Crofelemer Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 125 mg
Reference Brands: Fulyzaq (USA)
Category: Gastrointestinal Drugs
Crofelemer is available in Tablets and strengths such as 125 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Crofelemer is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Crofelemer can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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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