Valsartan

Valsartan is a selective angiotensin II receptor blocker (ARB) widely used for the management of hypertension (high blood pressure), heart failure, and post-myocardial infarction care. By blocking the vasoconstrictive and aldosterone-secreting effects of angiotensin II, Valsartan promotes vasodilation and reduces blood pressure, thereby offering protective benefits to the cardiovascular and renal systems.

As global cardiovascular disease rates rise, the demand for safe, effective, and affordable antihypertensive therapy like Valsartan continues to increase. At BluepillExpress, we specialize in third-party manufacturing of Valsartan formulations, providing fully compliant and high-quality solutions for brands, pharmaceutical marketers, and international distributors.

With modern WHO-GMP-certified facilities, validated processes, and regulatory expertise, we support clients in launching and distributing Valsartan products in both regulated and semi-regulated markets.

Therapeutic Indications

Valsartan is indicated for the treatment of several cardiovascular and renal conditions:

• Essential Hypertension – First-line therapy in adults and pediatric patients
• Congestive Heart Failure (CHF) – To reduce mortality and hospitalization
• Post-Myocardial Infarction (MI) – To improve survival following heart attack
• Left Ventricular Dysfunction
• Chronic Kidney Disease (CKD) – To reduce proteinuria and protect renal function (off-label)

Due to its favorable safety profile and minimal adverse effects, Valsartan is widely prescribed as a monotherapy or in combination with other agents such as diuretics or calcium channel blockers.

Mechanism of Action

Valsartan selectively inhibits the angiotensin II type 1 (AT1) receptor, preventing angiotensin II from binding and causing vasoconstriction, aldosterone release, and sodium retention. As a result:

• Peripheral resistance is reduced
• Sodium and water excretion is increased
• Cardiac workload and afterload decrease

Unlike ACE inhibitors, Valsartan does not affect the bradykinin pathway, minimizing the incidence of cough and angioedema. This makes it a preferred alternative for patients intolerant to ACE inhibitors.

Available Dosage Forms by BluepillExpress

At BluepillExpress, we offer a wide range of Valsartan dosage strengths and customized formulations to suit diverse therapeutic requirements:

1. Valsartan Tablets

• 40 mg
• 80 mg
• 160 mg
• 320 mg

2. Valsartan Combination Tablets (Available upon request)

• Valsartan + Hydrochlorothiazide (HCTZ)
• Valsartan + Amlodipine
• Triple combinations (e.g., Valsartan + Amlodipine + HCTZ)

All tablets are formulated in film-coated, scored, or extended-release formats based on client and regulatory needs.

Manufacturing Excellence at BluepillExpress

As a leading third-party pharmaceutical manufacturer, BluepillExpress combines state-of-the-art manufacturing facilities, stringent quality standards, and dedicated customer support to deliver high-performance cardiovascular medications.

Key Capabilities:

• WHO-GMP and ISO 9001:2015 certified plants
• High-capacity production lines for tablets and combination drugs
• Air-controlled cleanrooms for contamination-free production
• High-speed compression and blister/strip packing machinery
• In-house analytical and microbiological labs
• Regulatory-compliant documentation and validation protocols

Each batch of Valsartan undergoes standardized manufacturing protocols to ensure uniformity, potency, and bioavailability.

Quality Control and Assurance

Our Quality Assurance (QA) and Quality Control (QC) systems are built to comply with international pharmacopeial standards including IP, BP, USP, and EP.

Every Valsartan batch is subjected to:

• Raw material and excipient verification
• Active ingredient assay and identity testing
• Dissolution and disintegration profiling
• Content uniformity analysis
• Microbial limit testing
• Stability testing (real-time and accelerated)
• Impurity profiling and heavy metals testing

We maintain complete traceability and auditability for each production cycle to support compliance and regulatory inspections.

Customization and Private Label Manufacturing

BluepillExpress supports full-spectrum private label manufacturing for clients seeking to market Valsartan under their own brand. We provide:

• Custom formulation development based on bioavailability goals
• Packaging customization (blister, strip, bottle, unit dose)
• Brand design and artwork creation
• Multilingual packaging for export
• E-commerce and OTC-compatible packaging (on request)

Our dedicated design and regulatory team works closely with clients to create brand-compliant products that meet all country-specific labeling norms.

Regulatory Documentation Support

We provide a complete set of documents to facilitate product registration and regulatory submissions in both regulated and emerging markets. This includes:

• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Batch Manufacturing Records (BMR)
• Master Formula Record (MFR)
• Drug Master File (DMF) – on request
• Dossiers in CTD/eCTD/ACTD format
• Product Stability Data
• Material Safety Data Sheet (MSDS)
• Method of Analysis (MOA) and validation protocols

Our regulatory affairs team supports submission filing, label compliance, and pharmacovigilance documentation, ensuring a smooth registration process for all clients.

Export Readiness and Global Supply Chain

BluepillExpress is a trusted global exporter of cardiovascular formulations like Valsartan, offering timely deliveries, compliance, and documentation support for international markets. We currently serve clients across:

• Africa (Kenya, Nigeria, Ethiopia, South Africa, Ghana)
• Middle East (UAE, Saudi Arabia, Oman, Iraq)
• Southeast Asia (Vietnam, Cambodia, Myanmar, Philippines)
• CIS Countries (Uzbekistan, Georgia, Kazakhstan)
• Latin America (Bolivia, Peru, Honduras, Dominican Republic)

Our export capabilities include:

• Flexible shipping terms (EXW, FOB, CIF)
• Multilingual labeling and inserts
• Country-specific documentation and registration dossiers
• Cold chain and ambient storage conditions
• Regulatory inspection readiness

We support tenders, institutional supply contracts, and commercial retail orders with equal precision and commitment.

Research and Development

Our R&D division focuses on formulation innovation, combination development, and process optimization for Valsartan and its derivatives. Services include:

• Development of extended-release formulations
• Bioequivalence studies (BE) and pharmacokinetic profiling
• Triple-combination antihypertensives
• Stability optimization for hot and humid climates
• Taste-masking for pediatric and geriatric dosage forms
• Custom dissolution profiles to meet regional pharmacopoeial requirements

We also support technology transfer, pilot batches, and scale-up validations for new product development partners.

Shelf Life and Storage

• Standard shelf life: 24 to 36 months
• Storage conditions: Store below 30°C, protect from moisture and sunlight
• Packaging: Designed to preserve tablet integrity in hot and humid zones (Zone III and IV)

All batches undergo stability studies in accordance with ICH guidelines to ensure quality retention throughout the product’s lifecycle.

Environmental and Ethical Compliance

At BluepillExpress, we uphold the principles of environmental sustainability, ethical business conduct, and workplace safety:

• Effluent treatment and pollution control systems
• Waste segregation and responsible disposal
• Non-toxic, eco-safe excipients and solvents
• Regular GMP training and occupational safety programs
• CSR and local community health initiatives

Our commitment to eco-conscious pharmaceutical manufacturing reflects in every stage of our operations.

Conclusion

Valsartan continues to play a central role in managing hypertension, heart failure, and cardiovascular protection across all age groups. With its proven clinical efficacy, strong safety profile, and compatibility with multiple drug classes, Valsartan remains a mainstay in cardiovascular medicine.

At BluepillExpress, we provide trusted, scalable, and globally compliant third-party manufacturing solutions for Valsartan and its combinations. Our advanced infrastructure, regulatory strength, and client-centric services make us a reliable partner for companies seeking to expand their presence in cardiovascular therapeutics.