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Flubendazole API Manufacturers & Suppliers
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Flubendazole | CAS No: 31430-15-6 | GMP-certified suppliers
A medication that treats helminthic infections by providing broad-spectrum antiparasitic efficacy with established benzimidazole anthelmintic properties for human therapeutic use.
Therapeutic categories
Product Snapshot
- Flubendazole is formulated primarily as oral suspensions and tablets
- It is mainly utilized for antiparasitic therapy targeting helminth infections
- Flubendazole is an experimental drug in the US market with its approval subsequently withdrawn
Clinical Overview
Although flubendazole is available over-the-counter in some European countries, detailed clinical indications, pharmacodynamics, and exact mechanisms of action have not been fully delineated in regulatory or clinical literature. The compound is generally understood to exert antiparasitic effects through interference with parasite microtubule function, a common mechanism among benzimidazole anthelmintics. This action inhibits the polymerization of tubulin, disrupting the cytoskeleton of parasitic worms and leading to their eventual immobilization and death.
Pharmacokinetic data remain limited, but benzimidazole derivatives typically exhibit poor systemic absorption due to low solubility, which may influence therapeutic efficacy and safety. Metabolism and elimination pathways are not comprehensively described, nor are detailed ADME parameters readily available for flubendazole.
Safety and toxicity profiles have not been extensively characterized in humans; however, as with other benzimidazoles, attention to potential teratogenicity, hepatotoxicity, and hematological effects is prudent. Notably, the drug has been categorized as experimental and withdrawn in some contexts, suggesting variable regulatory acceptance and use.
Flubendazole is marketed under various generic and regional brand names and has broad application in controlling nematodal infections in both human and veterinary settings.
From an API sourcing and quality perspective, flubendazole requires stringent adherence to pharmacopeial standards to ensure purity, potency, and stability. Suppliers should provide comprehensive certificates of analysis, including impurity profiles and batch-to-batch consistency data, to support regulatory compliance and product safety. Due to limited global approval and variable clinical use, careful evaluation of manufacturing practices and regulatory status by procuring organizations is advised.
Identification & chemistry
| Generic name | Flubendazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 31430-15-6 |
| UNII | R8M46911LR |
| DrugBank ID | DB08974 |
Formulation & handling
- Flubendazole is a small molecule suitable primarily for oral administration in various solid and suspension dosage forms.
- Low water solubility (approximately 0.03 g/L) indicates the need for formulation strategies to enhance bioavailability.
- Given its classification as a stable benzophenone derivative, standard handling procedures apply without special sensitivity to light or temperature.
Regulatory status
| Lifecycle | The API's primary patents have expired, allowing for generic competition in the US market. As a result, the product is in the mature phase of its lifecycle with widespread availability across multiple manufacturers. |
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| Markets | US |
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Supply Chain
| Supply chain summary | Flubendazole is currently marketed in the US, with branded products such as Zelcom available. The presence of branded formulations suggests originator companies maintain a market role primarily in the US. Depending on patent status, generic competition may be present or anticipated, reflecting typical dynamics post-patent expiry in this market. |
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Flubendazole is a type of Anthelmintics
Anthelmintics belong to the pharmaceutical API subcategory used in the treatment of parasitic infections caused by helminths, commonly known as worms. These parasitic infections can affect various parts of the body, including the intestines, liver, and lungs. Anthelmintics act by either paralyzing or killing the helminths, thereby eliminating the infection.
There are different classes of anthelmintics, each targeting specific types of helminths. The benzimidazoles class includes compounds like albendazole and mebendazole, which disrupt the energy metabolism of the worms, leading to their paralysis and eventual death. Another class is the avermectins, which includes ivermectin and moxidectin. These compounds work by affecting the neurotransmitter functions in the worms, resulting in paralysis and death.
Anthelmintics are available in various formulations, including tablets, suspensions, and injectables, allowing for convenient administration to patients. Depending on the type and severity of the infection, the duration of treatment may vary.
When using anthelmintics, it is crucial to follow the prescribed dosage and duration to ensure the effective elimination of the parasitic infection. However, as with any medication, there may be potential side effects, such as gastrointestinal disturbances or allergic reactions, which should be monitored.
In conclusion, anthelmintics are a vital class of pharmaceutical APIs used to combat parasitic infections caused by helminths. Their targeted action and diverse range of formulations make them an essential tool in the fight against these debilitating conditions.
Flubendazole (Anthelmintics), classified under Antiparasitics
Antiparasitics are a category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that are used to combat parasitic infections in humans and animals. These APIs play a crucial role in the field of medicine and veterinary care by targeting and eliminating various parasites, such as protozoa, helminths, and ectoparasites.
The use of antiparasitics is essential in preventing and treating parasitic diseases, which can cause significant health issues and even be life-threatening. These APIs work by interfering with the parasite's vital biological processes, such as reproduction, metabolism, and survival mechanisms.
Pharmaceutical companies develop and manufacture a wide range of antiparasitic APIs to cater to different parasitic infections. Some common examples of antiparasitics include anthelmintics (used against intestinal worms), antimalarials (used to treat malaria), and ectoparasiticides (used to control external parasites like ticks and fleas).
The development of antiparasitic APIs requires rigorous research, including the identification of suitable targets within the parasite's biology and the formulation of effective chemical compounds. Safety and efficacy are paramount in the manufacturing of antiparasitics, ensuring that they effectively combat the targeted parasites while minimizing adverse effects on the host.
Overall, antiparasitics are vital tools in the fight against parasitic infections, benefiting both human and animal health. Through ongoing research and development, the pharmaceutical industry continues to innovate and improve antiparasitic APIs, contributing to the advancement of healthcare and the well-being of individuals and their animal companions.
Flubendazole API manufacturers & distributors
Compare qualified Flubendazole API suppliers worldwide. We currently have 5 companies offering Flubendazole API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, EDMF/ASMF, GMP, ISO9001, USDMF | 235 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| Janssen Pharma | Producer | Belgium | Unknown | CEP, CoA, GMP | 63 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, USDMF | 757 products |
When sending a request, specify which Flubendazole API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Flubendazole API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
