Ranitidine

Ranitidine is a histamine H2-receptor antagonist commonly used to reduce the production of stomach acid. For decades, it has been prescribed globally for treating conditions such as peptic ulcers, gastroesophageal reflux disease (GERD), acid indigestion, heartburn, and Zollinger-Ellison syndrome. Ranitidine became a first-line therapy in managing acid-related disorders due to its excellent efficacy, tolerability, and broad applicability.

At BluepillExpress, we offer WHO-GMP-compliant third-party manufacturing of Ranitidine in various oral dosage forms. Our modern pharmaceutical infrastructure supports large-scale production with stringent quality control measures, making us the preferred manufacturing partner for pharmaceutical distributors, hospital suppliers, and international NGOs.

We are committed to manufacturing Ranitidine formulations that are safe, stable, and effective, while supporting our partners with full regulatory documentation, private-label packaging, and export services to over 50 countries.

About BluepillExpress

BluepillExpress is a global third-party pharmaceutical manufacturer headquartered in India, providing contract manufacturing, bulk supply, and private-label production for a wide range of APIs and finished formulations. We are known for:

• State-of-the-art WHO-GMP certified manufacturing facilities
• Compliance with ISO 9001:2015, Schedule M, and global export norms
• Specialization in gastrointestinal, cardiovascular, and anti-infective formulations
• Custom branding and packaging solutions
• Complete regulatory assistance and product registration support

Our mission is to offer high-quality, affordable medications that meet international standards and help improve global health outcomes.

Pharmacological Overview

• Generic Name: Ranitidine Hydrochloride
• Pharmacological Class: Histamine H2 Receptor Antagonist
• Therapeutic Class: Anti-ulcer, Acid Suppressant
• Primary Indication: Reduces stomach acid production
• Route of Administration: Oral (tablets, syrup), Injectable (by request)

Mechanism of Action

Ranitidine works by selectively blocking histamine H2 receptors in the gastric parietal cells. This action inhibits basal and stimulated gastric acid secretion, leading to:

• Decreased gastric volume
• Reduced hydrogen ion concentration
• Relief from acid-related symptoms such as heartburn and discomfort

Ranitidine has a relatively fast onset of action and a duration that allows for once or twice daily dosing, making it convenient for both acute and chronic use.

Indications and Uses

Ranitidine is used in the treatment of multiple gastrointestinal conditions, including:

• Duodenal and gastric ulcers
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome
• Erosive esophagitis
• Dyspepsia (indigestion)
• Stress-induced gastric ulcers
• NSAID-associated gastric irritation
• Pediatric reflux and ulcer management (syrup formulation)

Though usage has declined in some markets following regulatory scrutiny, Ranitidine remains widely prescribed and distributed in many developing regions due to its affordability and effectiveness.

Dosage Forms and Strengths Manufactured by BluepillExpress

BluepillExpress offers Ranitidine in the following standard dosage forms:

1. Ranitidine Tablets

• 150 mg and 300 mg strengths
• Film-coated or uncoated options
• Blister packs (10×10, 10x1x10) or bulk bottles
• IP, BP, USP standards available

2. Ranitidine Oral Syrup

• 75 mg/5 ml or 150 mg/10 ml
• Palatable, flavored syrup (orange/vanilla)
• 100 ml and 200 ml HDPE or glass bottles

3. Ranitidine Injection (on request)

• For hospital and emergency use
• 25 mg/ml in 2 ml and 5 ml ampoules

We also offer custom formulation development depending on partner requirements and regulatory approval status in target countries.

Manufacturing Capabilities

Our state-of-the-art facilities are capable of handling high-volume production while maintaining excellent batch consistency and GMP compliance.

Key Capabilities:

• Automated granulation, compression, and coating equipment
• Dedicated lines for syrups, tablets, and sterile injectable manufacturing
• Climate-controlled production zones (HVAC Class 100,000)
• Integrated SCADA and PLC-controlled systems for process validation
• Cleanroom environments for contamination-free production
• Real-time monitoring of environmental and process parameters

Our tablet and syrup manufacturing facilities are validated to produce both immediate-release and controlled-release oral dosage forms.

Quality Control and Assurance

BluepillExpress follows a robust quality management system that encompasses every stage of production from raw material sourcing to finished product packaging.

In-House QC Testing Includes:

• Raw material identity and purity checks
• Tablet hardness, friability, disintegration, and dissolution tests
• Syrup viscosity, pH, flavor consistency, and microbial load
• Content assay and uniformity using HPLC or UV spectrophotometry
• Stability testing (real-time and accelerated per ICH guidelines)
• Microbial and endotoxin testing for injectables

Each batch is accompanied by:

• Certificate of Analysis (COA)
• Batch Manufacturing Record (BMR)
• Stability Data
• MSDS and Specifications Sheet

Our QA department ensures all processes are fully documented and compliant with global pharmacopoeial standards (IP/BP/USP).

Packaging and Labeling Services

We provide customizable packaging solutions that cater to retail, institutional, and tender-based distribution.

Packaging Options:

• Blister packs (Alu-Alu or PVC-Alu)
• Strip packs with batch info and MRP
• HDPE bottles with tamper-evident seals
• Glass or plastic syrup bottles with child-proof caps
• Cartons with multilingual labels and barcoding
• Bulk packaging for hospitals or government supply

Private Label Support:

• Full assistance with artwork, design, and DTP
• Regulatory-compliant inserts and labels
• Language options: English, French, Spanish, Swahili, Arabic, etc.
• Custom logo printing and branding available

All packaging is compliant with climate stability, tamper resistance, and WHO drug handling guidelines.

Regulatory and Documentation Support

We provide complete regulatory support and export documentation required for importing Ranitidine formulations into your country.

Standard Documents Include:

• WHO-GMP certificate
• Certificate of Pharmaceutical Product (COPP)
• Certificate of Analysis
• Free Sale Certificate
• Product Dossier (CTD or ACTD format)
• Stability and bioequivalence data (on request)
• Labeling mockups and promotional content

Our regulatory team has extensive experience supporting submissions to:

• NAFDAC (Nigeria)
• PPB (Kenya)
• TFDA (Tanzania)
• FMHACA (Ethiopia)
• DRAP (Pakistan)
• SFDA (Saudi Arabia)
• Other MoHs across Asia, Africa, and the Middle East

Private Label and Third-Party Manufacturing Workflow

BluepillExpress streamlines the process of bringing your Ranitidine brand to market with minimal lead time:

Step-by-Step Process:

1. Product Selection – Choose formulation, dosage, and packaging
2. Quotation & Agreement – Finalize pricing, MOQ, and lead time
3. Sample Development – For regulatory or marketing approval
4. Commercial Production – GMP-certified manufacturing
5. Labeling & Packaging – Private-label branding per your design
6. Shipping & Documentation – Worldwide dispatch with all export formalities

We support low MOQ for startups and large-scale bulk orders for NGOs and government procurement.

Target Markets and Export Footprint

BluepillExpress actively exports Ranitidine to clients in:

• Africa: Nigeria, Ghana, Sudan, Kenya, Zambia
• Asia: Myanmar, Nepal, Cambodia, Bangladesh
• Middle East: Yemen, Jordan, Iraq, Lebanon
• Latin America: Haiti, Dominican Republic, Peru
• CIS Countries: Uzbekistan, Kazakhstan, Armenia

We also supply Ranitidine for:

• Government tender programs
• Humanitarian health initiatives
• NGO and WHO project supply
• Private label distribution for retail pharmacies

Our team offers full logistics and customs assistance for smooth global deliveries.

Sustainability and Ethics in Manufacturing

BluepillExpress is committed to ethical, sustainable, and socially responsible manufacturing practices:

• Eco-friendly manufacturing processes
• Zero discharge wastewater treatment systems
• Recyclable packaging materials
• Fair trade raw material sourcing
• Gender-inclusive workforce and no child labor policy
• Support for UN Sustainable Development Goals (SDGs)

We believe in producing medications that improve lives while protecting the environment and supporting ethical trade.

Why Choose BluepillExpress for Ranitidine Manufacturing?

• WHO-GMP certified production
• IP/BP/USP-compliant formulations
• Competitive pricing with scalable capacity
• Full regulatory, documentation, and labeling support
• Customizable private-label solutions
• Strong track record of export and public sector supply
• End-to-end confidentiality and manufacturing integrity

Our clients trust us for on-time delivery, batch reliability, and complete transparency in pharmaceutical contract manufacturing.

Conclusion

Ranitidine continues to be a highly demanded H2-receptor antagonist in numerous global markets, especially in low-to-middle-income countries where cost-effective acid suppression remains crucial for treating ulcers, reflux, and indigestion.

As a dependable partner in third-party pharmaceutical manufacturing, BluepillExpress offers unmatched capabilities in the production, regulatory handling, and global distribution of Ranitidine formulations. Whether you’re looking to launch your private label or fulfill a public tender, we provide the quality, scale, and support you need.