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Mebendazole | CAS No: 31431-39-7 | GMP-certified suppliers
A medication that treats common intestinal nematode infections, including pinworm, whipworm, roundworm, and hookworm, supporting broad antiparasitic needs in key markets.
Therapeutic categories
Primary indications
- For the treatment of <i>Enterobius vermicularis</i> (pinworm), <i>Trichuris trichiura</i> (whipworm), <i>Ascaris lumbricoides</i> (common roundworm), <i>Ancylostoma duodenale</i> (common hookworm), <i>Necator americanus</i> (American hookworm) in single or mixed infections
Product Snapshot
- Mebendazole is an oral small‑molecule anthelmintic supplied in tablets, chewable tablets, suspensions, granules, and syrups
- It is used for control of Enterobius, Trichuris, Ascaris, Ancylostoma, and Necator helminth infections in single or mixed infestations
- It is approved for human use in the US and Canada, with additional veterinary approvals
Clinical Overview
The compound is structurally classified within the benzophenone family and functions as a synthetic broad‑spectrum antiparasitic agent. Its pharmacodynamic effect is primarily driven by inhibition of tubulin polymerization, leading to loss of cytoplasmic microtubules in susceptible helminths.
Mebendazole acts by binding to colchicine‑sensitive sites on tubulin, blocking polymerization and disrupting the formation of microtubules in parasite intestinal and tegumental cells. This results in impaired glucose uptake, depletion of glycogen stores, and a cascade of degenerative intracellular changes involving the endoplasmic reticulum, mitochondria, and lysosomes. Reduced ATP production compromises parasite energy metabolism, leading to immobilization and death of the larval and adult stages.
Oral absorption is limited due to poor aqueous solubility, and systemic exposure may vary with formulation and fed state. Mebendazole undergoes hepatic metabolism, with metabolites generally showing lower anthelmintic activity. Elimination occurs mainly through fecal excretion of unchanged drug. Systemic concentrations remain low at standard doses used for intestinal infections.
Safety considerations include the potential for gastrointestinal disturbances and, at higher exposures or prolonged use, rare hepatotoxicity or hematologic changes. Use in pregnancy is restricted in some regions due to limited data. Drug interactions may occur with agents affecting hepatic metabolism.
Common usage contexts include mass drug administration programs, treatment of household transmission clusters, and targeted therapy based on stool diagnostic findings. Various branded and generic products exist globally, differing primarily in formulation.
For API procurement, attention should focus on confirmed identity, control of polymorphic form, particle size distribution, and impurity limits to support consistent bioavailability and compliance with pharmacopeial standards.
Identification & chemistry
| Generic name | Mebendazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 31431-39-7 |
| UNII | 81G6I5V05I |
| DrugBank ID | DB00643 |
Pharmacology
| Summary | Mebendazole is a broad‑spectrum anthelmintic that targets parasitic tubulin, primarily the alpha‑1A and beta‑4B chains, disrupting microtubule formation. This inhibition impairs glucose uptake and depletes glycogen stores, leading to reduced ATP production and functional immobilization of the parasite. The resulting metabolic failure causes progressive degeneration of helminth intestinal and cellular structures. |
|---|---|
| Mechanism of action | Mebendazole causes degenerative alterations in the tegument and intestinal cells of the worm by binding to the colchicine-sensitive site of tubulin, thus inhibiting its polymerization or assembly into microtubules. The loss of the cytoplasmic microtubules leads to impaired uptake of glucose by the larval and adult stages of the susceptible parasites, and depletes their glycogen stores. Degenerative changes in the endoplasmic reticulum, the mitochondria of the germinal layer, and the subsequent release of lysosomes result in decreased production of adenosine triphosphate (ATP), which is the energy required for the survival of the helminth. Due to diminished energy production, the parasite is immobilized and eventually dies. |
| Pharmacodynamics | Mebendazole is a (synthetic) broad-spectrum anthelmintic. The principal mode of action for Mebendazole is by its inhibitory effect on tubulin polymerization which results in the loss of cytoplasmic microtubules. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Tubulin alpha-1A chain | Humans | inhibitor |
| Tubulin beta-4B chain | Humans | inhibitor |
ADME / PK
| Absorption | Poorly absorbed (approximately 5 to 10%) from gastrointestinal tract. Fatty food increases absorption. |
|---|---|
| Half-life | 2.5 to 5.5 hours (range 2.5 to 9 hours) in patients with normal hepatic function. Approximately 35 hours in patients with impaired hepatic function (cholestasis). |
| Protein binding | 90-95% |
| Metabolism | Primarily hepatic. Primary metabolite is 2-amino-5-benzoylbenzimidazole, but also metabolized to inactive hydroxy and hydroxyamino metabolites. All metabolites are devoid of anthelmintic activity. |
| Route of elimination | In man, approximately 2% of administered mebendazole is excreted in urine and the remainder in the feces as unchanged drug or a primary metabolite. |
Formulation & handling
- Low aqueous solubility and moderate lipophilicity require formulation approaches for oral delivery such as particle size reduction or solid dispersions to enhance dissolution.
- Stable as a solid small molecule; typical oral solid and liquid dosage forms are suitable with standard handling for poorly soluble APIs.
- Food has minimal impact on absorption, allowing flexible administration without special excipient strategies for food‑dependent bioavailability.
Regulatory status
| Lifecycle | Patent expiry in the US and Canada places this API in a mature stage of its lifecycle, with established market presence and potential for continued generic participation. Market dynamics are largely shaped by post‑expiry competition and stable demand. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Mebendazole is supplied by a small number of originator and long‑established manufacturers, with Teva and McNeil historically associated with branded formulations. Branded products such as Emverm are marketed primarily in the US and Canada, alongside wide distribution through numerous repackagers. Patent expiry occurred long ago, and the product is now fully generic with broad multi‑supplier competition. |
|---|
Safety
| Toxicity | Acute oral toxicity (LD<sub>50</sub>): 620 mg/kg [Mouse]. Symptoms of overdose include elevated liver enzymes, headaches, hair loss, low levels of white blood cells (neutropenia), fever, and itching. |
|---|
- Exhibits moderate acute oral toxicity (mouse LD50 ≈ 620 mg/kg), warranting controlled handling and appropriate containment during processing
- Overexposure may manifest as hepatic enzyme elevations, hematologic effects such as neutropenia, and dermal or systemic symptoms including pruritus, headache, fever, and alopecia
- Monitoring for potential liver and marrow stress is advised in manufacturing environments involving repeated or high‑level API contact
Mebendazole 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.
Mebendazole (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.
Mebendazole API manufacturers & distributors
Compare qualified Mebendazole API suppliers worldwide. We currently have 12 companies offering Mebendazole API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Aarambh Life Science | Producer | India | India | CoA, GMP | 19 products |
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| Aquatic Remedies Pvt Ltd | Producer | India | India | CoA | 35 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, EDMF/ASMF, GMP, ISO14001, ISO9001, MSDS | 235 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| Cipla | Producer | India | India | CoA, USDMF | 164 products |
| KA Malle Pharmaceuticals | Producer | India | India | CoA | 2 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| MSN Life Sciences | Producer | India | India | CoA, USDMF | 46 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
When sending a request, specify which Mebendazole 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 Mebendazole 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.
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