Antidiabetic

Glimepiride + Metformin HydrochlorideThird Party Manufacturing in India

Looking to get Glimepiride + Metformin Hydrochloride manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
93479-97-1
Drug Class
Sulfonylurea + Biguanide combination
Molecular Formula
C₂₄H₃₄N₄O₅S·C₄H₁₂ClN₅
Molecular Weight
656.25 g/mol (combined)
Grade Standards
IP, USP, BP
Therapeutic Category
Antidiabetic
MOQ
Contact us for MOQ — varies by strength and dosage form
Dosage Forms
Tablet, Sustained Release Tablet

Mechanism of Action

Glimepiride + Metformin Hydrochloride combines the third-generation sulfonylurea glimepiride with the biguanide metformin, providing two complementary mechanisms of action that target the dual defects of type 2 diabetes.

Glimepiride works by binding to the sulfonylurea receptor on pancreatic beta cells, closing ATP-sensitive potassium channels, which depolarizes the cell membrane and opens voltage-dependent calcium channels. The resulting calcium influx triggers insulin exocytosis, increasing both basal and meal-stimulated insulin secretion. Glimepiride also has extrapancreatic effects — it enhances peripheral glucose uptake by promoting GLUT4 translocation in muscle and adipose tissue, an effect not seen with earlier sulfonylureas.

Metformin Hydrochloride acts primarily by suppressing hepatic glucose production through inhibition of gluconeogenesis and glycogenolysis. It also improves peripheral insulin sensitivity and reduces intestinal glucose absorption. These effects are mediated in part through activation of AMP-activated protein kinase, a master regulator of cellular energy homeostasis.

Together, glimepiride stimulates insulin secretion while metformin reduces insulin resistance and hepatic glucose output. This complementary mechanism allows the combination to achieve greater improvements in HbA1c than either agent alone, with lower doses of each component reducing the risk of dose-dependent side effects such as hypoglycemia and weight gain. The combination is typically used as a step-up therapy for patients who fail to achieve glycemic targets on metformin monotherapy.

Therapeutic Uses & Indications

Therapeutic Uses

Glimepiride + Metformin Hydrochloride is prescribed for:

  • Type 2 Diabetes Mellitus: This fixed-dose combination is indicated as a second-line therapy for adults with type 2 diabetes who have inadequate glycemic control on diet, exercise, and metformin monotherapy.
  • Step-Up Therapy: Used when HbA1c targets are not reached with single-agent therapy, providing a convenient single-tablet regimen that improves patient adherence.
  • Combination with Lifestyle Interventions: Prescribed alongside continued dietary modification and physical activity for comprehensive diabetes management.

Why Manufacturers Choose Glimepiride + Metformin

This fixed-dose combination is among the most widely prescribed antidiabetic products in India and emerging markets. The combination's appeal lies in its clinical rationale — it addresses both insulin secretion deficiency and insulin resistance, the two primary defects in type 2 diabetes. Glimepiride and metformin together offer a complementary safety profile, with glimepiride's risk of hypoglycemia partially offset by metformin's weight-neutral effect.

For Indian pharmaceutical manufacturers, this combination represents a high-volume opportunity across multiple channels including PCD franchise networks, institutional tenders, and export markets. The availability of multiple strengths — including SR formulations — allows manufacturers to differentiate their product range. Both APIs are well-established, readily available from domestic manufacturers, and supported by mature analytical methods, ensuring smooth quality control and regulatory compliance for WHO-GMP certified facilities.

This makes Glimepiride + Metformin Hydrochloride one of the most sought-after combinations for third party manufacturing in India, with consistent demand from PCD franchise operators and export-oriented companies.

Dosage Forms We Manufacture

Tablet
1mg+500mg · 1mg+1000mg · 2mg+500mg · 3mg+1000mg · 4mg+1000mg
Sustained Release Tablet
1mg+500mg SR · 1mg+1000mg SR · 2mg+500mg SR

Frequently Asked Questions

What is the minimum order quantity for Glimepiride + Metformin Hydrochloride?
Minimum order quantity for Glimepiride + Metformin Hydrochloride is Contact us for MOQ — varies by strength and dosage form. Please contact us for bulk pricing and custom quantities.
What dosage forms of Glimepiride + Metformin Hydrochloride can you manufacture?
We manufacture Glimepiride + Metformin Hydrochloride as: Tablet (1mg+500mg, 1mg+1000mg, 2mg+500mg, 3mg+1000mg, 4mg+1000mg); Sustained Release Tablet (1mg+500mg SR, 1mg+1000mg SR, 2mg+500mg SR).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Glimepiride + Metformin Hydrochloride for export?
Yes. We provide export-ready Glimepiride + Metformin Hydrochloride formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Glimepiride + Metformin Hydrochloride?
We manufacture Glimepiride + Metformin Hydrochloride to IP, USP, BP pharmacopoeial standards.
Third Party Manufacturing

Get Glimepiride + Metformin Hydrochloride made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • Low MOQ, export ready
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Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

Blister pack (Alu-Alu), Strip pack, HDPE bottle. Packaging customized to client brand guidelines.

Start Manufacturing Glimepiride + Metformin Hydrochloride Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Glimepiride + Metformin Hydrochloride across all dosage forms. PCD franchise and export orders welcome.

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