Composition: Metformin Hydrochloride 500 mg + Glimepiride 1 mg
Dosage form: Sustained-release tablet
Usage: Management of type 2 diabetes mellitus
Category: Anti Diabetic Drugs
Therapeutic category: Antidiabetic (Biguanide + Sulfonylurea)
SKU: Metformin and Glimepiride SR Tablets
Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations
Metformin Hydrochloride & Glimepiride 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.
Manufacturer: Healthy Life Pharma Pvt. Ltd. (WHO-GMP certification to be verified)
Exporter: Healthy Inc (Star Export House status to be verified)
Metformin Hydrochloride & Glimepiride SR Tablets combine two oral glucose-lowering agents for management of type 2 diabetes mellitus when a clinician considers combination therapy appropriate. Metformin primarily reduces hepatic glucose production and improves insulin sensitivity; glimepiride increases insulin release from functioning pancreatic beta cells.
The supplied composition confirms a sustained-release tablet containing Metformin Hydrochloride 500 mg + Glimepiride 1 mg. Healthy Life Pharma Pvt. Ltd. is identified as manufacturer and Healthy Inc as exporter in the supplied product information. Manufacturing site, certifications and export claims require documentary verification.
| Product name | Metformin Hydrochloride & Glimepiride SR Tablets |
|---|---|
| Confirmed combination strength | Metformin Hydrochloride 500 mg + Glimepiride 1 mg |
| Release type | Sustained-release tablet; release characteristics require approved product specifications |
| Therapeutic class | Biguanide + sulfonylurea; oral antidiabetic |
| Indication | Type 2 diabetes mellitus when combination therapy is clinically appropriate |
| Other metformin-only products | Metformin HCl IP 500 mg; IP 1 g; BP 500 mg; BP 850 mg; Trippleace Metformin-500 BP 500 mg |
| Other combination strengths | 500/2, 500/3, 1000/1–4 mg mentioned in marketing text but not confirmed by supplied composition |
| Shelf life / packaging | To be confirmed from approved product and stability documents |
Separate metformin-only formulations: Metformin IP 500 mg and 1 g, Metformin BP 500 mg and 850 mg, and Trippleace Metformin-500 BP 500 mg are not the same as the fixed-dose combination. Their compositions must not be mixed in a single product label.
Sustained-release metformin formulations require validated release-control technology and robust content uniformity for low-dose glimepiride. Matrix-based or bilayer manufacturing may be used depending on the approved formulation, but bilayer construction, specific polymers, immediate-release glimepiride kinetics and a 24-hour release profile are not established by the supplied composition.
Manufacturing process, dissolution method, moisture controls and packaging must be supported by the actual batch records and stability program.
Quality evaluation should cover identity, assay, uniformity of dosage units, dissolution/release profile, related substances and stability in accordance with the applicable approved pharmacopoeial monograph and registered specifications. No universal dissolution percentages or assay limits should be asserted without product-specific methods and acceptance criteria.
Any certification, batch-release testing or impurity-screening claims should be supported by current documentation.
Metformin: lowers liver glucose production and improves insulin sensitivity. Glimepiride: stimulates insulin secretion and can cause hypoglycemia, especially with missed meals or reduced calorie intake.
This combination may be used for adults with type 2 diabetes who need both agents, subject to clinical assessment and local approval. It is not for type 1 diabetes or diabetic ketoacidosis. Dose and suitability depend on renal function, glucose readings, HbA1c, other medicines and hypoglycemia risk.
Product registration may require CTD/ACTD dossiers, validated manufacturing and analytical documentation, certificates of analysis, stability data and market-specific labeling. Availability of COPP, free-sale certificates, WHO-GMP documentation, and export permissions must be confirmed before being promised. Shipping terms and destinations are subject to applicable import/export rules.
Q: What is the confirmed combination?
A: Metformin Hydrochloride 500 mg + Glimepiride 1 mg in a sustained-release tablet.
Q: Are 500 mg and 850 mg metformin tablets the same product?
A: No. Metformin-only tablets are separate products and do not contain glimepiride.
Q: Can I crush or split an SR tablet?
A: Do not crush or chew it. Splitting should be considered only if expressly permitted by the approved product label.
Q: Can it cause low blood sugar?
A: Yes. Glimepiride can cause hypoglycemia, particularly when meals are skipped.
Take only as prescribed. The appropriate strength, frequency and titration depend on the registered formulation and individual patient factors. Many extended-release metformin regimens are taken with a meal, but the exact timing of this combination must follow its approved label. Swallow sustained-release tablets whole unless the approved labeling explicitly states otherwise. Do not change dose or skip meals without medical guidance.
Hypoglycemia: glimepiride can cause sweating, shakiness, confusion and, rarely, severe low blood sugar. Gastrointestinal effects: metformin can cause nausea, abdominal discomfort and diarrhea. Lactic acidosis: rare but potentially life-threatening; risk increases with significant renal impairment, hypoxia, severe illness and certain other conditions.
Renal function should be assessed before and during metformin therapy; restrictions vary by approved label and eGFR. Metformin may need to be temporarily withheld around certain iodinated contrast procedures or acute illnesses. Long-term use may lower vitamin B12. Review interactions, pregnancy/breastfeeding considerations, alcohol intake and sulfonylurea-related hypoglycemia with a clinician.
Store in the original container or blister, protected from moisture and excessive heat, according to the approved label. A specific below-25°C claim and shelf life must be verified against the registered stability data. Keep out of reach of children.