Racecadotril Capsule bulk supplier for pharma manufacturers

Racecadotril Capsule 100 mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 100 mg

Reference Brands: Hidrasec(US & EU)

Racecadotril capsules are enkephalinase inhibitors that reduce intestinal secretion by blocking enkephalin breakdown. They effectively treat diarrhea, decrease stool volume, and relieve symptoms quickly. Benefits include fewer side effects, supporting hydration, and promoting faster recovery in acute diarrhea, especially in children and adults.

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Product Description: Racecadotril capsules, marketed as Hidrasec, are approved in select regions of the EU and in the US for diarrhea treatment. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Proper adherence to regional regulations supports swift approval, safe use, and global availability, helping manage acute diarrhea in pediatric and adult patients worldwide effectively.

Racecadotril Capsule — third party manufacturing & bulk supply

Racecadotril Capsule 100 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Racecadotril Capsule is supplied as Capsules — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Racecadotril Capsule listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Racecadotril Capsule is listed as Capsules in 100 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Racecadotril Capsule is referenced against Hidrasec(US & EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.