Valsartan + Hydrochlorothiazide + Amlodipine Besilate

The fixed-dose combination of Valsartan, Hydrochlorothiazide, and Amlodipine Besilate is a powerful triple-drug therapy used for the effective management of hypertension (high blood pressure). This synergistic combination addresses multiple physiological pathways that contribute to elevated blood pressure, offering better control for patients with moderate to severe or treatment-resistant hypertension.

At BluepillExpress, we provide end-to-end third-party manufacturing services for this triple-combination antihypertensive medication. With a WHO-GMP and ISO-certified infrastructure, our manufacturing capabilities cater to pharmaceutical companies, hospitals, and health distributors across more than 50 countries, enabling them to deliver compliant, high-quality cardiovascular medications under their own brand name.

About BluepillExpress

BluepillExpress is a globally recognized pharmaceutical manufacturing and export company, offering contract manufacturing and private-label services across diverse therapeutic categories. With over a decade of expertise, state-of-the-art manufacturing facilities, and regulatory competence, we help our partners bring superior-quality, affordable medicines to the market.

We provide:

• High-quality drug formulations compliant with international standards
• Scalable production with flexible batch sizes
• Regulatory documentation and export assistance
• Custom packaging and private-label support

We are fully certified by WHO-GMP, ISO 9001:2015, and operate according to cGMP guidelines to ensure the safety, efficacy, and global acceptability of every batch.

Pharmacological Classification

• Valsartan – Angiotensin II Receptor Blocker (ARB)
• Hydrochlorothiazide (HCTZ) – Thiazide Diuretic
• Amlodipine Besilate – Dihydropyridine Calcium Channel Blocker

Therapeutic Class: Triple antihypertensive combination
Primary Use: Management of essential hypertension, especially in patients unresponsive to monotherapy or dual therapy

Mechanism of Action

This triple-drug formulation targets different mechanisms that cause high blood pressure:

• Valsartan selectively blocks the angiotensin II type-1 receptor, inhibiting vasoconstriction and aldosterone-mediated fluid retention.
• Hydrochlorothiazide increases sodium and water excretion, reducing plasma volume and cardiac output.
• Amlodipine Besilate inhibits calcium influx in vascular smooth muscle, leading to vasodilation and reduced peripheral resistance.

Together, the combination ensures synergistic blood pressure reduction, minimal side effects, and better adherence compared to separate or dual-drug regimens.

Clinical Indications

This combination therapy is prescribed in:

• Patients with moderate to severe hypertension unresponsive to dual therapy
• Patients at high cardiovascular risk due to persistent elevated blood pressure
• Individuals with left ventricular hypertrophy
• Those with diabetes or renal impairment (under medical supervision)
• Patients requiring long-term blood pressure maintenance therapy

Dosage Forms Offered by BluepillExpress

We manufacture Valsartan + Hydrochlorothiazide + Amlodipine Besilate in various standard and customizable dosages to match global formulary requirements:

1. Oral Film-Coated Tablets

Available standard strengths include:

• Valsartan 160 mg + HCTZ 12.5 mg + Amlodipine Besilate 5 mg
• Valsartan 160 mg + HCTZ 25 mg + Amlodipine Besilate 5 mg
• Valsartan 80 mg + HCTZ 12.5 mg + Amlodipine Besilate 5 mg
• Custom strengths based on client demand and market authorization

Each tablet is manufactured with bioavailability-optimized granulation, film coating for gastric protection, and proper excipient selection to ensure stability.

Packaging options include blister packs, strip packs, and HDPE bottle formats with customized outer cartons.

Manufacturing Infrastructure and Capabilities

Our WHO-GMP-approved manufacturing facility is equipped to produce high-quality cardiovascular tablets at scale while meeting the most stringent global standards.

Features include:

• Fully automated granulation, compression, and coating machinery
• Separate areas for hormonal and non-hormonal drug processing
• Controlled environmental zones with HEPA filters and AHU systems
• Dust-free packaging lines and track-and-trace capabilities
• In-house utilities including purified water and HVAC systems
• High-precision tablet tooling and continuous process monitoring

We follow batch-wise documentation, cleaning validation, and process validation protocols to ensure traceability and reproducibility.

Quality Control and Assurance

BluepillExpress maintains strict QA/QC procedures throughout the manufacturing lifecycle:

• Raw material testing for identity, potency, and purity
• In-process quality checks for uniformity, weight variation, hardness, disintegration
• Final product testing for assay, dissolution, and stability (per ICH)
• Microbial testing (when required)
• Tablet coating integrity and packaging seal analysis

Each batch is delivered with:

• Certificate of Analysis (COA)
• Batch Manufacturing Record (BMR)
• Product specification sheet
• Analytical method validation (available on request)

We also provide real-time and accelerated stability data for product registration purposes.

Packaging and Labeling Services

We offer a wide variety of customizable packaging formats to suit your brand and local market regulations:

Tablet Packaging Options:

• Blister strips: PVC/Alu, Alu/Alu with 10×10 or 10x1x10 formats
• Bottles: HDPE or PET with child-resistant caps
• Outer cartons: Multicolor, multilanguage with optional inserts

Labeling Services:

• Private labeling with your brand identity
• Multilingual labeling (French, Arabic, Spanish, etc.)
• Compliance with FDA, EMA, GCC, African, and ASEAN market norms

Our design team can assist in developing regulatory-compliant and visually impactful product packaging to enhance brand recognition and retail appeal.

Regulatory and Export Documentation

We provide complete technical and export documentation to support your market entry and registration processes:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate
• Certificate of Analysis (COA)
• Certificate of Origin
• Stability data (available upon request)
• MSDS (Material Safety Data Sheet)
• Product dossiers in CTD or ACTD format

Our regulatory team works closely with clients to prepare documentation tailored to the specific requirements of countries across Africa, Asia, Europe, CIS, and the Middle East.

Private Label and Third-Party Manufacturing Services

Our third-party manufacturing model enables clients to launch and market their own branded triple combination antihypertensive without the complexities of production.

Our services include:

• Sourcing of quality-assured active ingredients
• Formulation and tablet design optimization
• Product registration support
• Packaging and artwork development
• Regulatory assistance and dossier preparation
• Global dispatch and logistics coordination

We support both low-MOQ startups and large-volume distributors, offering scalable manufacturing tailored to your business stage and target markets.

Markets We Serve

BluepillExpress serves a wide variety of client segments and geographies, including:

Client Types:

• Generic pharmaceutical brands
• Cardiology-focused product companies
• Government healthcare departments
• Tender procurement authorities
• Retail pharmacy chains
• Telemedicine and online platforms
• Institutional buyers and hospital chains

Target Markets:

• Africa (Nigeria, Kenya, Ethiopia, Ghana, Tanzania)
• Middle East (UAE, Iraq, Saudi Arabia, Yemen)
• Asia (Vietnam, Myanmar, Cambodia, Philippines)
• CIS Countries (Uzbekistan, Kazakhstan, Armenia)
• Latin America (Colombia, Dominican Republic, Peru)

We assist in product registration, tender bidding, and long-term contract fulfillment for public and private sector clients.

Sustainability and Compliance Practices

At BluepillExpress, our manufacturing practices are guided by sustainability, ethics, and compliance:

• Environmentally responsible effluent treatment systems
• Minimal waste generation and energy-efficient production lines
• Recyclable, eco-friendly packaging solutions
• No child labor, fair labor practices, and gender inclusivity
• Ethical sourcing of APIs from certified suppliers

We align with UN Sustainable Development Goals (SDGs), contributing to health, environmental responsibility, and global wellness.

Steps to Partner with BluepillExpress

1. Requirement Discussion
   Share your dosage strength, formulation type, packaging, and registration needs.
2. Quotation and Technical Review
   Receive a detailed quote and initiate documentation for third-party manufacturing.
3. Sample Approval and Pilot Batch (if needed)
   We produce a trial batch/sample for client and regulatory approval.
4. Bulk Production and QA Checks
   Products are manufactured under validated conditions and undergo full quality testing.
5. Labeling, Packaging & Dispatch
   Customized packaging and shipping with supporting export and regulatory documentation.
6. After-Sales Support
   Ongoing coordination for reorders, variations, or market feedback integration.

Conclusion

Valsartan + Hydrochlorothiazide + Amlodipine Besilate offers comprehensive, long-acting blood pressure control through three synergistic mechanisms. As hypertension continues to be a global health burden, this fixed-dose combination is an essential formulation in any cardiovascular medicine portfolio.

BluepillExpress is your ideal partner for manufacturing this formulation under your own brand name, backed by quality, compliance, flexibility, and a strong global distribution network. With tailored third-party solutions and end-to-end regulatory support, we help you confidently bring this triple therapy to your market.