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Crofelemer bulk supplier for pharma manufacturers

Crofelemer 125 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 125 mg

Reference Brands: Fulyzaq (USA)

Category: Gastrointestinal Drugs

Crofelemer is a Gastrointestinal Drugs product available as Tablets in strengths 125 mg. It corresponds to the reference brand Fulyzaq (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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📘 Sourcing Guide

Product Description:

Crofelemer is a plant-derived antidiarrheal agent obtained from the red sap of the South American tree Croton lechleri. It is specifically used for the management of noninfectious diarrhea in HIV-positive patients who are receiving antiretroviral therapy. By acting locally within the gastrointestinal tract, crofelemer helps reduce excess fluid secretion in the intestines, providing symptomatic relief without affecting normal gut motility.

During therapy, crofelemer has been associated with occasional, mild elevations in serum liver enzymes. However, it has not been linked to cases of clinically apparent acute liver injury, making it a well-tolerated option when used under appropriate medical supervision. Its localized mechanism of action allows long-term use for symptom control in eligible patients.

Crofelemer is not intended for the treatment of infectious diarrhea caused by bacteria, viruses, or parasites, as it addresses symptoms rather than underlying infections. The drug was initially developed by Napo Pharmaceuticals, a wholly owned subsidiary of Jaguar Health, Inc. Today, crofelemer remains an important therapeutic option for improving quality of life in patients experiencing chronic, noninfectious diarrhea related to antiretroviral treatment.

Crofelemer — third party manufacturing & bulk supply

Crofelemer 125 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.

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

Manufacturers of Crofelemer 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.

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Frequently Asked Questions


Crofelemer is used for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS who are receiving antiretroviral therapy.


Crofelemer is derived from the purified oligomeric proanthocyanidins obtained from the latex of the Croton lechleri plant.


The trade names of crofelemer include Fulyzaq and Mytesi, depending on the market and branding.


Crofelemer is manufactured and marketed by Napo Pharmaceuticals, a subsidiary of Jaguar Health.


The generic name of the product is crofelemer.


The brand names of crofelemer are Fulyzaq and Mytesi.


Crofelemer is manufactured in GMP-compliant pharmaceutical facilities, primarily in the USA, with controlled sourcing of botanical raw materials.

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