Description
Nateglinide Film-Coated Tablets (60 mg / 120 mg)
Healthy Inc is a specialized global supplier and exporter of advanced endocrinology, metabolic, and anti-diabetic therapeutics. We provide ultra-high-purity, kinetically precise Nateglinide Film-Coated Tablets (60 mg / 120 mg), manufactured in WHO–GMP certified, high-precision rapid-dissolution oral solid dosage facilities. This “Rapid-Acting Meal-Time Insulin Secretagogue” is a highly lucrative, premium export to diabetic care centers, endocrinology clinics, retail pharmacy networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, high-compliance intervention for the targeted control of postprandial (after-meal) hyperglycemia in Type 2 Diabetes Mellitus.
Product Overview
This highly advanced formulation utilizes a highly targeted D-phenylalanine derivative to fundamentally mimic the body’s natural, immediate insulin response to eating, preventing the massive sugar spikes that silently destroy a diabetic patient’s eyes, kidneys, and blood vessels.
The “Postprandial Spike & Rapid-Onset” Specialist:
- Mechanism 1 (The Beta-Cell Trigger): When a Type 2 Diabetic patient eats a meal, their pancreas is too slow to release insulin, causing a massive surge of toxic sugar into the blood. Nateglinide aggressively binds to the sulfonylurea receptor 1 (SUR1) on the pancreatic beta cells. This closes ATP-dependent potassium channels, causing the cell membrane to depolarize. This opens calcium channels, and the sudden influx of calcium violently forces the pancreas to immediately release its stored insulin, directly intercepting the meal-time sugar spike.
- Mechanism 2 (The “Hit and Run” Safety Advantage): Older diabetic drugs (like Glyburide or Glimepiride) bind to these same receptors but stay attached for up to 24 hours, meaning the pancreas pumps insulin even when the patient isn’t eating, risking fatal hypoglycemia. Nateglinide is engineered for a “hit and run” effect. It acts within 20 minutes of swallowing, peaks during digestion, and is rapidly cleared from the body in under 4 hours, drastically lowering the risk of life-threatening fasting hypoglycemia.
- The Erratic Lifestyle Protector: Because of its rapid-on/rapid-off profile, Nateglinide is the gold standard for diabetic patients who have erratic, unpredictable eating schedules (like shift workers). If they eat, they take a pill; if they skip a meal, they skip the pill, providing unmatched lifestyle flexibility.
Product Composition & Strength
We supply this product as a Precision-Blended, Rapid-Disintegrating Film-Coated Tablet, packed exclusively in highly secure, moisture-resistant Alu-Alu or high-density PVC/PVDC blister strips to ensure the absolute chemical stability of the highly soluble API.
| Active Ingredient | Strength | Primary Clinical Function |
|---|---|---|
| Nateglinide Ph.Eur./USP | 60 mg | Initiation / Mild Standard: Base therapeutic unit for patients nearing their HbA1c goal who only require mild postprandial glycemic control. |
| Nateglinide Ph.Eur./USP | 120 mg | Global Clinical Standard: Primary adult maintenance dose for severe meal-time spikes, taken immediately before the three main meals of the day. |
| Excipients | Microcrystalline Cellulose / Croscarmellose Sodium / Povidone K30 / Colloidal Silicon Dioxide / Magnesium Stearate / Premium Opadry Film | Diluent / Superdisintegrant / Binder / Glidant (Engineered specifically to shatter and dissolve in the stomach in under 15 minutes, guaranteeing the insulin surge perfectly matches the digestion of the meal) |
*Pack Sizes: 3×10 or 10×10 Blisters (Optimized specifically for high-turnover diabetic dispensing, as patients consume 3 tablets per day).
Technical & Logistics Specifications
Critical data for Pharmaceutical Importers, Endocrinology Distributors, and Hospital Procurement Boards.
| HS Code | 3004.90.99 (Medicaments containing other active substances – Endocrinology/Anti-Diabetics) |
| CAS Number | 105816-04-4 (Nateglinide) |
| Dosage Form | Film-Coated Tablet (Rapid Immediate Release) |
| Packaging | High-Density PVC/PVDC or Alu-Alu Blisters. Protects the rapid-disintegrating formulation from environmental humidity across Zone IVb tropical climates. |
| Storage | Store strictly below 30°C in a dry place. Protect from Moisture. |
Manufacturing Authority
Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.
- Rapid-Disintegration Super-Disintegrant Engineering: The entire clinical value of Nateglinide relies on extreme speed. If the tablet dissolves slowly, the insulin will be released *after* the sugar has already spiked, causing delayed hypoglycemia. Our facilities utilize advanced high-shear wet granulation infused with elite superdisintegrants (like Croscarmellose Sodium). This guarantees that the tablet undergoes a violent, immediate structural collapse the moment it hits gastric fluid, ensuring perfect pharmacokinetic synchronization with the patient’s meal.
Therapeutic Indications (Human Use)
Indicated for the highly targeted management of metabolic dysfunction:
- Type 2 Diabetes Mellitus: As monotherapy to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise alone, specifically targeting postprandial glucose elevations.
- Combination Therapy: Frequently used in combination with Metformin or Thiazolidinediones (like Pioglitazone) to provide comprehensive fasting and meal-time glycemic control.
- Note: Strictly contraindicated in Type 1 Diabetes and Diabetic Ketoacidosis (as it requires functioning pancreatic beta cells to work).
Dosage & Administration
Recommended Dosage (Strictly as per Endocrinologist Guidelines):
- Standard Adult Dosing: 120 mg taken three times daily.
- Administration (THE 30-MINUTE MEAL RULE – CRITICAL): Tablets MUST be taken 1 to 30 minutes before a meal.
- The “Skip Meal, Skip Dose” Rule: Because it forces immediate insulin release, if a patient skips a meal, they MUST skip the corresponding dose of Nateglinide. If they take the pill without eating, they will suffer a massive, potentially fatal hypoglycemic crash.
Safety Warnings (CRITICAL Regulatory & Clinical Data):
- Severe Hypoglycemia: While safer than sulfonylureas, all insulin secretagogues can cause severe hypoglycemia (low blood sugar), characterized by tremors, sweating, extreme confusion, and coma. This risk is massively amplified by severe exercise, alcohol ingestion, or severe renal/hepatic impairment.
- CYP2C9 & CYP3A4 Drug Interactions: Nateglinide is heavily metabolized by liver enzymes. Co-administration with strong CYP2C9 inhibitors (like Fluconazole or Amiodarone) will massively spike Nateglinide blood levels, leading to dangerous hypoglycemia. Conversely, enzyme inducers (like Rifampin) will completely destroy its clinical efficacy.
- Weight Gain: Because it increases systemic insulin (a growth hormone that stores fat), patients frequently experience mild to moderate weight gain during therapy.
Global Export & Contract Manufacturing Services
Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving international Pharma Traders, Wholesalers, and Endocrinology Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Metabolic and Rapid-Release 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.








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