Glipizide

Diabetes mellitus, particularly Type 2 Diabetes (T2DM), has emerged as a global health epidemic, requiring safe, effective, and affordable long-term therapeutic solutions. Among the most widely prescribed and clinically established medications in this category is Glipizide, a second-generation sulfonylurea that continues to play a key role in managing blood glucose levels in patients with T2DM.

BluepillExpress, a WHO-GMP-certified third-party pharmaceutical manufacturer, offers comprehensive third-party manufacturing services for Glipizide tablets, ensuring global standards of quality, consistency, and affordability. We specialize in large-scale production, private-labeling, bulk supply, and export-ready formulations tailored for regulated and semi-regulated markets.

What is Glipizide?

Glipizide is a second-generation sulfonylurea oral antidiabetic agent used for the treatment of Type 2 Diabetes Mellitus. It functions by stimulating insulin secretion from functioning pancreatic beta cells, thereby improving glycemic control in patients whose blood sugar cannot be adequately managed through diet and exercise alone.

Its rapid onset of action, shorter half-life (compared to other sulfonylureas), and lower risk of prolonged hypoglycemia make it particularly suitable for elderly patients, those with mild renal impairment, and individuals at risk of hypoglycemic episodes.

Therapeutic Class

• Oral Hypoglycemic Agent
• Sulfonylurea (Second Generation)
• Antidiabetic – Blood Glucose Lowering Drug

Key Benefits of Glipizide

1. Rapid and Effective Blood Glucose Control

Stimulates endogenous insulin secretion to quickly reduce fasting and postprandial blood glucose levels.

2. Well-Tolerated in Long-Term Use

A safe and cost-effective long-term option for managing Type 2 Diabetes, especially in resource-limited settings.

3. Lower Risk of Prolonged Hypoglycemia

Shorter half-life reduces the risk of extended hypoglycemic episodes, especially in comparison to longer-acting sulfonylureas like glyburide.

4. Economical and Widely Prescribed

Trusted in clinical guidelines and widely used in both public and private healthcare systems.

5. Flexible Dosing

Available in multiple strengths, making it easier to tailor therapy for individual patient needs and glycemic targets.

Indications

Glipizide is indicated for:

• Monotherapy in Type 2 Diabetes Mellitus when diet and exercise alone are insufficient
• Adjunct therapy with metformin or other antidiabetics for patients requiring combination treatment
• Substitution therapy for patients intolerant to or uncontrolled on other sulfonylureas
• Step-down treatment when transitioning from insulin in selected stable Type 2 patients

Glipizide is not indicated for use in Type 1 diabetes, diabetic ketoacidosis, or as an initial therapy in patients with severely impaired pancreatic function.

Available Dosage Forms and Strengths

BluepillExpress manufactures Glipizide in various strengths and formulations, catering to both international and domestic market needs.

Standard Dosages:

• Glipizide 2.5 mg tablets
• Glipizide 5 mg tablets
• Glipizide 10 mg tablets

Form Options:

• Immediate-release (IR) tablets
• Extended-release (ER) tablets (on request)
• Sugar-free and film-coated tablets for better compliance
• Fixed-Dose Combinations with Metformin (available upon request)

All tablets are manufactured using USP/BP/IP grade APIs under validated manufacturing processes that ensure dose uniformity, stability, and bioavailability.

Dosage and Administration

Initial Dose:

• 5 mg once daily, 30 minutes before breakfast

Titration:

• Dose may be increased by 2.5–5 mg increments at weekly intervals
• Usual maintenance dose: 5–10 mg/day
• Maximum dose: 20 mg/day (immediate release); 10 mg/day (extended-release)

Special Considerations:

• Administer before meals to optimize insulin secretion
• Elderly and renal-compromised patients may require lower starting doses

Pharmacokinetics

• Absorption: Rapid and complete
• Onset of action: ~30 minutes
• Peak plasma levels: 1–3 hours
• Half-life: ~2–4 hours (immediate release)
• Duration: 12–24 hours depending on formulation
• Excretion: Primarily hepatic metabolism and renal excretion

This profile allows for once or twice-daily dosing with effective glycemic control.

Mechanism of Action

Glipizide stimulates insulin release by:

• Binding to ATP-sensitive potassium (K⁺) channels on pancreatic beta cells
• Causing depolarization and opening of calcium channels
• Leading to increased calcium influx, which triggers insulin granule exocytosis

This enhances insulin secretion, especially in response to meals, making it effective in managing postprandial hyperglycemia.

Manufacturing Capabilities

BluepillExpress operates with cutting-edge WHO-GMP certified facilities to manufacture Glipizide tablets under strict quality controls.

Infrastructure Includes:

• High-speed tablet compression and coating machines
• De-dusting, polishing, and inspection systems
• Precision granulation and blending units
• In-house analytical, microbiology, and stability labs
• Dedicated air handling for cleanroom operations in tablet production

We support bulk manufacturing, white-label packaging, and custom dosage development, ensuring flexibility and speed in order fulfillment.

Packaging and Labeling

We provide market-specific packaging options designed for safety, stability, and compliance.

Primary Packaging:

• Blister packs (PVC/Alu or Alu-Alu)
• HDPE bottles with desiccant (hospital supply/bulk use)

Secondary Packaging:

• Mono cartons with multilingual artwork
• Leaflets with dosing instructions and precautions
• Optional color-coded packs for different strengths
• QR code, barcode, and serialization options as per destination requirements

Custom design and branding support is available for private label, institutional, and OTC clients.

Quality Assurance and Compliance

Every batch of Glipizide tablets manufactured by BluepillExpress undergoes strict GMP-compliant quality control and testing.

Certifications:

• WHO-GMP
• ISO 22000:2018
• Indian FDA
• FSSAI (if in combination with dietary ingredients)

Testing Parameters:

• Assay and content uniformity
• Dissolution and disintegration
• Microbial limit test
• Impurity profiling (related substances)
• Real-time and accelerated stability testing under ICH guidelines

We provide a full Certificate of Analysis (CoA) and Batch Manufacturing Record (BMR) for every batch shipped.

Regulatory Documentation Support

We offer complete documentation and technical support to facilitate your product registration or export needs.

Available Documents:

• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate (FSC)
• Certificate of Origin (COO)
• MSDS (Material Safety Data Sheet)
• Product Dossier (CTD or ACTD format)
• Real-time stability data
• Label and artwork files for regulatory submissions

We have successfully supported registrations across Africa, Southeast Asia, CIS, Middle East, and Latin America.

Export and Logistics

Our dedicated export division ensures smooth and timely delivery of your Glipizide products, globally.

• Logistics supported via air and sea freight
• Shipping terms: EXW, FOB, CIF, DDP
• Packaging options to withstand temperature and humidity changes
• Documentation for customs clearance, pharma audits, and regulatory filing
• Consolidated bulk shipment options available

Minimum Order Quantities and Lead Times

Product Form	MOQ	Lead Time
Glipizide Tablets (Any Strength)	100,000 tablets	20–25 working days
Custom Packaging & Branding	50,000 tablets	25–30 working days
Pilot Batches / Samples	20–50 units	7–10 working days

Lead times may vary slightly based on regulatory requirements, branding, or formulation customization.

Market Demand and Opportunity

Glipizide continues to hold a prominent position in:

• Public health programs targeting diabetes management
• NGO and government tenders for oral hypoglycemics
• Private-label brands in diabetes-focused portfolios
• Retail pharmacies and e-commerce pharmacy platforms
• Export markets across Asia, Africa, CIS, and Latin America

Its affordability, availability in multiple doses, and proven effectiveness ensure sustained global demand.

Ideal Business Partners

We work with:

• Generic medicine marketers
• Private-label diabetes care brands
• Hospital procurement departments
• Government and NGO health projects
• E-pharmacy platforms and digital health providers
• Distributors focused on regulated and semi-regulated markets

Whether your goal is to launch a new brand, fulfill a tender contract, or expand into international markets, we deliver customized manufacturing solutions that align with your strategy.

Why Choose BluepillExpress?

• WHO-GMP certified, export-focused facilities
• End-to-end support from formulation to documentation
• Competitive pricing with no compromise on quality
• Proven experience in diabetes and chronic disease therapy manufacturing
• Regulatory-ready dossiers for fast market entry
• Reliable production timelines and global logistics coverage

Conclusion

Glipizide remains a cornerstone in the treatment of Type 2 Diabetes Mellitus due to its reliable glycemic control, affordability, and safety. Whether used alone or in combination, it continues to be an indispensable medication in both public health and private healthcare systems.

As your trusted third-party manufacturing partner, BluepillExpress provides the infrastructure, expertise, and compliance needed to bring high-quality Glipizide products to your target markets with confidence.