Gliclazide + Metformin

Gliclazide + Metformin is a widely prescribed oral antidiabetic combination used in the management of Type 2 Diabetes Mellitus (T2DM). This fixed-dose combination (FDC) provides synergistic glucose-lowering effects by targeting both insulin secretion and insulin resistance, addressing the two core pathophysiological mechanisms of T2DM. As the prevalence of diabetes rises globally, demand for effective and affordable oral hypoglycemic agents continues to grow across both developing and developed markets.

BluepillExpress is a globally recognized third-party pharmaceutical manufacturer, offering contract manufacturing of Gliclazide + Metformin tablets in a wide range of strengths and modified-release formulations. With WHO-GMP certified infrastructure, modern technology, and robust regulatory capabilities, we offer compliant, scalable, and export-ready solutions for your diabetic product portfolio.

About the Combination: Gliclazide + Metformin

Gliclazide

• A second-generation sulfonylurea, Gliclazide stimulates pancreatic beta cells to release insulin.
• It also has antioxidant and antiplatelet properties, which can be advantageous in diabetic patients.
• Known for a low risk of hypoglycemia compared to other sulfonylureas.

Metformin

• A biguanide class drug, Metformin decreases hepatic glucose production, improves insulin sensitivity, and enhances peripheral glucose uptake.
• It is considered a first-line treatment for T2DM and improves lipid profiles in diabetic patients.

Together, the combination provides a dual mechanism:

• Gliclazide enhances insulin secretion, and
• Metformin reduces insulin resistance, making it ideal for comprehensive glycemic control.

Therapeutic Uses and Indications

Gliclazide + Metformin is primarily indicated for:

• Type 2 Diabetes Mellitus (T2DM) uncontrolled by diet and exercise alone
• As an adjunct to lifestyle interventions in newly diagnosed diabetics
• Patients inadequately controlled on Metformin monotherapy
• Step-up therapy to delay insulin initiation
• Long-term glycemic control to prevent diabetic complications
• Management of diabetic patients with cardiovascular risk factors

This combination is often used in once or twice daily regimens depending on formulation and dosage.

Why Choose BluepillExpress for Gliclazide + Metformin Manufacturing?

At BluepillExpress, we deliver complete third-party manufacturing solutions tailored to your needs—from product development to packaging and global regulatory support. We are your reliable partner for antidiabetic formulations backed by compliance, efficiency, and transparency.

Key Advantages:

• WHO-GMP and ISO 9001:2015 certified facility
• Compliance with IP/USP/EP/BP standards
• Immediate Release (IR) and Modified Release (MR) formulations
• Dedicated oral solid dosage manufacturing lines
• Dossier support for local and international markets
• Low Minimum Order Quantities (MOQs) for new brands
• Customized labeling and private branding options
• Strong quality control and pharmacovigilance support

Available Dosage Forms

We manufacture a broad range of Gliclazide + Metformin combinations, suitable for various patient populations, including elderly and obese individuals.

1. Immediate Release (IR) Formulations

• Gliclazide 80 mg + Metformin 500 mg IR
• Gliclazide 80 mg + Metformin 850 mg IR
• Dosage: Once or twice daily
• Packaging: Blister packs of 10×10 tablets or HDPE bottles
• Ideal for: Patients requiring flexible dose titration

2. Modified Release (MR) / Sustained Release (SR) Formulations

• Gliclazide 60 mg MR + Metformin 500 mg SR
• Gliclazide 60 mg MR + Metformin 1000 mg SR
• Dosage: Once daily
• Packaging: Alu-Alu blister or strip packs
• Ideal for: Better compliance and reduced GI side effects

These formulations are manufactured using controlled-release polymers and optimized granulation techniques to ensure consistent drug release over time.

Manufacturing Infrastructure

Our dedicated facility is equipped with advanced technology to ensure precise manufacturing of oral antidiabetic formulations, with focus on uniformity, bioavailability, and stability.

Facility Highlights:

• Automatic granulators and fluid bed dryers
• Compression machines with online weight control
• Auto-coaters for film coating of tablets
• Modified-release coating and compression technology
• Blister packing and bottle filling machines
• In-process and end-product testing laboratories
• Real-time ERP system for tracking and traceability
• ICH-compliant stability chambers for Zone II–IV

We ensure batch-to-batch consistency, robust process validation, and cleanroom controls to prevent cross-contamination.

Quality Assurance and Control

At BluepillExpress, Quality Assurance (QA) and Quality Control (QC) are embedded into every step of the manufacturing cycle.

QC Parameters:

• Assay of Gliclazide and Metformin
• Tablet weight, hardness, and friability
• Disintegration and dissolution profile
• Uniformity of content
• Stability studies (real-time and accelerated)
• Microbial testing
• Compatibility of excipients
• Visual inspection for film coat uniformity

All finished products are released only after passing internal quality benchmarks and regulatory specifications.

Documentation Provided:

• Certificate of Analysis (COA)
• Batch Manufacturing Record (BMR)
• Certificate of Pharmaceutical Product (CoPP)
• Stability Study Reports
• Product Specifications and MSDS
• Method of Analysis (MOA)

Regulatory Support

We provide complete regulatory assistance to our clients for successful product registration in India and across international markets.

Regulatory Services Include:

• CTD/ACTD dossier compilation
• WHO-GMP certificates
• Free Sale Certificates (FSC)
• Certificate of Origin (COO)
• Site Master File (SMF)
• Method validation and stability data
• Support for bioequivalence studies (on request)
• Regulatory labeling and artwork compliance

Our regulatory team has extensive experience registering antidiabetic products in Africa, CIS, Southeast Asia, and Latin America.

Private Label & Customization Services

BluepillExpress supports pharmaceutical marketing companies, distributors, and global startups by offering private label and white label manufacturing services for Gliclazide + Metformin.

Services Include:

• Branding and artwork development
• Country-specific label compliance
• Custom pack sizes and bulk packaging
• Quick product samples for evaluation
• Marketing material printing (optional)
• Brand confidentiality and NDA protection
• Flexible MOQs for new brand testing

We help you launch your product in record time without the cost of setting up a manufacturing unit.

Packaging Capabilities

We offer customized packaging that meets aesthetic, compliance, and logistical needs for both prescription (Rx) and hospital supply chains.

Primary Packaging:

• Alu-Alu blister packs (high-barrier protection)
• PVC blister packs
• HDPE bottles with desiccants for bulk supply
• Tamper-proof strip packaging

Secondary Packaging:

• Printed cartons with multilingual labeling
• Patient information leaflets
• QR-coded and serialized cartons (optional)
• Compliance with country-specific barcode norms

All packaging is validated for stability, traceability, and consumer safety.

Export and Global Supply Chain

BluepillExpress serves clients in over 35+ countries with a robust export logistics system that ensures reliable and timely product delivery.

Export Capabilities:

• Air and sea freight with temperature control (if needed)
• EXW, FOB, CIF, and DDP delivery models
• All documentation: COO, invoice, packing list, SDS
• Pre-shipment inspections (PSI) and third-party testing
• Support for government tenders and institutional supply
• Pharmacovigilance support and recall readiness systems

Our logistics and regulatory teams work together to ensure timely and hassle-free market access.

Minimum Order Quantities (MOQ)

We provide flexible MOQ plans to cater to a wide spectrum of businesses:

• Low MOQ: Suitable for startups, market testing, or samples
• Medium MOQ: For regional pharma distributors
• High-volume production: For tenders, hospitals, and large distributors

Our team works closely with your procurement and marketing departments to design a cost-effective supply model.

Testimonials

“BluepillExpress provided us with top-quality Gliclazide + Metformin tablets that exceeded our expectations. The regulatory support was exceptional.”
— Managing Director, East Africa

“We were able to launch our own brand of antidiabetic tablets thanks to BluepillExpress’ low MOQ and private label support.”
— Marketing Head, CIS Region

“Their modified-release formulations are stable and effective. Our doctors and patients have responded positively since the launch.”
— Product Manager, Southeast Asia

Conclusion

As diabetes becomes one of the most widespread chronic conditions globally, the need for high-quality, affordable, and reliable antidiabetic medicines is more urgent than ever. The Gliclazide + Metformin combination plays a pivotal role in glycemic control and remains a staple therapy across all levels of care.

At BluepillExpress, we combine pharmaceutical expertise, manufacturing excellence, and regulatory depth to offer comprehensive third-party solutions for Gliclazide + Metformin. Whether you’re launching a brand, entering a tender, or expanding your therapeutic offerings, we provide you with the tools, compliance, and quality to grow with confidence.