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Reference image for Metformin with Glimepiride tablets

Glimepiride, Pioglitazone & Metformin HCl SR Tablets

Composition per SR tablet: Glimepiride 2 mg + Pioglitazone 15 mg + Metformin Hydrochloride 500 mg; excipients q.s.

Usage: Management of type 2 diabetes in appropriately selected patients.

Category: Anti Diabetic Drugs

Therapeutic Category: Antidiabetic

SKU: Glimepiride-Pioglitazone-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, Pioglitazone & 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, Pioglitazone 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. presents a triple fixed-dose combination of glimepiride 2 mg, pioglitazone 15 mg and metformin hydrochloride 500 mg in a sustained-release tablet for selected patients with type 2 diabetes under medical supervision. The three medicines address insulin secretion, insulin sensitivity and hepatic glucose production through complementary mechanisms.

Third-party manufacturing and export enquiries may be directed to Healthy Life Pharma Pvt. Ltd. and Healthy Inc. Exact manufacturing and registration details must be confirmed for each destination market.

2. Product Specifications

Product / VariantComposition per tabletDosage formStatus
Triple fixed-dose combinationGlimepiride 2 mg + Pioglitazone 15 mg + Metformin Hydrochloride 500 mg; excipients q.s.Sustained-release tabletConfirmed composition
Glimepiride IP 1 mgGlimepiride IP 1 mgFilm-coated tabletSeparate single-ingredient product
Glimepiride IP 2 mgGlimepiride IP 2 mgFilm-coated tabletSeparate single-ingredient product
Glimepiride BP 1 mgGlimepiride BP 1 mgFilm-coated tabletSeparate single-ingredient product
Glimepiride BP 2 mgGlimepiride BP 2 mgFilm-coated tabletSeparate single-ingredient product
Glimepiride BP 4 mgGlimepiride BP 4 mgFilm-coated tabletSeparate single-ingredient product
SMEGLIP-1Glimepiride BP 1 mg; excipients q.s.Film-coated tabletSeparate single-ingredient brand
SMEGLIP-2Glimepiride BP 2 mg; excipients q.s.Film-coated tabletSeparate single-ingredient brand

Therapeutic class: Antidiabetic, triple fixed-dose combination. CAS: Glimepiride 93479-97-1; pioglitazone 111025-46-8; metformin hydrochloride 1115-70-4. Packaging, shelf life, appearance and pharmacopoeial compliance: subject to approved specifications.

Note: The proposed glimepiride 1 mg + pioglitazone 15 mg + metformin 500 mg SR strength is not confirmed by the supplied composition. The glimepiride-only tablets listed above are distinct products, not triple combinations.

3. Manufacturing Technology

Triple-combination modified-release tablets require precise blending and content uniformity for low-dose glimepiride, compatibility evaluation for the three active ingredients, and validated metformin release characteristics. Multilayer compression or a polymer-matrix system may be used when supported by the actual formulation dossier; a specific process or 24-hour release duration is not assumed here.

Appropriate packaging is selected on the basis of stability studies and the approved market specification.

4. Quality Assurance

Product-specific quality controls can include identification, assay, related substances, dosage-unit uniformity, stability and dissolution testing for each active ingredient, including multiple sampling points for the modified-release component. Release limits, humidity controls and acceptance criteria must follow the validated specification rather than generic values.

5. Pharmacology and Clinical Use

Glimepiride: stimulates insulin secretion from pancreatic beta cells and may cause significant hypoglycaemia. Pioglitazone: activates PPAR-gamma to improve insulin sensitivity but can cause fluid retention and worsen heart failure. Metformin: reduces hepatic glucose production and improves insulin sensitivity.

This formulation may be considered for selected adults with type 2 diabetes when its ingredients and doses are appropriate. It is not a universal choice for all patients who have inadequate glucose control on two medicines.

6. Export and Regulatory Support

Enquire about the availability of a certificate of analysis, approved product specifications, registration dossiers (CTD/ACTD where applicable), manufacturing certificates and shipping documentation. Regulatory status and document availability must be verified for the exact formulation and destination country.

7. Frequently Asked Questions

Q: What is the confirmed triple-combination strength?
A: Glimepiride 2 mg + pioglitazone 15 mg + metformin hydrochloride 500 mg SR, as provided in the composition.

Q: Are SMEGLIP-1 and SMEGLIP-2 the same triple combination?
A: No. The supplied SMEGLIP formulations contain glimepiride only.

Q: Can pioglitazone cause fluid retention?
A: Yes. New swelling, rapid weight gain or shortness of breath require prompt medical evaluation, particularly where heart failure is a concern.

Q: Can an SR tablet be crushed?
A: Modified-release tablets should generally be swallowed whole unless the approved label specifically allows another method.

8. Dosage and Administration

The prescriber determines whether this combination and strength are suitable based on current therapy, blood glucose, kidney and liver function, and risk factors. Follow the approved label for timing with meals. Do not independently adjust doses or skip medication without medical advice. Do not crush or chew the sustained-release tablet unless explicitly permitted by its approved labeling.

9. Side Effects and Precautions

  • Hypoglycaemia: Glimepiride can cause low blood sugar, particularly with missed meals, illness or interacting medicines.
  • Heart failure and oedema: Pioglitazone may cause or worsen fluid retention and heart failure. It should not be used in certain patients with symptomatic heart failure; assess the applicable label contraindications.
  • Bladder cancer: Pioglitazone warrants caution or avoidance in patients with active bladder cancer, according to local prescribing information.
  • Metformin-associated lactic acidosis: Rare but serious; assess renal function and withhold in circumstances specified by the approved label.
  • Other concerns: Weight gain, fractures, gastrointestinal upset, liver disease and medicine interactions require clinical review.

10. Storage Instructions

Store in the original packaging in a cool, dry place and follow the temperature and moisture precautions on the approved product label. Keep out of reach of children.