Description

Glimepiride, Pioglitazone & Metformin Hydrochloride SR Tablets

Healthy Inc is a global leader in the supply of high-complexity Fixed-Dose Combinations (FDC) for metabolic disorders. We provide premium Glimepiride, Pioglitazone & Metformin Hydrochloride Sustained Release (SR) Tablets, manufactured in WHO–GMP certified facilities. This triple-action therapy is a critical export for specialized endocrinology centers and National Diabetic Health Tenders in Southeast Asia, Africa, and LATAM.

Product Overview

This “Triple Power” formulation is designed for patients who require intensive glycemic control. It combines three anti-diabetic agents with distinct, non-overlapping mechanisms of action to achieve maximal HbA1c reduction.

The “Triple-Action” Metabolic Specialist:

• Glimepiride (The Secretagogue): A third-generation sulfonylurea that stimulates the pancreatic beta cells to increase insulin secretion. It has a rapid onset and is effective in controlling post-prandial glucose spikes.
• Pioglitazone (The Sensitizer): A thiazolidinedione (TZD) that acts as a potent PPAR-gamma agonist. It increases insulin sensitivity in the skeletal muscle and adipose tissue, addressing the core issue of insulin resistance at the cellular level.
• Metformin HCl SR (The Regulator): A biguanide in a Sustained Release (SR) matrix. It primarily suppresses hepatic glucose production (gluconeogenesis) and slows intestinal glucose absorption. The SR technology ensures 24-hour coverage and superior gastrointestinal tolerability.

Technical & Manufacturing Specifications

Advanced multi-layer tableting for controlled release and molecular stability.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from state-of-the-art metabolic units.

• Trilayer Tableting Technology: To prevent drug-drug interactions within the tablet and ensure specific release profiles, we utilize advanced multi-layer compression. This ensures the Glimepiride is released for immediate action, while the Metformin is slowly leached from its matrix.
• Low-Humidity Processing: Pioglitazone is sensitive to environmental degradation. Our manufacturing suites maintain RH < 30% to ensure chemical assay stability throughout the 24-month shelf life.
• Bioequivalence Validation: Every batch is tested against reference listed drugs (RLDs) to ensure that the three-way pharmacokinetic profile is maintained, preventing accidental hypoglycemic episodes.

Therapeutic Indications & Clinical Symptoms

• Type 2 Diabetes Mellitus: Management of hyperglycemia in patients where dual therapy (Metformin + Sulfonylurea or Metformin + TZD) has failed to achieve glycemic targets.
• Severe Insulin Resistance: Specifically beneficial for patients with metabolic syndrome and high abdominal adiposity.
• Glycemic Control: Significant reduction in Fasting Plasma Glucose (FPG), Post-Prandial Glucose (PPG), and HbA1c.

Dosage & Administration

• Administration: Typically once daily, taken with the first main meal (usually breakfast) to maximize insulin secretagogue efficiency.
• Warning: Contraindicated in patients with Type 1 Diabetes, severe renal impairment, or symptomatic heart failure (due to the Pioglitazone component).
• Monitoring: Regular liver function tests (LFT) and monitoring for peripheral edema are recommended.

Global Export & Contract Manufacturing Services

Healthy Inc is a verified Pharmaceutical Exporter in Mumbai, catering to Ministry of Health Tenders and private hospital chains. We offer Third Party Manufacturing for this Triple Combination with full CTD Dossier support for international registration. Our logistics expertise ensures secure, temperature-controlled transit to Vietnam, Philippines, Nigeria, and LATAM markets.

Commercial Inquiries

WhatsApp/Call: +91 7710003340
Email: info@healthyinc.co.in