Rebamipide

A Different Philosophy: Healing the Mucosa, Not Just Suppressing Acid

Rebamipide (CAS 90098-04-7), marketed under brand names including Mucosta, is a unique gastroprotective agent that stands apart from conventional acid-suppressing drugs (proton pump inhibitors, H2 antagonists) and antacids. Instead of inhibiting gastric acid secretion or neutralizing existing acid, rebamipide works by directly enhancing the gastric mucosa’s own defensive and repair mechanisms.

Conventional therapies focus on reducing acid attack — an indirect approach that leaves the underlying mucosal damage largely untouched. Rebamipide takes the opposite path: it actively promotes mucosal healing, increases mucus secretion, enhances gastric blood flow, and accelerates epithelial cell regeneration. This mechanism offers particular advantages for patients with chronic gastritis, recurrent ulcers, or those requiring long-term NSAID therapy — where simply suppressing acid is often insufficient.

Moreover, rebamipide possesses potent anti-inflammatory and free radical scavenging properties. It reduces oxidative stress in the gastric epithelium and inhibits the production of pro-inflammatory cytokines (such as IL-8 and TNF-α), addressing the root causes of mucosal injury rather than merely masking symptoms.

At Cosperpharm, we produce Rebamipide API under strict GMP conditions, achieving ≥98% purity by HPLC. We hold a valid pharmaceutical export license, ensuring smooth customs clearance and providing full documentation support for your regulatory filings.

Product Parameters

The above specifications are a comprehensive reference version based on general standards of EMA (Europe) and FDA (USA).

Why Cosperpharm? – Our Competitive Advantages

Therapeutic Indications & Clinical Applications

Primary Indication: Gastric Mucosal Protection

Rebamipide is clinically indicated for:

·Gastric ulcers — accelerates healing and reduces recurrence

·Acute and chronic gastritis — improves inflammation and associated symptoms (epigastric pain, nausea, bloating)

·Prevention of NSAID-induced gastric mucosal injury — particularly valuable for patients requiring long-term NSAID therapy

Beyond the Stomach — Expanding Applications

Rebamipide‘s unique mechanism has led to several off-label and emerging uses:

·Oral mucositis (chemotherapy/radiotherapy-induced): Rebamipide mouthwash or oral tablets have shown efficacy in reducing the severity and duration of oral mucositis in cancer patients. The drug promotes re-epithelialization of damaged oral mucosa through the same prostaglandin-mediated mechanism.

·Xerostomia (dry mouth): In patients with Sjögren‘s syndrome or radiation-induced salivary gland damage, rebamipide has demonstrated improvements in salivary flow and subjective dry mouth symptoms.

·Inflammatory bowel disease (investigational): Some studies suggest potential benefits in ulcerative colitis due to its anti-inflammatory and mucosal healing properties.

·Corneal epithelial disorders (ophthalmic formulation): Available in some countries as eye drops for dry eye disease and corneal epithelial defects.

Clinical Evidence & Key Studies

Gastric Ulcer Healing: Multiple clinical trials have demonstrated that rebamipide significantly improves endoscopic healing rates of gastric ulcers compared to placebo, with efficacy comparable to H2-receptor antagonists (cimetidine, ranitidine) but with a different safety profile — no central nervous system or anti-androgenic effects.

NSAID-Induced Gastropathy: In patients requiring long-term NSAIDs for rheumatoid arthritis or osteoarthritis, rebamipide significantly reduced the incidence of gastric erosions and ulcers. A meta-analysis confirmed that rebamipide is superior to placebo in preventing NSAID-associated gastric damage.

Chronic Gastritis: Rebamipide improves histologic scores of inflammation and alleviates symptoms (epigastric pain, postprandial fullness, nausea) in patients with chronic gastritis, including H. pylori-associated gastritis (as an adjunct to eradication therapy).

Oral Mucositis (Radiotherapy-induced): In a randomized controlled trial of patients receiving radiotherapy for head and neck cancer, rebamipide oral suspension significantly reduced the incidence of severe oral mucositis (grade ≥3) from 68% to 38% (p<0.01) and delayed its onset.

Product Features

Key Selling Points of Rebamipide API:

·First-line gastroprotective agent with unique mucosal healing mechanism

·Distinct from PPIs/H2 antagonists — no acid suppression, no rebound effect

·Multi-target action: prostaglandin induction, free radical scavenging, anti-inflammation

·Well-tolerated for long-term use — excellent safety profile

·Expanding applications: oral mucositis, xerostomia, corneal protection

·Valid export license — Cosperpharm is an authorized API exporter

Production Details & Quality Assurance

Cosperpharm manufactures Rebamipide API in modern GMP multi-purpose workshops equipped with 6 D-grade clean zone production lines. Our 150+ reactors (20L–5000L) support high/low temperature, anaerobic, and hydrogenation conditions, enabling production from kilogram to metric ton scale. Each batch undergoes rigorous QC testing: HPLC, GC, LC-MS, residual solvents (ICH Q3C), heavy metals, and genotoxic impurity analysis. We provide full traceability from raw material to finished API.

FAQ – Frequently Asked Questions

Q1: Is rebamipide an acid reducer?

A: No. Rebamipide does not affect gastric acid secretion or pH. It works by strengthening the gastric mucosa‘s own defense and repair mechanisms, making it fundamentally different from PPIs and H2 antagonists.

Q2: Can rebamipide be used together with PPIs?

A: Yes. In fact, combination therapy is often used for severe or refractory gastric ulcers. Rebamipide heals the existing mucosal damage while the PPI reduces ongoing acid attack — complementary mechanisms.

Q3: What is your MOQ for Rebamipide API?

A: R&D samples: 10g. Commercial orders: 100g–1kg. Larger quantities available upon request.

Q4: What is your typical lead time?

A: In-stock R&D samples: 7 days. Bulk orders: 1-2 months after payment confirmation.

Q5: Which countries have you exported to?

A: USA, Canada, Germany, UK, Spain, India, Brazil, South Korea, Japan, and more. We have experience with local customs and regulatory requirements.

Q6: Can you provide third-party testing or audit?

A: Yes. We welcome customer audits or SGS/BV inspections. Third-party testing can be arranged at buyer‘s cost.

Q7: What certificates do you hold?

A: GMP certificate (ISO 9001:2015), pharmaceutical import/export license, and COA for each batch.

Q8: Do you offer customized packaging?

A: Yes. We can customize packaging size, labeling, and even inner lining materials per your request.

Q9: Is Rebamipide API stable for long-term storage?

A: Yes. When stored at room temperature in an air-tight container protected from light, Rebamipide API remains stable for 36 months. We provide accelerated and long-term stability data upon request.

Contact Us

Ready to buy Rebamipide API? Contact Cosperpharm today for a sample or quote. We look forward to becoming your long-term China Rebamipide supplier.