Racecadotril

Racecadotril is an oral anti-secretory drug widely used in the treatment of acute diarrhea, especially in children and adults. Unlike traditional antimotility agents that alter gut motility, Racecadotril works by inhibiting the enzyme enkephalinase, thus reducing the secretion of water and electrolytes into the intestine without affecting bowel movement. This makes it a safe and effective option in the management of diarrhea, minimizing the risk of complications and enhancing patient comfort.

At BluepillExpress, we offer complete third-party manufacturing services for Racecadotril, in compliance with WHO-GMP, ISO 9001:2015, and relevant pharmacopoeial standards (IP/USP/BP/EP). We provide scalable, customizable, and regulatory-ready solutions for domestic and international markets.

What is Racecadotril?

Racecadotril (also known as acetorphan) is a peripherally acting enkephalinase inhibitor. It inhibits the breakdown of endogenous enkephalins that modulate intestinal secretions. By preserving the enkephalins, Racecadotril reduces hypersecretion in the small intestine, which is a key cause of diarrhea.

Unlike opioids and antimotility agents, Racecadotril:

• Preserves normal gut motility
• Minimizes rebound constipation
• Reduces stool output and frequency
• Has a rapid onset of action
• Is well tolerated across pediatric and adult populations

It is especially favored in pediatric formulations due to its excellent safety profile.

Therapeutic Applications

Racecadotril is indicated for the treatment of acute diarrhea of various etiologies, including viral, bacterial, and parasitic causes. It is also effective as adjunct therapy to oral rehydration solutions (ORS) in both children and adults.

Key Indications:

• Acute diarrhea in children and adults
• Traveler’s diarrhea
• Diarrhea associated with viral infections
• Non-specific acute gastrointestinal disturbances
• Supportive therapy with ORS

Its non-invasive mechanism and lack of effect on gut motility make it ideal for early outpatient management of diarrhea.

Why Choose BluepillExpress for Racecadotril Manufacturing?

BluepillExpress is a globally trusted third-party manufacturer, offering reliable solutions for high-demand molecules like Racecadotril. With cutting-edge manufacturing facilities and extensive industry experience, we ensure efficacy, consistency, and regulatory alignment across every batch.

Key Benefits of Partnering with Us:

• WHO-GMP and ISO 9001:2015 certified manufacturing
• State-of-the-art production lines for suspensions, granules, and capsules
• Pediatric and adult dosage options
• Customizable packaging and flavor options
• End-to-end documentation and regulatory support
• Scalable production with flexible minimum order quantities (MOQs)
• Competitive pricing for domestic and international markets

Whether you are a hospital supplier, pharmaceutical marketing company, or international distributor, we offer tailored solutions to suit your needs.

Available Dosage Forms

1. Racecadotril Oral Suspension (Children)

• Strength: 10 mg/ml or 15 mg/5 ml
• Packaging: 30 ml, 60 ml, 100 ml bottles with child-resistant caps
• Flavors: Strawberry, banana, orange (customizable)
• Indication: Acute pediatric diarrhea
• Preservative-Free and Sugar-Free Options: Available upon request
• Shelf Life: 24–36 months

This formulation is highly accepted by pediatricians and parents alike due to its ease of administration, palatability, and rapid action.

2. Racecadotril Sachets for Children

• Strength: 10 mg or 30 mg sachets
• Packaging: Foil sachets in boxes of 6, 10, or 15
• Dosage: Orally reconstituted with water
• Target Market: Pediatrics aged 3 months to 12 years
• Flavor: Tutti-frutti, banana, lemon (customizable)

A highly portable and stable formulation ideal for hot climates or low-infrastructure areas.

3. Racecadotril Capsules for Adults

• Strength: 100 mg
• Dosage Form: Hard gelatin capsules
• Packaging: Blister/strip packs (10x1x10 or 10×10)
• Labeling: Custom branding and regulatory-compliant printing
• Indication: Acute diarrhea in adults, including traveler’s diarrhea

This dosage form is suitable for retail and institutional supply and offers a convenient once-to-thrice daily dosing regimen.

Manufacturing Infrastructure

At BluepillExpress, our infrastructure is purpose-built to handle high-volume production of both pediatric liquids and solid oral dosage forms.

Facility Features:

• Dedicated liquid and dry powder production lines
• Automatic granulation and sachet-filling machines
• Cleanroom systems for sterile manufacturing
• GMP-compliant HVAC and water purification systems
• Precision blending, encapsulation, and tablet compression units
• Flavoring and homogenization equipment for pediatric formulations
• Barcode-enabled batch tracking and real-time process monitoring

All processes are conducted in accordance with SOPs, and validated to ensure consistency across batches.

Quality Control and Quality Assurance

We follow robust QA/QC protocols to ensure the highest standards of safety, efficacy, and stability.

Quality Parameters:

• Assay of Racecadotril API
• Identity, appearance, and color
• pH, viscosity (for suspension)
• Particle size and re-dispersibility (for sachets)
• Disintegration and dissolution (for capsules)
• Microbial limit testing (especially for pediatric liquids)
• Stability testing (accelerated and long-term)
• Preservative efficacy (if applicable)

All batches are accompanied by:

• Certificate of Analysis (COA)
• Batch Manufacturing Record (BMR)
• Product Specifications
• Stability Summary
• Method of Analysis (MOA)
• Certificate of Origin (COO)

Regulatory Support and Documentation

BluepillExpress offers comprehensive regulatory assistance to support product registration in multiple countries. We have successfully helped partners register Racecadotril in markets across Africa, CIS, Asia, and Latin America.

Our Regulatory Documentation Includes:

• CTD/eCTD/ACTD Dossiers
• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (CoPP)
• Free Sale Certificate (FSC)
• Site Master File (SMF)
• Stability Data
• Bioequivalence Studies (available on request)
• Labels and artwork compliant with local language requirements

We are well-versed in customs, documentation, and regulatory norms in over 35 countries.

Packaging and Branding Solutions

We offer full customization of packaging to meet branding, marketing, and compliance needs.

Packaging Options:

• Glass or PET bottles for suspensions
• Child-safe caps with measuring cups or droppers
• Sachets in aluminum-foil multilayered pouches
• Capsules in strip, blister, or HDPE bottles
• Outer cartons with high-resolution multilingual printing
• Serialized QR-coded packs for anti-counterfeiting
• Promotional kits and sample packs (on request)

Our in-house design team assists with branding, layout, and regulatory proofreading to create compliant and attractive packaging.

Private Label and White Label Solutions

We offer turnkey private labeling services, enabling pharmaceutical marketing companies, startups, and exporters to launch their own Racecadotril brand without investing in manufacturing infrastructure.

Services Include:

• Branding support and visual identity
• Low MOQ for market testing
• Country-specific labeling and artwork
• Product customization (strength, flavor, pack size)
• Dedicated project management and brand confidentiality
• NDA signing and IP protection

Our private-label partners benefit from a quick time-to-market and full regulatory support, enabling efficient brand rollouts.

Export and Global Supply Chain

BluepillExpress supplies Racecadotril formulations to over 35 countries, with a proven track record of successful regulatory approvals, custom clearance, and consistent delivery timelines.

Export Capabilities:

• EXW, FOB, CIF, and DDP delivery
• Air, sea, and road transport
• Temperature-controlled shipping for sensitive suspensions
• Export documentation and pre-shipment inspection
• Freight forwarding and clearance support
• Support for government tenders, NGOs, and institutional buying

Our logistics team ensures that Racecadotril products reach clients on time, in full compliance, and in optimal condition.

Minimum Order Quantities (MOQ)

We accommodate clients of all sizes, offering flexible MOQ structures based on product type and packaging preferences.

• Small pilot batches for registration and brand testing
• Medium batches for hospitals or regional distribution
• Bulk production for tenders or nationwide retail launches
• Contract manufacturing with yearly agreements

Our team will work with you to define the right production scale for your needs.

Client Testimonials

“Our pediatric Racecadotril syrup, manufactured by BluepillExpress, has become a top seller in our market. Excellent quality, flavor, and regulatory support.”
— Pediatric Brand Owner, East Africa

“BluepillExpress supported us through the dossier process and helped us register our product within months. Truly reliable and efficient.”
— Regulatory Consultant, Southeast Asia

“We appreciated their packaging design services and attention to pediatric safety. Our Racecadotril sachets have been a great success.”
— Marketing Head, Middle East

Conclusion

Racecadotril continues to be a critical therapeutic agent in the management of acute diarrhea, especially in children. With global demand rising for safe, effective, and affordable antidiarrheal medications, pharmaceutical companies have an opportunity to expand their offerings in this high-utility therapeutic segment.

At BluepillExpress, we bring together manufacturing excellence, regulatory competence, and customer-centered service to deliver premium-quality Racecadotril formulations. Whether you’re looking for pediatric suspensions, sachets, or adult capsules, we are your trusted partner in third-party and contract manufacturing.