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Valsartan + Amlodipine Besilate is a fixed-dose combination of two well-established antihypertensive agents that target different physiological mechanisms to effectively reduce elevated blood pressure. This combination offers improved blood pressure control, increased patient compliance, and reduced cardiovascular risks compared to monotherapy.
At BluepillExpress, we proudly offer third-party manufacturing of Valsartan + Amlodipine Besilate in multiple strengths and dosage forms. As a WHO-GMP certified pharmaceutical manufacturer and global exporter, we serve clients across regulated, semi-regulated, and developing markets. Our robust infrastructure, strict quality protocols, and regulatory expertise ensure that every product leaving our facility meets international standards of safety, efficacy, and consistency.
Product Overview
Product Name: Valsartan + Amlodipine Besilate
Therapeutic Class: Antihypertensive – Angiotensin II Receptor Blocker (ARB) + Calcium Channel Blocker (CCB)
Available Dosage Forms and Strengths:
- Tablets:
- Valsartan 80 mg + Amlodipine 5 mg
- Valsartan 160 mg + Amlodipine 5 mg
- Valsartan 160 mg + Amlodipine 10 mg
- Customized strengths/formulations available upon request
Route of Administration: Oral
Packaging Options:
- Blister Packs: Alu-Alu / PVC-Alu (10×10, 3×10, or 1×10)
- Bottle Packs: HDPE or PET bottles (for bulk institutional supply)
- Mono-carton with leaflet (as per customer/regulatory need)
Pharmacological Overview
Valsartan
Valsartan is an angiotensin II receptor blocker (ARB) that selectively inhibits the AT1 receptor, thereby preventing vasoconstriction and aldosterone secretion. This leads to a reduction in systemic vascular resistance, lowering blood pressure without affecting heart rate.
Amlodipine Besilate
Amlodipine is a dihydropyridine calcium channel blocker (CCB) that inhibits calcium ion influx into vascular smooth muscle and myocardial cells, resulting in vasodilation and decreased peripheral resistance. It also has mild anti-anginal effects.
The combination provides synergistic antihypertensive effects, reduces cardiovascular morbidity, and is well tolerated over long-term use.
Mechanism of Action
- Valsartan blocks the action of angiotensin II on AT1 receptors, causing vasodilation and reducing aldosterone-mediated sodium and water retention.
- Amlodipine inhibits L-type calcium channels, reducing vascular tone and enhancing arterial compliance.
Together, they provide complementary mechanisms to reduce blood pressure, improve arterial flexibility, and enhance endothelial function. The dual mechanism is particularly beneficial for patients with stage 2 hypertension, left ventricular hypertrophy, or comorbid conditions like diabetes and chronic kidney disease.
Indications
This combination is widely prescribed for:
- Essential (primary) hypertension
- Stage 1 and stage 2 hypertension in adults
- Hypertension with high cardiovascular risk
- Patients requiring dual therapy for uncontrolled blood pressure
- Patients with previous intolerance to ACE inhibitors
Optional off-label uses in select regions include cardioprotective therapy in high-risk cardiac patients.
Pharmacokinetic Profile
| Parameter | Valsartan | Amlodipine |
|---|---|---|
| Bioavailability | ~25% | ~64% |
| Time to Peak (Tmax) | 2–4 hours | 6–12 hours |
| Half-life | ~6 hours | 30–50 hours |
| Protein Binding | 95% | 93% |
| Excretion | Mainly fecal | Renal and fecal |
Due to Amlodipine’s long half-life, once-daily dosing is adequate for 24-hour BP control.
Advantages of Fixed-Dose Combination
- Improved compliance through once-daily dual therapy
- Reduced pill burden, especially beneficial for elderly patients
- Additive blood pressure-lowering effect without increasing adverse effects
- Better tolerability and safety profile compared to other dual therapies
- Effective in salt-sensitive and high-renin hypertension populations
This combination is included in many national and international treatment guidelines, including JNC-8, ESC/ESH, and NICE.
Why Choose BluepillExpress for Manufacturing?
1. Certified, Compliant, and Scalable Facilities
Our manufacturing units are WHO-GMP, ISO 9001:2015, and FSSAI certified, with capacity for large-scale production of solid oral dosage forms. Each facility is equipped with:
- Advanced granulation, compression, and coating machinery
- Controlled environmental conditions (HVAC)
- Automated tablet sorting, packaging, and labeling lines
- In-process monitoring for uniformity and weight variation
2. End-to-End Quality Control
We employ rigorous in-house analytical testing backed by our quality assurance systems. Each batch undergoes:
- Assay and content uniformity testing
- Dissolution and disintegration tests
- Hardness, friability, and weight variation
- Impurity profiling (using HPLC/GC)
- Microbial testing (if required)
- Stability studies under ICH guidelines
All results are documented as per international standards for submission and validation.
3. Regulatory and Documentation Support
We provide clients with all necessary regulatory documents for product registration, including:
- Certificate of Analysis (CoA)
- Batch Manufacturing Records (BMR)
- Method of Analysis (MoA)
- Product Specifications
- Certificate of Origin (CoO)
- Free Sale Certificate
- CTD/ACTD Dossiers (available on request)
- Material Safety Data Sheet (MSDS)
- Bioequivalence support (when required)
Our regulatory team supports clients in obtaining approvals from health authorities across Asia, Africa, CIS, Latin America, and the Middle East.
Packaging and Private Labeling Services
We offer full private label manufacturing support for both domestic and export clients:
- Customized blister or bottle packaging with client branding
- Multilingual artwork as per country requirement
- Serialization, QR coding, and barcoding (as per DSCSA/EU-FMD)
- Mono-cartons with optional patient information leaflets
- Eco-friendly packaging options for sustainability-conscious brands
We also assist with design and artwork development, ensuring fast time to market.
Global Supply and Export Expertise
BluepillExpress has established supply chains in over 35 countries, providing high-quality pharmaceuticals to:
- Public health institutions
- Government tender suppliers
- NGOs and donor-funded programs
- Hospital procurement systems
- Retail pharmacy brands
- Licensed importers and distributors
Our export services include:
- Complete regulatory filing assistance
- International logistics coordination
- Cold chain (if required) and controlled temperature shipping
- Third-party pre-shipment inspections (on demand)
Third-Party Manufacturing Process
Our streamlined third-party manufacturing workflow ensures a hassle-free experience:
- Product Finalization
- Strength, form, flavor (if applicable), branding, and packaging preferences
- Quotation and Agreement
- Commercial terms, MOQs, timelines, and compliance documentation
- Documentation & Sample Development
- Trial batches and packaging mock-ups for client approval
- Commercial Batch Production
- Manufacturing with real-time quality checks and process validation
- Packing and Labeling
- Custom branded primary and secondary packaging
- Shipping and Regulatory Documents
- Final delivery with full export documentation support
Turnaround Time: 30–45 days depending on customization and batch size.
Target Clients
- Marketing authorization holders looking to expand their cardiovascular product range
- Pharmaceutical companies catering to retail or hospital demand
- Distributors participating in government and institutional tenders
- Chain pharmacies launching in-house brands
- Telehealth and e-pharmacy platforms seeking trusted private labels
Our Valsartan + Amlodipine Besilate range aligns with WHO, JNC, and national hypertension management programs and remains in consistent global demand.
Advantages of Partnering with BluepillExpress
- Global-standard quality with cost-effective pricing
- WHO-GMP certified, scalable infrastructure
- High production capacity for fast turnarounds
- Comprehensive regulatory, branding, and export support
- Transparent and confidential client relationships
- Multi-regional market experience with adaptive labeling and compliance
Conclusion
As cardiovascular disease remains a leading global health burden, Valsartan + Amlodipine Besilate offers an effective and trusted solution for managing hypertension and reducing cardiovascular risks. With increasing demand for fixed-dose combinations that enhance patient outcomes, this formulation is an essential part of any cardiovascular product portfolio.
At BluepillExpress, we stand ready to support your brand with flexible, quality-driven, and globally compliant third-party manufacturing services. Whether you’re launching in a new market, expanding your current offerings, or fulfilling institutional demand, we provide the infrastructure, expertise, and reliability to scale your business effectively.
