Cimetidine

Gastrointestinal disorders, including acid reflux, peptic ulcers, and indigestion, affect millions globally, significantly impacting quality of life and healthcare systems. One of the earliest and most trusted therapies for managing acid-related disorders is Cimetidine, a histamine H2-receptor antagonist that revolutionized ulcer treatment and continues to serve as a cost-effective solution in various markets.

BluepillExpress, a WHO-GMP certified pharmaceutical manufacturing company, offers third-party manufacturing services for Cimetidine formulations including tablets and syrups. With a commitment to pharmaceutical excellence and global distribution capabilities, BluepillExpress provides high-quality, regulatory-compliant products tailored for both institutional and branded segments.

Product Overview

Generic Name: Cimetidine
Pharmacological Category: H2-Receptor Antagonist
Therapeutic Use: Antacid / Antiulcer / Gastroprotective Agent

Available Dosage Forms:

• Tablets
• Oral Syrup (for pediatric and geriatric use)

Common Strengths:

• Tablets: 200 mg, 400 mg, 800 mg
• Syrup: 200 mg/5 mL

Packaging Options:

• Tablets: Blister packs (10×10, 1×10), Alu-Alu or PVC-Alu
• Syrup: HDPE or glass bottles (60 mL, 100 mL, 150 mL, 200 mL)
• Carton Packaging: Multilingual, serialized, and customizable
• Institutional packs and export packaging available on demand

Pharmacopoeial Compliance: IP / BP / USP / WHO (as per market requirement)

Mechanism of Action

Cimetidine selectively blocks H2 receptors on the gastric parietal cells, which are responsible for acid secretion. By inhibiting the action of histamine on these receptors, it significantly reduces both basal and stimulated gastric acid secretion.

Key Effects:

• Reduces gastric volume and hydrogen ion concentration
• Lowers pepsin output
• Promotes ulcer healing by maintaining a less acidic gastric environment

It does not neutralize acid like antacids, but rather prevents acid production, making it ideal for long-term management of acid-peptic disorders.

Indications

Cimetidine is indicated for the treatment and prevention of:

• Duodenal ulcers and gastric ulcers
• Zollinger-Ellison Syndrome (pathological hypersecretory condition)
• Gastroesophageal reflux disease (GERD)
• Heartburn, sour stomach, and acid indigestion
• Erosive esophagitis
• Stress-induced gastric ulcers (in hospitalized patients)
• Pre-anesthetic medication to reduce aspiration risk
• Prophylaxis of NSAID-induced ulcers

Dosage and Administration

Tablets:

• Usual adult dose:
  • 400 mg twice daily or 800 mg once daily at bedtime for ulcer healing
  • 200 mg taken with meals and at bedtime for GERD or indigestion
• Maintenance dose: 400 mg at bedtime

Syrup:

• For pediatric or elderly patients who have difficulty swallowing tablets
• Dose: 200–400 mg (5–10 mL) taken 2–4 times daily based on clinical need

Course Duration:

• Typically 4 to 8 weeks for ulcer healing
• Maintenance therapy may be continued for relapse prevention

Special Populations:

• Dose adjustment may be required in renal impairment
• Caution in elderly patients due to altered metabolism

Pharmacokinetics

• Absorption: Well-absorbed orally; bioavailability ~60–70%
• Onset of Action: ~30 minutes
• Duration of Action: 4–6 hours (standard dose)
• Half-life: 2–3 hours (prolonged in renal impairment)
• Excretion: Primarily via kidneys (unchanged and metabolites)

Advantages of Cimetidine Therapy

• Cost-effective treatment for acid-related disorders
• Wide global use and long-standing clinical validation
• Ideal for low-resource settings and public health supply
• Safe for short-term and maintenance therapy
• Available in multiple dosage forms (oral solid and liquid)
• Alternative to proton pump inhibitors (PPIs) in specific patient populations

Why Choose BluepillExpress for Third-Party Manufacturing?

1. WHO-GMP Certified Facilities

Our manufacturing units meet global standards with dedicated oral solid and liquid manufacturing zones:

• Tablet compression and coating lines
• Liquid oral formulation suites
• Cleanroom environments for contamination control
• End-to-end automation ensuring precision and consistency

2. Flexible Manufacturing and Customization

• Customizable strengths, flavors (for syrups), and packaging options
• Alcohol-free, sugar-free, and preservative-free variants available
• Branded or unbranded bulk supply options
• Support for institutional, tender, or branded private-label supply

3. Regulatory and Documentation Support

We provide full regulatory documentation for global registration and tenders:

• Certificate of Analysis (COA)
• Free Sale Certificate (FSC)
• Certificate of Pharmaceutical Product (COPP)
• ICH stability data
• Bioequivalence studies (if applicable)
• Dossier preparation in CTD/ACTD format
• Pharmacovigilance data for long-term safety profile

4. Global Export and Logistics Network

BluepillExpress exports to over 40 countries, ensuring timely supply and documentation:

• Africa: Nigeria, Ghana, Kenya, Sudan, Ethiopia
• Asia: Philippines, Bangladesh, Vietnam, Myanmar
• CIS and LATAM: Uzbekistan, Bolivia, Honduras
• Middle East: Iraq, Jordan, Yemen

We provide serialization, QR code integration, and anti-counterfeit packaging as required.

Quality Control and Assurance

Our products are tested at every manufacturing stage to ensure safety, efficacy, and compliance.

Tests Conducted:

• API assay and identity testing
• Content uniformity and dissolution
• pH, viscosity, and stability (for syrups)
• Microbial limit tests
• Packaging integrity testing
• Accelerated and real-time stability studies

Our QC labs are equipped to meet IP, USP, BP, and WHO quality standards.

Third-Party Manufacturing Process

Step 1: Product and Market Discussion
Finalize product specs, target markets, dosage forms, and regulatory needs.

Step 2: Sample Development and Validation
Pilot batches and packaging samples are shared for evaluation.

Step 3: Documentation and Commercials
COAs, technical documents, and commercial quotes are finalized.

Step 4: Full-Scale Production
Manufacturing begins in GMP zones with rigorous in-process quality checks.

Step 5: Packing and Shipment
Finished products are packed, labeled, and dispatched with export documentation.

Step 6: Regulatory Support
Post-shipment assistance for MOH submissions, variations, or renewals.

Target Clients and Applications

Cimetidine is ideal for clients focused on:

• OTC gastrointestinal brands
• Hospitals and clinical procurement
• Government and NGO tenders
• Exporters and distributors in regulated and semi-regulated markets
• Online pharmacy platforms
• Medical missions and humanitarian health programs

Its low cost, safety profile, and wide therapeutic window make it suitable for national health programs and affordable medicine portfolios.

Global Market Outlook

Although proton pump inhibitors dominate the modern market, Cimetidine remains in demand due to:

• Its effectiveness in acute relief of symptoms
• Use in elderly patients or where PPIs are contraindicated
• Inclusion in essential medicine lists of many countries
• Preference in low-cost healthcare systems and bulk supply tenders

The market for generic anti-ulcer drugs like Cimetidine continues to grow steadily in Africa, Asia, and Latin America, with a CAGR of 5–7% driven by demand in the public health sector.

Conclusion

Cimetidine stands as a foundational treatment in the management of acid-peptic disorders, offering reliable efficacy and excellent tolerability. For pharmaceutical companies, hospitals, and governments aiming to provide affordable gastrointestinal solutions, Cimetidine remains a cornerstone product.

BluepillExpress offers comprehensive third-party manufacturing services for Cimetidine tablets and syrups with the assurance of quality, compliance, and global logistics support. Whether you’re expanding your gastroenterology portfolio or supplying government contracts, we provide the flexibility and capacity to meet your goals.