Racecadotril Capsule 100 mg Suppliers & Bulk Manufacturers
Available Forms: Capsules
Available Strengths: 100 mg
Reference Brands: Hidrasec(US & EU)
Category: Gastrointestinal Drugs
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.
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:
What to include when you enquire
- Destination market — determines which manufacturers hold the right site-level approvals
- First order quantity and estimated annual volume
- Whether you need a registration dossier or the product is already registered
- Packaging, labelling and language requirements
- Incoterms and required shelf life
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. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.
Request a quote for Racecadotril Capsule →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
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