Glibenclamide

The global prevalence of type 2 diabetes mellitus continues to rise, making the availability of effective oral hypoglycemic agents a critical component in chronic disease management. Among the most widely prescribed medications in this category is Glibenclamide (also known as Glyburide), a second-generation sulfonylurea that plays a key role in glycemic control by stimulating pancreatic insulin secretion.

At BluepillExpress, we are proud to offer third-party manufacturing services for Glibenclamide, ensuring consistent quality, therapeutic efficacy, and cost-effectiveness. Our WHO-GMP certified facilities and international regulatory experience allow us to serve a diverse clientele, including pharmaceutical companies, health ministries, NGOs, and institutional buyers across the globe.

About BluepillExpress

BluepillExpress is an India-based global pharmaceutical manufacturer and third-party manufacturing partner. With a strong portfolio of antidiabetics, cardiovascular drugs, antibiotics, antifungals, and nutraceuticals, we cater to clients in Africa, Asia, Latin America, CIS, and the Middle East.

Our Key Strengths:

• WHO-GMP & ISO 9001:2015 certified manufacturing plants
• Comprehensive regulatory support (CTD/ACTD dossiers, COPP, CoA)
• Flexible manufacturing volumes and packaging options
• Private labeling and brand development
• Rapid turnaround and consistent batch production
• Export compliance with over 30 countries worldwide

BluepillExpress blends innovation, affordability, and precision in all manufacturing projects to meet international quality expectations.

Product Overview: Glibenclamide

Glibenclamide is an oral sulfonylurea-class hypoglycemic agent that lowers blood sugar levels by increasing the release of insulin from pancreatic beta cells. It is commonly prescribed as a monotherapy or in combination with other antidiabetics for the management of type 2 diabetes mellitus.

Pharmacological Class: Second-generation sulfonylurea
Mechanism of Action: Stimulates insulin release by blocking ATP-sensitive potassium channels in pancreatic beta cells
Onset of Action: Within 1 hour
Duration of Action: Up to 24 hours (dose-dependent)

Therapeutic Indications

Glibenclamide is indicated for:

• Type 2 diabetes mellitus (non-insulin dependent)
• Hyperglycemia unresponsive to dietary modification alone
• Combination therapy with metformin or insulin (under supervision)
• Used in public health programs for chronic disease management

Due to its long duration of action and proven glycemic control, Glibenclamide remains a cost-effective and widely used antidiabetic drug in developing and emerging markets.

Available Dosage Forms and Strengths

At BluepillExpress, we manufacture Glibenclamide in multiple dosage forms and strengths tailored to patient and prescriber needs:

• Glibenclamide 2.5 mg Tablets
• Glibenclamide 5 mg Tablets
• Combination Tablets: Glibenclamide + Metformin (available on request)
• Modified-release tablets or dispersible forms available for special markets

All formulations are compliant with IP, BP, or USP standards, depending on destination market requirements.

Advantages of Glibenclamide

• Potent glucose-lowering effect with once or twice-daily dosing
• Cost-effective treatment for low-resource healthcare settings
• High patient adherence due to long duration of action
• Easily combinable with other oral antidiabetics
• Effective as part of national diabetes control programs
• Suitable for adult patients not controlled by diet and exercise alone

Manufacturing Infrastructure at BluepillExpress

BluepillExpress operates advanced manufacturing lines equipped for mass production of oral solid dosage forms such as tablets and capsules. Our facilities support scalable production of Glibenclamide with robust quality control.

Manufacturing Capabilities Include:

• Automatic tablet compression machines
• High-speed blister packing lines
• Fluid-bed granulation systems
• Coating equipment for film- and sugar-coated tablets
• Dust-free environments with controlled humidity and temperature
• Dedicated facilities for oral antidiabetics and chronic therapies

Our infrastructure allows us to offer both bulk manufacturing and custom-packaged branded products for diverse distribution models.

Quality Control and Assurance

BluepillExpress is committed to global quality standards at every step of the manufacturing process. Our QA/QC protocols are aligned with international regulatory frameworks to ensure patient safety and therapeutic consistency.

QC Measures Include:

• Raw material and API testing
• In-process checks: tablet weight, hardness, friability, disintegration time
• Final product testing: assay, dissolution profile, impurity levels, uniformity of content
• Microbiological testing and contamination control
• Stability testing under ICH Zone II and Zone IVb conditions
• Complete documentation: BMRs, CoA, MSDS, and packaging records

We conduct random and routine audits to maintain a zero-defect policy and ensure full traceability across all batches.

Shelf Life and Storage Conditions

• Shelf Life: Typically 24 to 36 months
• Storage Conditions: Store below 25°C, protected from moisture and sunlight
• Packaging Materials: HDPE containers, strip packs, or blister packs with aluminum/aluminum or aluminum/PVC layers

Packaging is tailored to withstand the environmental challenges of tropical, humid, and high-temperature regions.

Packaging and Private Labeling

BluepillExpress offers fully customizable packaging options and private-label branding for Glibenclamide tablets to support retail, institutional, or government distribution.

Packaging Formats:

• Blister packs: 10×10, 10×15, or 1×10 configurations
• Strip packs or bulk packs for hospitals or tenders
• Outer cartons with multilingual artwork
• Custom inner leaflet and brand-specific design support
• Tamper-evident, serialized, and barcoded packs on request

We cater to both prescription (Rx) and over-the-counter (OTC) regulatory models depending on the destination country’s classification.

Regulatory Documentation and Support

Our regulatory team is experienced in product registration and submission processes across multiple global markets.

Documents Provided Include:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Certificate of Analysis (CoA)
• Product Dossiers in CTD/ACTD formats
• Bioequivalence studies (if required)
• Batch Manufacturing Record (BMR)
• Master Formula Record (MFR)
• Material Safety Data Sheet (MSDS)

We assist clients through regulatory review processes, dossier preparation, and variation management to ensure swift approvals.

Export & Logistics Solutions

BluepillExpress is a trusted name in pharmaceutical export logistics, managing Glibenclamide shipments with efficiency and transparency.

Logistics Services Include:

• International air and sea freight coordination
• Coordination with inspection agencies (SGS, Intertek, Bureau Veritas)
• Temperature- and humidity-controlled shipment options
• Real-time tracking and document support
• International export documentation (invoice, packing list, COO, etc.)

Our supply chain experts ensure on-time delivery of consignments to clients across Africa, Asia, and Latin America.

Target Market Segments

Our Glibenclamide manufacturing is suitable for:

• Private-label brands seeking high-quality antidiabetics
• Government tenders and public health procurement agencies
• Hospitals and medical institutions
• Retail pharmacy distribution
• NGOs and humanitarian health programs

We can also assist with formulation variants for special-use programs, such as fixed-dose combinations or pediatric adaptations.

Why Choose BluepillExpress for Glibenclamide Manufacturing?

• WHO-GMP certified, quality-driven manufacturing
• Reliable supply of high-quality, affordable antidiabetics
• Expertise in international compliance and regulatory affairs
• Customized branding and packaging options
• Capacity to fulfill both high- and low-volume orders
• Efficient and ethical manufacturing practices
• Dedicated account managers for seamless communication and service

Whether you are building a chronic disease care portfolio or supplying institutional markets, BluepillExpress ensures consistent quality, regulatory clarity, and business growth support.

Conclusion

Glibenclamide remains a cornerstone therapy in the management of type 2 diabetes, particularly in low-resource and developing healthcare settings. Its affordability, efficacy, and once-daily dosing make it an indispensable tool in the fight against diabetes-related complications.

At BluepillExpress, we combine pharmaceutical expertise, world-class infrastructure, and global regulatory knowledge to offer dependable third-party manufacturing services for Glibenclamide. From formulation to final packaging and international shipping, we are committed to being your long-term manufacturing partner in delivering accessible healthcare solutions.