Metformin Hydrochloride

Metformin Hydrochloride is a globally recognized oral antihyperglycemic agent belonging to the biguanide class, used as a first-line treatment for Type 2 diabetes mellitus. Its mechanism of action, efficacy, safety profile, and cost-effectiveness make it an essential medicine in both developed and developing healthcare systems.

At BluepillExpress, we offer WHO-GMP-certified third-party manufacturing services for Metformin Hydrochloride in multiple dosage strengths and formulations. Our commitment to precision, compliance, and customer satisfaction makes us a reliable manufacturing partner for pharmaceutical brands, hospitals, NGOs, government institutions, and international distributors.

Product Overview

Generic Name: Metformin Hydrochloride
Pharmacological Class: Biguanide
Therapeutic Use: Oral Antidiabetic Agent (Type 2 Diabetes Mellitus)
Mechanism of Action: Reduces hepatic glucose production, increases insulin sensitivity, and improves peripheral glucose uptake.

Available Dosage Forms and Strengths

Immediate Release Tablets (IR):

• Metformin HCl 250 mg
• Metformin HCl 500 mg
• Metformin HCl 850 mg
• Metformin HCl 1000 mg

Extended Release Tablets (XR / SR):

• Metformin XR 500 mg
• Metformin XR 750 mg
• Metformin XR 1000 mg

Fixed Dose Combinations (on request):

• Metformin + Glimepiride
• Metformin + Gliclazide
• Metformin + Vildagliptin
• Metformin + Sitagliptin
• Metformin + Dapagliflozin
• Metformin + Pioglitazone

All strengths are available in blister, strip, or bottle packaging tailored to local and export market demands.

Packaging Options

• Alu-Alu or PVC-Alu blister packs
• HDPE bottles with child-resistant caps
• Bulk pack options for institutional or hospital supply
• Outer cartons with multilingual labeling and inserts
• Private label branding with regulatory artwork support

Therapeutic Indications

Metformin Hydrochloride is indicated for:

• Management of Type 2 Diabetes Mellitus, especially in overweight and obese patients
• Monotherapy or in combination with other oral antidiabetic agents or insulin
• Prevention of type 2 diabetes in high-risk individuals (impaired glucose tolerance)
• Polycystic Ovary Syndrome (PCOS) (off-label)
• Gestational Diabetes Mellitus (GDM) (under medical supervision)

Metformin is essential in glycemic control, weight management, and cardiovascular risk reduction for diabetic patients.

Mechanism of Action

Metformin works primarily by:

• Decreasing hepatic glucose production (gluconeogenesis inhibition)
• Enhancing insulin sensitivity at peripheral tissues (muscle and fat)
• Promoting glucose uptake and utilization by cells
• Delaying intestinal absorption of glucose

Unlike sulfonylureas, it does not stimulate insulin secretion, reducing the risk of hypoglycemia. Metformin also contributes to modest weight loss or weight neutrality, making it ideal for obese patients.

Pharmacokinetics

• Absorption: ~50–60% (IR); ~70% (XR)
• Time to Peak Plasma Concentration: ~2.5 hours (IR); ~7 hours (XR)
• Half-life: 6.2 hours
• Excretion: Unchanged via kidneys
• Bioavailability: Not protein-bound; primarily renal elimination

Due to its pharmacokinetics, Metformin requires caution in renal impairment, and dose adjustments are made accordingly.

Why Choose BluepillExpress for Metformin Manufacturing?

1. WHO-GMP Certified Manufacturing Facilities

BluepillExpress operates state-of-the-art pharmaceutical manufacturing plants, including:

• Dedicated tablet compression units (IR and SR)
• High-speed granulation and drying equipment
• Coating, blistering, and bulk packing lines
• Controlled temperature and humidity zones
• Automated material handling and in-process monitoring

All manufacturing is conducted under cGMP, ISO 9001:2015, and Schedule M compliant environments.

2. Formulation Capabilities and R&D Support

We offer custom formulations including:

• Immediate Release (IR) and Extended Release (XR/SR) profiles
• Pellet and matrix tablet technologies for controlled release
• Sugar-free and film-coated options for better patient compliance
• Taste-masked chewable or dispersible formulations (on request)
• Low-dose pediatric formulations (available upon customization)

Our R&D and formulation team assists clients with product differentiation, dissolution optimization, and bioequivalence support for regulated markets.

Quality Control and Assurance

BluepillExpress adheres to the highest quality standards for all raw materials, in-process production, and finished goods.

Tests Conducted:

• Assay and content uniformity
• Dissolution and disintegration
• Tablet hardness and friability
• Microbial limit testing
• Impurity profiling and heavy metal testing
• Residual solvents and moisture content
• Stability testing (accelerated and long-term)

All tests follow IP, USP, and BP standards and are backed by validated Standard Operating Procedures (SOPs).

Regulatory and Documentation Support

We provide full regulatory assistance for Metformin, including:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Product Dossiers (CTD / ACTD format)
• Free Sale Certificate (FSC)
• Stability Data (Zone II and IV)
• Certificate of Origin (CoO)
• Method of Analysis (MoA)
• Material Safety Data Sheet (MSDS)
• WHO-GMP and ISO certificates

We support product registration and documentation for domestic, semi-regulated, and regulated markets globally.

Private Label and Contract Branding

We offer custom private-label manufacturing services:

• Brand name and logo incorporation
• Custom-designed packaging (blister cards, cartons, inserts)
• Multilingual text support
• Patient information leaflets and tamper-proof labeling
• QR code, serialization, and barcoding (as per export requirements)
• Institutional branding for hospitals or government supply chains

Our design and regulatory teams ensure fast artwork turnaround and full compliance with your target country’s regulations.

Export and Global Reach

BluepillExpress has successfully exported Metformin to over 35 countries, including:

• Africa: Nigeria, Kenya, Ghana, South Africa
• Southeast Asia: Vietnam, Myanmar, Philippines
• CIS and Middle East: Uzbekistan, Iraq, Yemen
• Latin America: Peru, Bolivia, Honduras

Our export services include:

• Freight forwarding via air or sea
• Pre-shipment inspection (SGS, Bureau Veritas, Intertek)
• Cold chain management (if required)
• Customized export documentation
• Support for MOH approvals and customs clearance

We deliver institutional tenders, retail-ready packs, and custom bulk shipments worldwide.

Third-Party Manufacturing Process Workflow

Here’s how the Metformin third-party manufacturing process works:

1. Product Consultation & NDA Signing
   • Initial discussion of strength, form, packaging, and MOQ
2. Commercial Quotation & Agreement
   • Cost, timelines, documentation, and compliance terms confirmed
3. Sample Development / R&D (if required)
   • Prototype production for client feedback
4. Artwork and Packaging Approval
   • Branding and regulatory text finalized
5. GMP Batch Manufacturing
   • Full-scale production in GMP-certified units
6. Quality Assurance & Documentation
   • CoA, batch release reports, and all compliance papers
7. Packing & Dispatch
   • Final shipment with coordination of freight and export processes

Typical Lead Time: 30–45 working days from artwork and regulatory approval

Target Client Segments

Our Metformin manufacturing services are ideal for:

• Generic pharmaceutical brands
• Diabetology-focused marketing companies
• Government and institutional healthcare suppliers
• NGOs and international aid organizations
• Hospital procurement divisions
• Online pharmacy retailers and e-commerce wellness platforms

We serve clients with low MOQs for private label launches as well as high-volume production for national programs and tenders.

Advantages of Choosing BluepillExpress

• WHO-GMP, ISO 9001:2015 certified plants
• Full spectrum of Metformin dosage strengths and release profiles
• Regulatory documentation ready for international submissions
• Affordable pricing and competitive turnaround times
• Strict quality assurance with global pharmacopeia compliance
• End-to-end support from product development to logistics
• Transparent communication and dedicated account management

Conclusion

Metformin Hydrochloride remains the gold standard in the treatment of Type 2 Diabetes Mellitus. As diabetes prevalence increases globally, the demand for safe, effective, and affordable Metformin products continues to rise in both public and private healthcare sectors.

BluepillExpress is your reliable third-party manufacturing partner for Metformin, offering technologically advanced production, regulatory expertise, and personalized branding. Whether you’re building a retail diabetic care range or fulfilling a large-scale healthcare tender, we provide everything you need—from concept to container.