Glimepiride + Metformin

Glimepiride + Metformin is a widely prescribed oral antidiabetic combination therapy used for the management of Type 2 Diabetes Mellitus (T2DM). This dual-drug formulation combines the insulin-secreting effect of Glimepiride with the insulin-sensitizing and glucose-lowering capabilities of Metformin, offering synergistic control over blood sugar levels in patients who are unable to achieve glycemic control through monotherapy.

At BluepillExpress, we are committed to delivering high-quality, WHO-GMP-compliant, export-ready Glimepiride + Metformin formulations through scalable third-party manufacturing. With a reputation for pharmaceutical precision, regulatory compliance, and customer-centric services, we support clients around the world in launching or expanding their diabetic care product portfolios with confidence.

About BluepillExpress

BluepillExpress is a global pharmaceutical manufacturer and third-party service provider, operating in full compliance with WHO-GMP, ISO 9001:2015, and GLP standards. We serve pharmaceutical companies, healthcare institutions, public health organizations, and government procurement agencies across more than 25 countries, including regions in Asia, Africa, CIS, Latin America, and the Middle East.

Our comprehensive services include:

• End-to-end third-party and contract manufacturing
• Product formulation, customization, and development
• Regulatory documentation (CTD/ACTD dossiers)
• Private label and custom packaging solutions
• International logistics and export facilitation

We are focused on providing our clients with premium-quality pharmaceuticals tailored to their market needs and business models.

Product Overview: Glimepiride + Metformin Combination

Glimepiride + Metformin is an oral antidiabetic medication that works via a dual mechanism to lower blood glucose levels:

• Glimepiride: A sulfonylurea that stimulates insulin secretion from pancreatic β-cells.
• Metformin: A biguanide that reduces hepatic glucose production, improves insulin sensitivity, and enhances peripheral glucose uptake.

This fixed-dose combination is ideal for patients with Type 2 Diabetes who require complementary therapeutic actions to manage fasting and postprandial blood sugar levels.

Mechanism of Action

Glimepiride acts by:

• Stimulating insulin release through ATP-sensitive potassium channels in pancreatic beta cells.
• Enhancing insulin sensitivity at peripheral tissues.

Metformin acts by:

• Inhibiting hepatic gluconeogenesis (glucose production in the liver).
• Improving peripheral glucose uptake and utilization.
• Reducing gastrointestinal glucose absorption.

Together, the combination delivers a synergistic glucose-lowering effect with a lower risk of hypoglycemia compared to high-dose sulfonylurea monotherapy.

Therapeutic Indications

• Type 2 Diabetes Mellitus (T2DM) inadequately controlled by diet, exercise, or monotherapy
• As part of a comprehensive diabetes management regimen
• In patients requiring dual oral therapy to achieve glycemic targets
• Can be used alongside insulin therapy when indicated

Available Dosage Forms and Strengths

BluepillExpress manufactures Glimepiride + Metformin in a variety of fixed-dose strengths, ensuring flexible titration and therapeutic efficacy. All formulations comply with IP, USP, BP, and Ph. Eur. specifications.

Formulation Options:

1. Immediate Release (IR) Tablets
   • Glimepiride 1 mg + Metformin 500 mg
   • Glimepiride 2 mg + Metformin 500 mg
   • Glimepiride 2 mg + Metformin 850 mg
   • Glimepiride 2 mg + Metformin 1000 mg
2. Sustained Release (SR) / Extended Release (XR) Tablets
   • Glimepiride 2 mg + Metformin 500 mg SR
   • Glimepiride 2 mg + Metformin 1000 mg SR
3. Bilayer Tablets(on request)
   • One layer for immediate release Glimepiride
   • One layer for sustained release Metformin
   • Ideal for once-daily dosing with optimal pharmacokinetics

Tablet Characteristics:

• Film-coated for easier swallowing
• Stable under varied climatic conditions
• Blister-packed or bottle-packed as per client requirements

Manufacturing Infrastructure

Our modern manufacturing plants are designed for high-capacity, high-precision tablet production, equipped with automated systems and segregated zones for antihyperglycemic agents.

Key Infrastructure Highlights:

• Automatic granulation, blending, and compression units
• Tablet coating systems (auto-coater with air exhaust)
• SR/XR matrix tablet compression and bilayer technology
• Dehumidified processing zones
• Quality assurance laboratories with HPLC and UV analysis
• Validated HVAC and purified water systems

Our facilities follow stringent SOPs and Good Manufacturing Practices (GMP) to ensure batch-to-batch uniformity and product integrity.

Quality Assurance and Control

Quality is our cornerstone at BluepillExpress. Our Quality Management System (QMS) integrates control at every stage of the manufacturing process — from raw material procurement to finished product dispatch.

Quality Assurance Processes Include:

• Vendor validation and raw material quality testing
• In-process control (hardness, friability, weight variation, dissolution)
• Finished product testing for:
  • API assay and content uniformity
  • Disintegration and dissolution profiles
  • Microbial load
  • Impurity profiling
• Stability testing under ICH Zone II & IVB conditions
• Batch-wise release with Certificate of Analysis (CoA)

Our laboratories are equipped with HPLC, UV-VIS spectrophotometers, FTIR, pH meters, friability testers, and humidity chambers to ensure precise and reliable analysis.

Packaging Options

We offer flexible and client-specific packaging solutions that meet international labeling and safety requirements. Custom private labeling is available to match your brand identity.

Packaging Formats:

• Blister packs (PVC/Alu or Alu-Alu)
• Strip packs for cost-effective markets
• HDPE bottles with desiccant for institutional supply
• Mono cartons with multilingual printed inserts
• Export cartons with tamper-evident seals and barcoding

All packaging materials undergo stability and compatibility testing and are sourced from certified vendors to ensure product shelf-life and presentation.

Regulatory and Documentation Support

BluepillExpress provides comprehensive documentation support to help clients navigate regulatory approvals and ensure product registration in international markets.

We provide:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (CoPP)
• Certificate of Analysis (CoA)
• Free Sale Certificate
• Batch Manufacturing Records (BMR)
• Common Technical Document (CTD/ACTD format)
• Product Dossier for registration
• Stability study reports (accelerated & real-time)
• Material Safety Data Sheet (MSDS)

We also assist in compiling dossiers compliant with NAFDAC, PPB, FDA, TGA, ANVISA, EMA, and GCC-DR regulations.

Global Export and Logistics

Our robust international logistics framework ensures timely and hassle-free product delivery to clients worldwide. Whether for commercial distribution, institutional supply, or government tenders, we handle every step of the export process professionally.

Logistics Services Include:

• Air and sea freight arrangements
• Export documentation and customs clearance
• Cold chain (if required) and controlled shipping
• Labeling customization per destination country
• Support for import permits, registration, and certification

We currently export to:

• Africa: Kenya, Nigeria, Ghana, Ethiopia, South Africa
• Asia: Vietnam, Myanmar, Sri Lanka, Bangladesh
• CIS: Uzbekistan, Georgia, Tajikistan
• Latin America: Peru, Bolivia, Guatemala
• Middle East: UAE, Iraq, Jordan, Yemen

Target Clients for Third-Party Manufacturing

Our Glimepiride + Metformin manufacturing services are ideally suited for:

• Generic pharmaceutical companies
• Hospitals and diabetes care centers
• Government health departments and NGOs
• Online pharmacies and digital health brands
• Multinational companies expanding into emerging markets
• Private label marketers and brand owners

We support low minimum order quantities (MOQs) for startups and offer bulk production options for institutional contracts and tenders.

Why Choose BluepillExpress?

1. WHO-GMP Certified Infrastructure
   High-quality pharmaceutical manufacturing with international compliance.
2. Complete Regulatory & Dossier Support
   CTD, CoPP, and stability documents tailored to your target market.
3. Flexible Manufacturing & Packaging
   IR, SR, bilayer tablets and multiple packaging solutions.
4. High Production Capacity & Fast Turnaround
   Timely delivery even for high-volume orders.
5. Global Export Capability
   Trusted by distributors in 25+ countries with seamless logistics.
6. Private Label and Custom Branding
   Launch your brand with complete identity support.
7. Strict Quality Control and Batch Consistency
   Assured therapeutic efficacy and compliance with pharmacopeial standards.

Conclusion

Glimepiride + Metformin is a vital medication in modern diabetes management, offering patients a safe, effective, and affordable dual-action treatment option. With diabetes prevalence on the rise globally, the demand for reliable fixed-dose combinations continues to grow.

Partnering with BluepillExpress means gaining access to a robust pharmaceutical manufacturing ecosystem — one that delivers quality, reliability, and regulatory support at every step. Whether you’re entering a new market or enhancing your product range, we are your strategic ally in diabetic care formulations.