IndiaMart
FIEO
Hypertension is a major global health challenge and a key risk factor for cardiovascular disease, stroke, and kidney failure. Many patients require combination therapy to achieve optimal blood pressure control. Valsartan, an angiotensin II receptor blocker (ARB), and Hydrochlorothiazide (HCTZ), a thiazide diuretic, work synergistically to lower blood pressure more effectively than either agent alone. This fixed-dose combination is widely recommended for managing moderate to severe hypertension in adults.
BluepillExpress, a WHO-GMP-certified pharmaceutical manufacturer, offers high-quality third-party manufacturing of Valsartan + Hydrochlorothiazide tablets. We specialize in scalable production for branded generics, private labels, government tenders, and export markets, with full regulatory and technical support. Our offerings meet international quality standards and are available in various strengths and packaging formats to suit global customer needs.
What is Valsartan + Hydrochlorothiazide?
Valsartan is an angiotensin II receptor blocker (ARB) that prevents the binding of angiotensin II to its receptors, thus relaxing blood vessels and lowering blood pressure. It reduces systemic vascular resistance without significantly affecting heart rate or electrolyte balance.
Hydrochlorothiazide is a thiazide diuretic that helps reduce blood pressure by promoting the excretion of sodium and water through the kidneys, thereby decreasing blood volume and vascular resistance.
The combination offers a potent, complementary mechanism of action, ideal for patients who do not achieve target blood pressure with monotherapy.
Therapeutic Class
- Antihypertensive Combination Therapy
- Angiotensin II Receptor Blocker (ARB) + Thiazide Diuretic
Key Benefits of Valsartan + Hydrochlorothiazide
1. Dual Mechanism for Effective Blood Pressure Control
Combines vasodilation from Valsartan with diuresis from Hydrochlorothiazide to reduce blood pressure efficiently.
2. Proven Cardiovascular Risk Reduction
Effective in reducing the risk of stroke, heart failure, and cardiovascular mortality in patients with uncontrolled hypertension.
3. Enhanced Patient Compliance
The fixed-dose combination improves compliance by reducing pill burden, especially beneficial in long-term therapy.
4. Suitable for High-Risk and Resistant Hypertension
Recommended for patients who do not respond adequately to monotherapy or require rapid blood pressure control.
5. Available in Multiple Strengths
Offered in a range of strengths to enable individualized dosing based on patient response and clinical guidelines.
Indications
Valsartan + Hydrochlorothiazide is indicated for:
- Treatment of essential hypertension, particularly in patients who are not adequately controlled on monotherapy.
- Management of stage 2 hypertension or high cardiovascular risk profiles requiring intensive blood pressure reduction.
- As part of combination therapy in treatment-resistant hypertension.
- Suitable as a first-line treatment in selected cases based on physician discretion.
It is approved for use in adult patients, with dosage adjusted according to response and renal function.
Available Strengths and Composition
BluepillExpress manufactures the following strengths of Valsartan + Hydrochlorothiazide tablets:
- Valsartan 80 mg + Hydrochlorothiazide 12.5 mg
- Valsartan 160 mg + Hydrochlorothiazide 12.5 mg
- Valsartan 160 mg + Hydrochlorothiazide 25 mg
- Valsartan 320 mg + Hydrochlorothiazide 12.5 mg
- Valsartan 320 mg + Hydrochlorothiazide 25 mg
Each film-coated tablet is:
- Manufactured under validated protocols for uniform content
- Compliant with USP/BP/EP standards
- Available in standard blister packs or bulk HDPE bottles
Formulations can be customized based on market-specific regulatory requirements, bioequivalence standards, and branding needs.
Dosage and Administration
Recommended Adult Dosage:
- Starting dose: 80/12.5 mg or 160/12.5 mg once daily
- Maximum dose: 320/25 mg once daily, based on clinical response
Tablets should be taken once daily with or without food. The combination is not recommended for initial therapy unless the potential benefit outweighs the risk.
Dose adjustment is required in patients with renal or hepatic impairment, and close monitoring of electrolytes and renal function is advised.
Pharmacological Profile
Valsartan:
- Bioavailability: ~25%
- Half-life: 6 hours
- Metabolism: Minimal hepatic metabolism
- Excretion: Primarily unchanged via feces and urine
Hydrochlorothiazide:
- Bioavailability: ~65–75%
- Half-life: 6–15 hours
- Metabolism: Not metabolized
- Excretion: Renal excretion of unchanged drug
The complementary pharmacokinetics support once-daily dosing with sustained antihypertensive effect over 24 hours.
Manufacturing Capabilities
BluepillExpress is equipped to handle high-volume third-party manufacturing of fixed-dose combination tablets with precise formulation techniques and high-end production technology.
Facilities Include:
- Advanced granulation, compression, and coating units
- Tablet manufacturing zones with Class 100,000 cleanroom environments
- Online tablet weight, hardness, and coating thickness monitoring
- Automatic blister packing lines for high-speed production
- Serialization and track-and-trace barcode integration
All processes follow validated batch manufacturing protocols with complete documentation.
Packaging and Labeling
We provide flexible packaging options to suit regulatory, retail, and hospital supply chain requirements.
Primary Packaging:
- Alu-Alu or PVC blister strips
- HDPE bottles with desiccants and tamper-evident caps
- Custom bulk packs for institutional use
Secondary Packaging:
- Printed mono cartons with multilingual labeling
- Instruction leaflets (PIL) as per local regulations
- Branding support for private label clients
- Serialization and QR-code tracking for export markets
We also support custom label design, multi-country packaging, and retail-ready kits.
Quality and Regulatory Compliance
Every product batch is manufactured under strict quality control protocols with full compliance to international pharmacopeial standards.
Certifications:
- WHO-GMP
- ISO 22000:2018
- FSSAI (India)
- FDA (India) Export License
- Support for CTD dossier registration and EU-GMP markets (on request)
QA & QC Testing:
- Assay and content uniformity
- Dissolution testing
- Related substances and impurity profiling
- Stability testing under ICH Zone II & IVB
- Disintegration, hardness, friability testing
Each batch is released with a Certificate of Analysis (CoA), and stability data is available for long-term studies.
Regulatory and Export Support
We assist partners with complete regulatory filing and registration support for global markets.
Documentation Includes:
- Certificate of Pharmaceutical Product (COPP)
- Free Sale Certificate (FSC)
- Certificate of Origin (COO)
- Dossiers in CTD/ACTD format (Modules 1–5)
- Product label and artwork design
- Manufacturing license and site master file
- MSDS (Material Safety Data Sheet)
Our team works with partners to fulfill local authority requirements for Latin America, CIS, Southeast Asia, MENA, and Africa.
Export and Logistics Services
We offer end-to-end export support for distributors, government buyers, and international brand owners.
Shipping Options:
- Incoterms: EXW, FOB, CIF, DDP
- Sea, air, and land freight coordination
- Cold chain support (if needed for specific orders)
- Professional packing and palletizing for bulk orders
- Full customs and documentation assistance
We deliver to over 30 countries, backed by timely dispatch, accurate documentation, and responsive customer service.
Minimum Order Quantity and Lead Time
| Form | Minimum Order Quantity | Lead Time |
|---|---|---|
| Valsartan + HCTZ Tablets | 100,000 tablets | 20–25 working days |
| Custom Strength Formulations | 50,000 tablets | 25–30 working days |
| Sample / Pilot Batches | 20–50 strips | 7–10 working days |
Lead time may vary based on artwork approval, custom packaging, and regulatory documentation requirements.
Global Market Opportunity
The fixed-dose combination of Valsartan + Hydrochlorothiazide is recognized worldwide for its clinical efficacy, cost-effectiveness, and once-daily convenience. Demand is growing due to:
- Increased incidence of lifestyle-related hypertension
- Government programs promoting affordable cardiovascular therapy
- WHO recommendations for combination antihypertensive therapy
- Preference for fixed-dose regimens to enhance compliance
It is included in several national essential medicine lists, making it highly relevant for public health tenders and private market expansion.
Ideal Clients and Business Models
Our manufacturing solutions are best suited for:
- Generic pharmaceutical companies expanding into cardiovascular therapy
- Hospital procurement and public health institutions
- Exporters to Africa, Asia, LATAM, CIS, and Middle East
- Government tender suppliers
- E-commerce platforms and private-label healthcare brands
We offer both white-label and custom-branded solutions, tailored to your regulatory, clinical, and commercial goals.
Why Choose BluepillExpress?
- WHO-GMP certified infrastructure
- Extensive experience in fixed-dose combination manufacturing
- Competitive pricing and high-volume production capacity
- Regulatory expertise and dossier-ready support
- Flexibility in formulation, packaging, and market adaptation
- Proven track record across 30+ international markets
Partnering with BluepillExpress ensures access to affordable, reliable, and globally compliant antihypertensive products designed for scale and impact.
Conclusion
The combination of Valsartan + Hydrochlorothiazide offers a powerful, evidence-based solution for blood pressure control in a wide spectrum of patients. As cardiovascular risk continues to rise worldwide, fixed-dose therapies like this will be central to managing public health outcomes efficiently.
With BluepillExpress as your third-party manufacturing partner, you gain access to world-class production, regulatory expertise, and scalable business models, enabling your brand to lead in the cardiovascular segment with confidence.
