Nifedipine Extended Release

Cardiovascular disease remains one of the leading causes of death globally, with hypertension and angina pectoris accounting for a significant portion of related morbidity and mortality. Effective long-term management of blood pressure and cardiac workload is crucial to reduce the risk of heart attacks, strokes, and heart failure. One of the most widely used and well-tolerated medications in this therapeutic class is Nifedipine, especially in its Extended Release (ER) formulation.

BluepillExpress, a WHO-GMP certified third-party manufacturing partner, offers Nifedipine Extended Release tablets designed for sustained therapeutic effect, smooth blood pressure control, and improved compliance. Our manufacturing services cater to pharmaceutical companies, hospitals, and institutional buyers across global markets with export-ready formulations, flexible production models, and full regulatory support.

What is Nifedipine Extended Release?

Nifedipine is a calcium channel blocker (CCB) belonging to the dihydropyridine class. It works by inhibiting the influx of calcium ions into vascular smooth muscle and myocardial cells during depolarization, leading to vasodilation and reduced peripheral vascular resistance. This action results in lowered blood pressure, reduced myocardial oxygen demand, and improved blood flow to the heart.

The Extended Release formulation of Nifedipine is specifically designed to maintain consistent plasma concentrations over 24 hours, thereby ensuring steady blood pressure control, reduced dosing frequency, and improved tolerability compared to immediate-release versions.

Therapeutic Class

• Calcium Channel Blocker (Dihydropyridine)
• Antihypertensive
• Anti-anginal Agent

Key Benefits of Nifedipine Extended Release

1. Effective 24-Hour Blood Pressure Control

Nifedipine ER provides once-daily dosing with steady-state drug levels, avoiding peaks and troughs that may occur with conventional formulations.

2. Reduces Risk of Cardiovascular Events

By lowering systolic and diastolic blood pressure, it helps reduce the risk of stroke, myocardial infarction, and left ventricular hypertrophy.

3. Relieves Chronic Stable Angina

The vasodilatory action enhances oxygen supply to cardiac muscles, reducing the frequency and severity of angina episodes.

4. Improved Patient Compliance

Extended-release formulation minimizes side effects like reflex tachycardia and promotes better adherence to treatment protocols due to once-daily dosing.

5. Suitable for Long-Term Therapy

Its pharmacokinetic profile supports use in chronic hypertensive patients and those requiring long-term anti-anginal maintenance therapy.

Indications

Nifedipine Extended Release is indicated for:

• Management of essential hypertension (primary high blood pressure)
• Treatment of chronic stable angina pectoris
• Vasospastic (Prinzmetal’s) angina
• Adjunct therapy in patients with cardiovascular risk factors
• Use in combination with other antihypertensive agents (e.g., beta-blockers, ACE inhibitors, or diuretics)

It is recommended for adult patients and should be prescribed and monitored by a licensed healthcare professional.

Composition and Available Strengths

BluepillExpress manufactures Nifedipine Extended Release tablets in the following strengths:

• Nifedipine ER 20 mg
• Nifedipine ER 30 mg
• Nifedipine ER 60 mg
• Nifedipine ER 90 mg (available upon special request)

Each tablet is:

• Designed for once-daily administration
• Manufactured with osmotic-controlled release or matrix technology, depending on partner preference
• Compliant with USP/BP/EP standards
• Film-coated for ease of swallowing and protection against photodegradation

Dosage and Administration

General Dosage Guidelines:

• Hypertension:
  Initial dose: 30–60 mg once daily
  Maintenance: 30–90 mg once daily depending on response
• Angina:
  30–60 mg once daily
  Titrated as per physician’s evaluation and therapeutic goals

The tablets must be swallowed whole and not crushed or chewed, as this may interfere with the controlled-release mechanism. Dosing adjustments may be required in elderly patients, those with hepatic impairment, or when used in combination with other cardiovascular agents.

Pharmacokinetics

• Absorption: Well absorbed orally; extended-release formulation ensures consistent plasma levels
• Bioavailability: Approximately 45–70%
• Half-life: 7–9 hours (extended-release formulation provides effective 24-hour coverage)
• Metabolism: Extensively metabolized in the liver by CYP3A4
• Excretion: Primarily via urine as inactive metabolites

Manufacturing Capabilities

At BluepillExpress, we offer robust third-party manufacturing services for Nifedipine ER with:

• High-volume compression lines for tablet production
• Use of osmotic pump, hydrophilic matrix, or coated reservoir systems for extended release
• Controlled granulation and coating environments to ensure batch uniformity
• Cleanroom manufacturing with HVAC-controlled facilities
• Automatic blister packing and bottle filling lines

We produce according to customized batch sizes, branding, and packaging requirements, supporting both high-volume domestic demand and export shipment orders.

Packaging and Presentation

We provide multiple packaging options designed for international regulatory compliance, patient convenience, and brand identity.

Primary Packaging:

• Blister packs (Alu-Alu or PVC)
• HDPE bottles with moisture-absorbing desiccants
• Tamper-evident packaging for retail and hospital supply

Secondary Packaging:

• Custom-designed mono cartons with brand labeling
• Multilingual artwork available for global markets
• Serialized labeling, QR codes, and barcoding
• Instruction leaflets included as per market-specific regulatory standards

Quality and Compliance

Our facility is fully compliant with international manufacturing guidelines, supported by extensive quality assurance and validation protocols.

Certifications:

• WHO-GMP
• ISO 22000:2018
• FSSAI (India)
• FDA (India) Manufacturing License
• Support for GCC, Africa, Latin America, and Southeast Asia registration

Quality Control Parameters:

• Assay and content uniformity
• Dissolution profile matching innovator brands
• Related substances and impurity profiling
• Tablet hardness, friability, and stability
• Real-time and accelerated stability testing under ICH guidelines

Each batch is accompanied by a Certificate of Analysis (CoA) and is subject to batch-to-batch consistency evaluations.

Regulatory Support and Documentation

We provide comprehensive documentation and regulatory assistance for registration in domestic and export markets.

Documents Include:

• Certificate of Analysis (CoA)
• Certificate of Pharmaceutical Product (COPP)
• Certificate of Origin (COO)
• Free Sale Certificate (FSC)
• Product Dossier (CTD / ACTD format)
• MSDS (Material Safety Data Sheet)
• Marketing Authorization and Manufacturing License copies
• Product labeling and promotional content support

Export and Logistics

BluepillExpress supports full-scale logistics and export services, including:

• EXW, FOB, CIF, and DDP shipping terms
• Dedicated coordination with customs and freight forwarders
• International air and sea freight options
• Custom palletizing, shrink-wrapping, and bulk packing
• Support for tender-based supply and cold chain management (if needed)

Our export team has experience shipping to over 30 countries, including regulated and semi-regulated markets.

Minimum Order Quantity and Lead Time

Product Form	Minimum Order Quantity	Lead Time
Nifedipine ER Tablets	100,000 tablets	20–25 working days
Custom Strength / SR	50,000 tablets	25–30 working days
Sample Development	20–50 samples	7–10 working days

Lead times may vary based on artwork approval, packaging materials, and specific regulatory needs.

Market Demand and Opportunity

The global demand for Nifedipine ER is consistently strong due to:

• Increasing prevalence of hypertension and cardiovascular disease
• Global focus on chronic disease management
• Demand for once-daily, compliance-friendly medications
• Use in combination therapy alongside beta-blockers, diuretics, or ACE inhibitors
• Low cost, high efficacy solution for government tenders and public health programs

Nifedipine Extended Release remains a first-line treatment across public and private healthcare sectors.

Ideal Partners

Our Nifedipine ER third-party manufacturing services are best suited for:

• Pharmaceutical companies expanding cardiovascular portfolios
• Private-label OTC and prescription brands
• Government tender suppliers
• Hospital procurement organizations
• Exporters targeting Africa, Asia, Middle East, and LATAM
• E-commerce pharmacy startups and generic distributors

We support both branded generic and contract manufacturing models with flexible business terms.

Why Choose BluepillExpress?

• WHO-GMP certified manufacturing with full transparency
• Scalable production and timely delivery
• Competitive pricing for high-volume orders
• Complete formulation-to-market service
• Regulatory documentation and dossier support
• Strategic export partnerships across 5 continents

Whether you’re looking to expand your cardiovascular therapeutic line, participate in government contracts, or launch a global generic brand, BluepillExpress offers the tools, compliance, and trust you need to succeed.

Conclusion

Nifedipine Extended Release is a cornerstone therapy in cardiovascular medicine, offering effective 24-hour control of blood pressure and angina symptoms. With the increasing global burden of hypertension and heart disease, reliable, high-quality Nifedipine ER formulations are in greater demand than ever.

BluepillExpress is your dependable third-party manufacturing partner, committed to delivering quality, compliance, and global reach—helping you provide essential cardiac care to patients worldwide.