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Metformin with Glimepiride Tablets - reference product image

Glimepiride & Metformin HCl SR Tablets

Product: Glimepiride & Metformin Hydrochloride SR Tablets

Reference strengths: 1 mg/500 mg, 2 mg/500 mg, 1 mg/1000 mg — composition confirmation pending.

Other supplied formulations: Glimepiride IP/BP 1 mg, 2 mg, 4 mg; SMEGLIP-1; SMEGLIP-2; Glimepiride 2 mg + Pioglitazone 15 mg + Metformin HCl 500 mg SR (separate triple combination).

Usage: Management of type 2 diabetes under medical supervision.

Category: Anti Diabetic Drugs

Therapeutic Category: Antidiabetic

SKU: Glimepiride & Metformin HCl SR Tablets

Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations

Product Information

Glimepiride & Metformin HCl SR Tablets is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Glimepiride and Metformin HCl SR Tablets

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. manufactures antidiabetic tablets in India. Glimepiride is a sulfonylurea that promotes pancreatic insulin secretion; metformin reduces hepatic glucose production and improves insulin sensitivity. Fixed-dose combinations may be prescribed for selected adults with type 2 diabetes when clinically appropriate.

Composition verification: The supplied product list contains glimepiride-only tablets and one glimepiride/pioglitazone/metformin SR triple combination. It does not provide a verified two-ingredient glimepiride + metformin SR composition. The 1 mg/500 mg, 2 mg/500 mg and 1 mg/1000 mg pairs in the descriptive heading are therefore pending confirmation.

2. Product Specifications

VariantCompositionFormType
Glimepiride Tablets IP 1 mgGlimepiride IP 1 mgFilm-coated tabletSingle ingredient
Glimepiride Tablets IP 2 mgGlimepiride IP 2 mgFilm-coated tabletSingle ingredient
Glimepiride Tablets BP 1 mgGlimepiride BP 1 mgFilm-coated tabletSingle ingredient
Glimepiride Tablets BP 2 mgGlimepiride BP 2 mgFilm-coated tabletSingle ingredient
Glimepiride Tablets BP 4 mgGlimepiride BP 4 mgFilm-coated tabletSingle ingredient
SMEGLIP-1Glimepiride BP 1 mg; excipients q.s.Film-coated tabletSingle ingredient
SMEGLIP-2Glimepiride BP 2 mg; excipients q.s.Film-coated tabletSingle ingredient
Glimepiride + Pioglitazone + Metformin HCl SRGlimepiride 2 mg + Pioglitazone 15 mg + Metformin HCl 500 mg; excipients q.s.Sustained-release tabletThree-drug combination

Reference ingredients: Glimepiride CAS 93479-97-1; Metformin hydrochloride CAS 1115-70-4. Specific shelf life, packaging and release specifications depend on the approved product dossier.

3. Manufacturing Technology

Combination formulations require appropriate controls for low-dose glimepiride content uniformity and metformin modified-release performance. Bilayer or polymer-matrix designs are possible formulation approaches, but the manufacturing method for this specific product must be confirmed against its master formula. Modified-release tablets require validated release profiles and suitable moisture-protective packaging.

4. Quality Assurance

Quality evaluation may include identity, assay, dosage uniformity, impurities, and dissolution testing at appropriate time points for modified-release components. Exact limits and testing schedules are those of the approved pharmacopoeial or registered specification; bioequivalence should not be claimed without evidence.

5. Pharmacology and Clinical Use

Glimepiride closes ATP-sensitive potassium channels in pancreatic beta cells, increasing insulin release and potentially causing hypoglycaemia. Its action is not glucose-dependent. Metformin acts primarily by reducing hepatic glucose output and improving insulin sensitivity. Pioglitazone, in the separately listed triple combination, increases insulin sensitivity but carries additional risks including fluid retention.

6. Export and Regulatory Support

Product-specific certificates of analysis, regulatory dossiers and export documents may be supplied subject to availability and destination-market requirements. Product registration, manufacturing claims and certificates should be verified for the exact strength and formulation.

7. Frequently Asked Questions

Who manufactures these tablets?
Healthy Life Pharma Pvt. Ltd., India.

Is the 1 mg/500 mg combination confirmed?
Not from the supplied composition list; confirmation is required before publication as an available SKU.

Can glimepiride cause low blood sugar?
Yes. Risk increases with missed meals, illness, alcohol use or other glucose-lowering drugs.

Can SR tablets be crushed?
Do not crush or chew modified-release tablets unless the approved product label explicitly permits it.

8. Dosage and Administration

Dosage and titration depend on the exact formulation, kidney function, glucose measurements and other therapies. Take only as prescribed, usually with meals as directed by the registered label. Glimepiride-only and combination products are not interchangeable; follow specific instructions for modified-release tablets.

9. Side Effects and Precautions

  • Hypoglycaemia: Glimepiride may cause sweating, shaking, confusion or severe low blood sugar.
  • Metformin: Gastrointestinal symptoms and a rare risk of lactic acidosis, especially with significant renal impairment or acute illness; kidney function assessment is important.
  • Pioglitazone: The separately listed triple combination may cause oedema or worsen heart failure and requires individualized assessment.
  • Interactions: Alcohol and other medicines can affect glucose control; review the full medication list with a clinician.

10. Storage Instructions

Store according to the approved pack label, protected from excess moisture and heat. Keep medicines out of reach of children.