Amlodipine + Losartan

Hypertension remains one of the leading causes of cardiovascular morbidity and mortality globally. The use of fixed-dose combination (FDC) therapies like Amlodipine + Losartan has emerged as a highly effective approach for patients requiring dual antihypertensive treatment. This combination, involving a calcium channel blocker and an angiotensin II receptor blocker (ARB), provides synergistic blood pressure control while improving patient compliance and therapeutic outcomes.

At BluepillExpress, we specialize in the third-party manufacturing of combination medications, including high-demand cardiovascular products like Amlodipine + Losartan. As a WHO-GMP certified pharmaceutical company and global exporter, we offer precision manufacturing, regulatory support, and a seamless supply chain solution for your brand. Whether you serve regulated or semi-regulated markets, BluepillExpress provides the reliability and scalability to support your growth in the cardiovascular segment.

Product Overview

Generic Name: Amlodipine + Losartan
Therapeutic Category: Antihypertensive Combination
Pharmacological Class:
Amlodipine – Calcium Channel Blocker (Dihydropyridine class)
Losartan – Angiotensin II Receptor Blocker (ARB)

Available Formulations:

• Amlodipine 5 mg + Losartan 50 mg Tablets
• Amlodipine 5 mg + Losartan 25 mg Tablets
• Amlodipine 10 mg + Losartan 50 mg Tablets
• Amlodipine 10 mg + Losartan 100 mg Tablets
• Other combinations as per custom specifications

Packaging:

• Blister packs (PVC/Alu or Alu/Alu)
• Customized mono cartons with or without inserts
• 10×10, 10×15, or 1×30 formats based on market needs

Pharmacopoeial Compliance: IP / USP / BP (as per requirement)
Manufacturing Type: Private Label / Contract Manufacturing / Export Bulk Supply

Mechanism of Action

The Amlodipine + Losartan combination targets two major pathways in blood pressure regulation:

Amlodipine: A long-acting calcium channel blocker that inhibits the influx of calcium ions into vascular smooth muscles, leading to vasodilation and reduced peripheral vascular resistance. It primarily acts on arteriolar smooth muscle to decrease systemic blood pressure.

Losartan: A selective angiotensin II receptor blocker that prevents vasoconstriction and aldosterone secretion by blocking the AT1 receptor. This leads to vasodilation, decreased sodium retention, and lowered blood pressure.

When used in combination, these two agents provide complementary and additive antihypertensive effects, improving control while minimizing side effects.

Indications

Amlodipine + Losartan is indicated for the treatment of:

• Essential (primary) hypertension
• Patients who fail to respond adequately to monotherapy with either Amlodipine or Losartan
• Hypertension associated with left ventricular hypertrophy
• Diabetic hypertensive patients (due to nephroprotective effects of Losartan)
• High-risk cardiovascular patients requiring dual therapy

The fixed-dose combination ensures better adherence, especially in chronic cases requiring long-term blood pressure management.

Dosage and Administration

Dosage should be individualized based on the patient’s clinical profile and prior treatment history.

Usual Adult Dose:

• One tablet once daily, preferably at the same time each day
• Amlodipine 5 mg + Losartan 50 mg is a common starting dose
• Dosage can be increased based on blood pressure control, up to Amlodipine 10 mg + Losartan 100 mg

No initial dose adjustment is required in elderly patients or those with mild renal impairment. However, caution is advised in patients with hepatic dysfunction or severe renal insufficiency.

Pharmacokinetics

Amlodipine:

• Bioavailability: 60–65%
• Peak plasma concentration: 6–12 hours
• Half-life: 30–50 hours
• Once-daily dosing due to long duration of action

Losartan:

• Bioavailability: ~33%
• Peak plasma levels: 1 hour
• Active metabolite (EXP3174) prolongs antihypertensive action
• Half-life: 2 hours (parent) and 6–9 hours (active metabolite)

Both agents are highly protein-bound and metabolized in the liver. Excretion occurs primarily via urine and feces.

Benefits of Amlodipine + Losartan Combination

• Dual mechanism of action for improved blood pressure control
• Lower risk of adverse effects compared to high-dose monotherapy
• Better tolerability and compliance due to once-daily dosing
• Reduced incidence of peripheral edema (Amlodipine side effect mitigated by Losartan)
• Losartan provides renal protection in diabetic hypertensive patients
• Superior clinical outcomes in cardiovascular risk reduction

Why Choose BluepillExpress for Manufacturing Amlodipine + Losartan?

WHO-GMP and ISO Certified Facilities
Our manufacturing plants are accredited by international quality standards, ensuring compliance, safety, and consistent product quality. With automated tablet compression, blistering, and packaging lines, we deliver large-scale production without compromising on precision.

Customized Formulations and Strengths
We cater to specific market needs with customized dosage strengths, FDC modifications, and packaging configurations. Flavored film coatings, breakable tablets, and combination packs can be developed on request.

Global Regulatory Support
We provide full regulatory and export documentation, including:

• Certificate of Pharmaceutical Product (COPP)
• Certificate of Analysis (COA)
• Stability data (real-time and accelerated)
• Product Technical Dossier (CTD/ACTD formats)
• Free Sale Certificate (FSC)
• Country-specific labeling and MOH registration support

Export Expertise Across Regions
We have an established track record of exporting cardiovascular formulations, including Amlodipine + Losartan, to:

• Africa (Kenya, Nigeria, Ghana, Ethiopia, Sudan)
• Southeast Asia (Philippines, Vietnam, Myanmar, Cambodia)
• Middle East (Jordan, Iraq, UAE, Yemen)
• Latin America (Bolivia, Paraguay, Dominican Republic)
• CIS (Uzbekistan, Kyrgyzstan, Tajikistan)
• Eastern Europe and select regulated markets

High-Quality Packaging Services
We offer export-ready packaging solutions including:

• Alu-Alu or PVC/Alu blisters
• Multilingual mono cartons with or without patient information leaflets
• QR-coded or serialized packaging for track-and-trace compliance
• Custom branding and private label design services
• Batch coding, holograms, tamper-evident seals for authenticity

Manufacturing and Partnership Workflow

BluepillExpress ensures a seamless and transparent third-party manufacturing process for its partners.

Step 1: Product Finalization
Product strengths, market-specific formulation requirements, and branding needs are discussed and confirmed.

Step 2: Sample Development and Approval
Pilot samples are developed and shared for testing and client feedback. Regulatory dossiers are simultaneously prepared.

Step 3: Batch Production
Commercial production is initiated in WHO-GMP compliant facilities. In-process and finished product testing ensures quality and consistency.

Step 4: Packaging and Labeling
Products are packed as per client-approved designs. All compliance information is included in secondary packaging.

Step 5: Documentation and Dispatch
Final shipment is dispatched along with full regulatory documentation for customs clearance, distribution, and product registration.

Target Markets and Clients

• Pharmaceutical companies seeking to launch cardiovascular brands
• Distributors and wholesalers in emerging and developing economies
• Government tender contractors and institutional buyers
• Retail pharmacy chains and healthcare groups
• NGOs and non-profit organizations managing chronic disease programs

With cardiovascular diseases on the rise globally, especially in urban and aging populations, demand for reliable and affordable antihypertensive FDCs like Amlodipine + Losartan is rapidly increasing. BluepillExpress is well-positioned to support this demand through dependable third-party manufacturing services.

Quality Control and Compliance

Our in-house quality control (QC) and quality assurance (QA) teams adhere to stringent protocols at each stage of production. Tests include:

• API identification and assay
• Dissolution and disintegration testing
• Uniformity of weight and content
• Microbial limit testing
• Stability testing under ICH guidelines
• Packaging integrity and labeling verification

All processes are documented in accordance with GMP, and batch records are archived for audit readiness.

Market Demand and Business Advantage

The global hypertension market is projected to exceed USD 40 billion in the next few years. Fixed-dose combinations like Amlodipine + Losartan are increasingly prescribed due to:

• Better compliance compared to separate drugs
• Reduced pill burden
• Cost-effectiveness in resource-limited settings
• Improved long-term cardiovascular outcomes

By choosing BluepillExpress as your third-party manufacturer, you gain a strategic partner with capabilities in large-scale production, regulatory navigation, and international supply chain logistics.

Conclusion

Amlodipine + Losartan is a clinically proven, well-tolerated, and highly effective antihypertensive combination with global recognition and rising market demand. As a third-party manufacturer, BluepillExpress delivers this essential cardiovascular product in world-class formulations backed by international quality standards, export support, and end-to-end manufacturing solutions.

Whether you’re a startup entering the cardiovascular market or an established brand seeking a dependable manufacturing partner, BluepillExpress offers the infrastructure, expertise, and excellence to support your growth.