattens the dangerous post-meal spikes. Together, they provide profound reductions in HbA1c levels, offering a highly tolerable, weight-neutral therapy that actively preserves pancreatic beta-cell function over time.
Product Composition & Strength
We supply this product as a highly advanced Film-Coated Tablet (Available in Immediate or Bilayer Sustained-Release formats), packed strictly in high-barrier Alu-Alu blister strips. Alu-Alu packaging is completely non-negotiable, as Vildagliptin is intensely sensitive to moisture degradation.
| Active Ingredient | Strength & Format | Primary Clinical Use |
|---|---|---|
| Vildagliptin INN/Ph.Eur. | 50 mg (Immediate Release Layer) | Rapid dissolution to block DPP-4 and manage post-prandial incretin levels. |
| Metformin Hydrochloride USP/BP | 500 mg / 850 mg / 1000 mg (IR or SR) | Provides continuous baseline hepatic glucose suppression and peripheral sensitization. |
| Excipients | Hypromellose (HPMC) / Microcrystalline Cellulose / Titanium Dioxide | SR Polymer Matrix / Diluent / Film-Coating (Engineered for precise kinetic release) |
*Pack Sizes: 10×10 or 10×15 Alu-Alu Blisters (Optimized for 30-day chronic diabetic dispensing regimens).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Endocrinology Distributors, and Diabetic Clinics.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Antidiabetics) |
| CAS Numbers | 274901-16-5 (Vildagliptin) / 1115-70-4 (Metformin) |
| Dosage Form | Film-Coated Tablet (IR/IR or IR/SR Bilayer options available) |
| Packaging | High-Barrier Alu-Alu Blisters (CRITICAL). Vildagliptin is highly susceptible to hydrolytic degradation. Strict moisture barriers are mandatory to prevent API failure. |
| 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.
- Dehumidified Blending & High-Shear Engineering: Combining a highly moisture-sensitive molecule (Vildagliptin) with a massively bulky, poorly compressible molecule (Metformin) requires elite pharmaceutical engineering. Our facilities utilize dehumidified suites (RH < 40%) and advanced high-shear granulation to ensure perfect powder flow, absolute dose uniformity, and rock-solid tablet integrity without capping or friability.
- Bilayer Technology (For SR Variants): If the Sustained-Release (SR) Metformin profile is required, our high-tonnage rotary presses physically isolate the Vildagliptin into an immediate-release layer, while the Metformin is locked within an advanced hypromellose slow-release matrix, ensuring two flawless, independent pharmacokinetic profiles in a single pill.
Therapeutic Indications (Human Use)
Indicated for the comprehensive management of progressive metabolic disorders:
- Type 2 Diabetes Mellitus (T2DM): Indicated as an adjunct to diet and exercise to improve glycemic control in patients whose diabetes is inadequately controlled on Metformin hydrochloride alone, or in patients already treated with the combination of Vildagliptin and Metformin as separate tablets.
Dosage & Administration
Recommended Dosage (Strictly as per Endocrinologist/Physician):
- Administration (GASTRIC TOLERABILITY RULE): These tablets MUST be taken with or immediately after meals. Taking the medication on an empty stomach will result in the Metformin component causing severe gastrointestinal distress (nausea, vomiting, diarrhea).
- Standard Adult Dosing (Immediate Release): Typically one tablet (50mg/500mg or 50mg/850mg) taken twice daily, once in the morning and once in the evening.
- Swallowing Protocol: Especially for the SR variants, the tablet must be swallowed whole with a glass of water. It must never be crushed, chewed, or split.
Safety Warnings (CRITICAL):
- BLACK BOX WARNING (Lactic Acidosis): The Metformin component carries a rare but extremely fatal risk of lactic acidosis. This risk is massively elevated in patients with severe renal impairment, hepatic disease, or congestive heart failure. The drug must be temporarily discontinued prior to any intravascular radiocontrast imaging studies.
- Hepatic Monitoring (Vildagliptin Toxicity): Rare but severe cases of hepatic dysfunction have been reported. It is strictly required to perform Liver Function Tests (LFTs) before initiating therapy and to monitor them at three-month intervals during the first year of treatment.
- Acute Pancreatitis: All DPP-4 inhibitors carry a risk of inducing acute pancreatitis. Patients must be counseled on the hallmark symptom: severe, persistent, radiating abdominal pain. Discontinue immediately if suspected.
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 Endocrinology Formulations, allowing brands to launch high-quality generic medicines under their essential label. Whether you are looking for a reliable Hospital Tender Supplier for government diabetic 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.