Gliclazide

Gliclazide is an oral hypoglycemic agent belonging to the sulfonylurea class, widely prescribed for the management of Type 2 Diabetes Mellitus (T2DM). Renowned for its dual action of stimulating insulin secretion and improving blood rheology, Gliclazide is highly effective in maintaining long-term glycemic control in diabetic patients.

At BluepillExpress, we provide third-party manufacturing for high-quality Gliclazide tablets, serving both branded and generic pharmaceutical markets. Our state-of-the-art WHO-GMP certified production units, adherence to international regulatory standards, and flexible private-label options allow clients to scale and supply Gliclazide to both domestic and global markets with confidence.

Product Overview

Generic Name: Gliclazide
Therapeutic Class: Oral Antidiabetic Agent (Sulfonylurea)
Indication: Type 2 Diabetes Mellitus (Non-Insulin Dependent Diabetes)

Available Dosage Forms:

• Gliclazide Immediate Release (IR) Tablets
• Gliclazide Modified Release (MR) Tablets
• Gliclazide Extended Release (ER) Tablets

Common Strengths Manufactured:

• Gliclazide IR: 40 mg, 80 mg
• Gliclazide MR/ER: 30 mg, 60 mg

Packaging Configurations:

• Blister Packs (10×10)
• Alu-Alu or PVC-Alu Blisters
• Bulk Packs for institutional supply
• Tamper-evident mono-cartons with multilingual labeling
• QR code and serialization compliant packaging available

Pharmacopoeial Standards: IP / BP / USP / EP (as per client specification and market requirement)

Mechanism of Action

Gliclazide acts primarily by stimulating insulin secretion from pancreatic β-cells. It binds to the sulfonylurea receptor (SUR1) on the pancreatic cell membrane, leading to:

• Closure of ATP-sensitive potassium channels
• Membrane depolarization
• Calcium influx
• Subsequent insulin release

In addition, Gliclazide has extra-pancreatic benefits such as:

• Improving endothelial function
• Reducing platelet aggregation
• Enhancing fibrinolytic activity
• Offering potential vascular protective effects

This makes Gliclazide an ideal choice in diabetic patients at risk for cardiovascular complications.

Indications

Gliclazide is indicated as monotherapy or in combination with other antidiabetic agents for:

• Type 2 Diabetes Mellitus (when diet, exercise, and weight loss alone are insufficient)
• Glycemic control in adults with stable insulin secretion capacity
• Patients intolerant to or inadequately controlled on metformin

Modified-release formulations are especially effective in reducing glycemic variability and achieving 24-hour glucose control with once-daily dosing.

Dosage and Administration

Immediate Release (IR):

• Starting dose: 40–80 mg once or twice daily, before meals
• Max daily dose: 320 mg (usually divided into two doses)
• Dose titration based on blood glucose monitoring

Modified/Extended Release (MR/ER):

• Starting dose: 30 mg once daily with breakfast
• Usual maintenance: 30–120 mg/day
• Max dose: 120 mg/day
• Not intended for crushing or splitting

Special Populations:

• Elderly: Lower starting dose recommended
• Renal impairment: Use cautiously, monitor glucose regularly
• Hepatic impairment: Contraindicated in severe cases

Pharmacokinetics

Immediate Release Formulations:

• Absorption: Rapid and complete
• Onset of action: Within 2 hours
• Peak concentration: 4–6 hours
• Half-life: ~10–12 hours

Modified/Extended Release Formulations:

• Slow, consistent absorption over 24 hours
• Once-daily dosing maintains stable plasma levels
• Reduced risk of hypoglycemia compared to IR forms

Metabolized primarily in the liver, with renal excretion of inactive metabolites.

Clinical Advantages

• Proven efficacy in lowering fasting and postprandial glucose
• Low risk of hypoglycemia, especially with MR formulations
• Cardiovascular protection observed in multiple studies
• Suitable for elderly patients and long-term therapy
• Cost-effective compared to newer antidiabetic agents
• Widely accepted in government tenders and institutional protocols

Why Choose BluepillExpress for Gliclazide Manufacturing?

1. WHO-GMP Certified Manufacturing Facilities

Our facilities include:

• Dedicated production zones for oral solids
• High-speed compression and coating machines
• Controlled temperature and humidity areas for stability
• Automatic blister packing, carton filling, and labeling lines
• Integrated BMR/BPR systems and batch tracking

2. Flexible Formulation Options

We offer:

• Gliclazide IR and MR/ER tablets in multiple strengths
• Sugar-free coating for diabetic compatibility
• Film-coated or uncoated tablets based on market preference
• Custom packaging for retail, institutional, and export clients

3. Regulatory and Documentation Support

Our documentation team provides:

• COA, COPP, FSC, WHO-GMP Certificates
• CTD / ACTD dossiers for product registration
• Stability studies (real-time and accelerated)
• Labeling as per MOH, EMA, USFDA, or other authority requirements
• QR-coded and serialized packaging (as per traceability laws)

4. Global Export Capability

We export to:

• Africa: Nigeria, Kenya, Ethiopia, Sudan
• Asia: Bangladesh, Myanmar, Vietnam, Cambodia
• Middle East: Yemen, Jordan, Iraq, UAE
• CIS and LATAM: Uzbekistan, Bolivia, Peru, Kazakhstan

BluepillExpress ensures:

• International documentation compliance
• Temperature-controlled shipping (if required)
• Customs clearance support and prompt delivery

Quality Assurance and Quality Control

We follow stringent QC and QA protocols to maintain consistency across batches.

Key Quality Tests Include:

• API assay by HPLC
• Uniformity of content and weight variation
• Dissolution and disintegration
• Friability and hardness tests
• Stability testing under ICH guidelines
• Microbial load testing (for coated tablets)

GMP audits and in-process validation ensure compliance with global standards and market readiness.

Manufacturing Process Flow at BluepillExpress

1. Project Initiation:
   Finalize dosage form, strength, and regulatory scope
2. Formulation & Sampling:
   Trial batch development and COA-based approval by the client
3. Commercial Batch Production:
   Production under cGMP conditions with in-process controls
4. Quality Testing & Release:
   Full panel testing with QA batch release documentation
5. Packaging & Dispatch:
   Packaged as per order with branding, serialization, and export compliance
6. Post-Supply Support:
   Includes assistance with MOH registration, tenders, and dossier submissions

Ideal Client Profiles

Our Gliclazide third-party manufacturing is ideal for:

• Pharmaceutical marketing companies
• Government health departments and procurement agencies
• Hospitals and clinics requiring generic brands
• NGOs and international donor programs
• Private label clients for diabetic care
• International distributors and tenders

Global Market Insights

• Type 2 Diabetes affects over 500 million people globally, driving massive demand for affordable oral antidiabetics
• Sulfonylureas like Gliclazide remain first-line agents in low- and middle-income countries due to cost-effectiveness
• Modified-release formulations are gaining popularity for once-daily use and better compliance
• Governments and NGOs prefer well-documented, WHO-GMP certified Gliclazide for national programs

BluepillExpress remains a trusted partner in supplying high-volume, high-compliance diabetic formulations for every scale—from local marketing to large-scale public tenders.

Conclusion

Gliclazide is a time-tested and effective oral antidiabetic with an excellent safety profile, particularly in its modified-release form. As the global burden of diabetes continues to rise, access to high-quality, affordable, and scalable Gliclazide solutions becomes essential.

BluepillExpress is proud to offer end-to-end third-party manufacturing for Gliclazide with:

• WHO-GMP certified infrastructure
• Scalable production
• Private-label customization
• Regulatory and export support