Nifedipine

Nifedipine is a well-established calcium channel blocker used extensively in the management of hypertension and angina pectoris. It belongs to the dihydropyridine class of calcium channel antagonists, offering effective vasodilation and smooth muscle relaxation, resulting in reduced blood pressure and improved oxygen supply to the heart. Its efficacy, safety profile, and wide therapeutic usage have made it a staple in cardiovascular pharmacotherapy.

At BluepillExpress, we specialize in the third-party manufacturing of Nifedipine tablets and extended-release formulations with the highest quality standards, tailored to global regulatory requirements. Our manufacturing services are comprehensive, including formulation development, private labeling, quality assurance, packaging, and international logistics.

About BluepillExpress

BluepillExpress is a WHO-GMP and ISO 9001:2015 certified pharmaceutical manufacturing company based in India, serving clients across more than 50 countries worldwide. Our robust infrastructure and manufacturing excellence empower pharmaceutical companies, hospitals, distributors, and government bodies to launch and expand their product portfolios without the need to invest in in-house production facilities.

We offer custom formulation and scalable manufacturing solutions for a wide range of therapeutic categories, including cardiovascular drugs, antibiotics, antidiabetics, nutraceuticals, and more. Our flexible approach supports both emerging brands and established multinational companies.

Pharmacological Classification

• Drug Name: Nifedipine
• Therapeutic Class: Calcium Channel Blocker (Dihydropyridine Class)
• Primary Indications: Hypertension, Chronic Stable Angina, Vasospastic Angina
• Route of Administration: Oral

Mechanism of Action

Nifedipine inhibits the influx of calcium ions through the L-type calcium channels of vascular smooth muscle and myocardial cells. This results in:

• Vasodilation of peripheral arteries, reducing systemic vascular resistance and lowering blood pressure
• Reduced myocardial oxygen demand by decreasing afterload
• Increased coronary blood flow in patients with angina

Nifedipine does not significantly affect cardiac conduction or contractility, making it suitable for a wide range of cardiovascular patients.

Clinical Indications

Nifedipine is prescribed for:

• Hypertension (mild to moderate)
• Chronic stable angina
• Vasospastic (Prinzmetal’s) angina
• Raynaud’s phenomenon (off-label)
• Preterm labor (off-label in obstetric use)

It is available in immediate-release and extended-release (controlled-release) formulations to suit different therapeutic needs.

Dosage Forms Offered by BluepillExpress

We offer third-party manufacturing of Nifedipine in the following dosage forms:

1. Immediate-Release Tablets

• Nifedipine 10 mg
• Nifedipine 20 mg
• Typically administered 3–4 times daily for angina or blood pressure control
• Available in blister and bottle packs

2. Extended-Release Tablets (Sustained Release)

• Nifedipine 30 mg SR
• Nifedipine 60 mg SR
• Once or twice-daily dosing for sustained blood pressure control
• Designed for steady drug release over 12 to 24 hours
• Film-coated for better gastric tolerance

Dosage forms can be customized based on the client’s target market regulations and specific release profile requirements.

Manufacturing Capabilities and Infrastructure

Our manufacturing units are designed for high-volume production of solid oral dosage forms, with seamless integration of quality, safety, and scalability.

Key Features:

• Separate production areas for immediate and extended-release tablets
• Fully automated granulation, compression, coating, and packaging lines
• Dedicated air-handling systems to prevent cross-contamination
• On-site R&D laboratory for formulation customization
• WHO-GMP compliant cleanroom environment
• Skilled and experienced production team for handling specialized formulations like SR tablets

Our monthly production capacity enables us to fulfill bulk orders and long-term supply contracts efficiently.

Quality Control and Assurance

At BluepillExpress, quality is the foundation of everything we do. Our Quality Assurance (QA) and Quality Control (QC) departments strictly adhere to international standards including WHO-GMP, ICH, and national pharmacopeias (IP, BP, USP).

Key Quality Practices:

• API and excipient identification and purity testing
• In-process checks for tablet hardness, weight variation, friability, and disintegration
• Assay testing using validated HPLC methods
• Dissolution studies for both IR and SR forms
• Microbial limit testing (when required)
• Stability testing under ICH guidelines (real-time and accelerated)

All manufactured batches are accompanied by:

• Certificate of Analysis (COA)
• Batch Manufacturing Records (BMR)
• Validation and calibration documents
• Regulatory compliance certificates

Packaging and Labeling Services

We offer customized packaging and labeling solutions for all Nifedipine dosage forms:

Tablet Packaging Options:

• Alu-Alu or PVC-Alu blister packs
• HDPE or PET bottles
• Custom carton box printing with multilingual inserts
• Foil printing with batch and expiry details

We support:

• Private-label packaging with custom branding
• Regulatory-compliant label design for various countries
• Inclusion of product literature and usage instructions

Our packaging ensures product stability, traceability, and patient convenience while meeting market-specific branding preferences.

Regulatory Documentation and Export Support

BluepillExpress offers full regulatory and export documentation support to simplify international market entry. Our team provides:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Free Sale Certificate
• Certificate of Origin
• Certificate of Analysis (COA)
• Stability data (on request)
• Dossier preparation in CTD/ACTD format
• MSDS (Material Safety Data Sheet)

We assist clients with:

• Product registration in their country
• Compliance with regulatory authorities (FDA, EMA, TGA, SFDA, NDA, etc.)
• Export documentation and customs clearance

Private Label and Contract Manufacturing Process

Our six-step third-party manufacturing process ensures efficiency and transparency from inquiry to dispatch:

1. Requirement Analysis
   Client provides details about formulation, strength, dosage form, packaging, and regulatory needs.
2. Quotation & Agreement
   We send a detailed commercial proposal with pricing, MOQ, timelines, and terms.
3. Product Development
   Pilot batches or samples are prepared and shared for client approval.
4. Manufacturing & Quality Testing
   Bulk production is carried out under GMP conditions, followed by in-depth quality testing.
5. Packaging & Labeling
   Products are packed with customized labels, leaflets, and branding.
6. Dispatch & Documentation
   Finished goods are dispatched with all regulatory and export documents for seamless importation.

Client Segments and Target Markets

Our Nifedipine third-party manufacturing services are ideal for:

• Generic pharmaceutical brands
• Cardiovascular medicine suppliers
• Hospital procurement agencies
• Retail pharmacy networks
• Public health institutions
• Government tender providers
• International pharmaceutical distributors

We currently export to:

• Africa (Nigeria, Kenya, Ethiopia, Ghana, Tanzania)
• Southeast Asia (Vietnam, Myanmar, Philippines)
• CIS (Kazakhstan, Uzbekistan, Kyrgyzstan)
• Middle East (UAE, Iraq, Yemen, Jordan)
• Latin America and Caribbean markets

Sustainability and Ethical Manufacturing

As a responsible pharmaceutical manufacturer, BluepillExpress is committed to sustainable and ethical operations:

• Wastewater treatment and effluent management systems
• Energy-saving machinery and green packaging
• No child labor or unethical employment practices
• Commitment to recyclable and biodegradable materials
• Community outreach and CSR programs in healthcare access

Our commitment to sustainable manufacturing strengthens our long-term partnerships and supports global health goals.

Why Partner with BluepillExpress?

• WHO-GMP certified production units
• Flexible batch sizes to support both startups and large distributors
• Regulatory expertise for global market registration
• Full confidentiality and private-label protection
• On-time delivery and post-sale support
• Affordable pricing without compromise on quality

Whether you are launching a new Nifedipine product or expanding your cardiovascular range, BluepillExpress is equipped to meet your every need with excellence.

Conclusion

Nifedipine continues to be a critical therapeutic agent in the management of cardiovascular diseases due to its potent antihypertensive and anti-anginal effects. As global demand for safe, affordable cardiovascular drugs rises, third-party manufacturing of Nifedipine offers a strategic opportunity for pharmaceutical businesses to grow and reach new markets.

BluepillExpress provides world-class manufacturing solutions that combine innovation, compliance, and market readiness. From formulation to final packaging, we ensure a seamless experience for our clients looking to deliver trusted Nifedipine products under their brand.