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Albendazole | CAS No: 54965-21-8 | GMP-certified suppliers
A medication that treats neurocysticercosis and cystic hydatid disease, offering reliable antiparasitic control for supplying essential tapeworm infection therapies in global healthcare markets.
Therapeutic categories
Primary indications
- For the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, <i>Taenia solium</i> and for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, <i>Echinococcus granulosus</i>
Product Snapshot
- Oral small‑molecule antiparasitic available in tablets, capsules, suspensions, syrups, and chewable formats
- Used for management of parenchymal neurocysticercosis and cystic hydatid disease
- Approved in the US, including human and veterinary approvals
Clinical Overview
Albendazole exhibits broad-spectrum activity against cestodes and nematodes. Pharmacodynamic activity is primarily mediated through inhibition of tubulin polymerization, resulting in disrupted cytoplasmic microtubules. This impairment blocks glucose uptake in susceptible parasites, leading to depletion of glycogen reserves and reduction in ATP generation. The consequent energy deficit produces degenerative changes in the tegument and intestinal cells, ultimately causing immobilization and death of the parasite.
Albendazole undergoes hepatic metabolism, with its active metabolite albendazole sulfoxide contributing to systemic activity. Absorption is variable and increases when administered with fatty meals. The compound and its metabolites interact with cytochrome P450 enzymes, including CYP1A2, CYP2C19, and CYP3A family isoforms, and are substrates of P‑glycoprotein. These characteristics support the potential for clinically relevant drug interactions. Elimination occurs primarily via the hepatobiliary route.
Safety considerations include the potential for hepatic enzyme elevations and hematologic effects such as leukopenia, particularly with prolonged therapy. Use in individuals with pre-existing liver disease requires caution, and periodic laboratory monitoring is generally recommended during extended treatment courses. Albendazole is approved for human use and also has established veterinary applications, with well-recognized global brand representations in both settings.
For API procurement, suppliers should provide material manufactured under appropriate GMP conditions with full impurity profiling, validated control of polymorphic form, and assurance of compliance with regional pharmacopoeial specifications where applicable.
Identification & chemistry
| Generic name | Albendazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 54965-21-8 |
| UNII | F4216019LN |
| DrugBank ID | DB00518 |
Pharmacology
| Summary | Albendazole is a broad‑spectrum anthelmintic that disrupts parasite energy metabolism by inhibiting tubulin polymerization and the formation of cytoplasmic microtubules. This inhibition impairs glucose uptake and depletes glycogen stores, leading to reduced ATP production and structural degeneration within susceptible helminths. Its primary molecular targets include several alpha and beta tubulin isoforms and a fumarate reductase subunit. |
|---|---|
| Mechanism of action | Albendazole causes degenerative alterations in the tegument and intestinal cells of the worm by diminishing its energy production, ultimately leading to immobilization and death of the parasite. It works by binding to the colchicine-sensitive site of tubulin, thus inhibiting its polymerization or assembly into microtubules. As cytoplasmic microtubules are critical in promoting glucose uptake in larval and adult stages of the susceptible parasites, the glycogen stores of the parasites are depleted. 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. |
| Pharmacodynamics | Albendazole is a broad-spectrum anthelmintic. The principal mode of action for albendazole is by its inhibitory effect on tubulin polymerization which results in the loss of cytoplasmic microtubules. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Tubulin beta-2 chain | Pig roundworm | inhibitor |
| Tubulin alpha-1A chain | Humans | inhibitor |
| Tubulin beta-4B chain | Humans | inhibitor |
ADME / PK
| Absorption | Poorly absorbed from the gastrointestinal tract due to its low aqueous solubility. Oral bioavailability appears to be enhanced when coadministered with a fatty meal (estimated fat content 40 g) |
|---|---|
| Half-life | Terminal elimination half-life ranges from 8 to 12 hours (single dose, 400mg). |
| Protein binding | 70% bound to plasma protein |
| Metabolism | Hepatic. Rapidly converted in the liver to the primary metabolite, albendazole sulfoxide, which is further metabolized to albendazole sulfone and other primary oxidative metabolites that have been identified in human urine. |
| Route of elimination | Albendazole is rapidly converted in the liver to the primary metabolite, albendazole sulfoxide, which is further metabolized to albendazole sulfone and other primary oxidative metabolites that have been identified in human urine. Urinary excretion of albendazole sulfoxide is a minor elimination pathway with less than 1% of the dose recovered in the urine. Biliary elimination presumably accounts for a portion of the elimination as evidenced by biliary concentrations of albendazole sulfoxide similar to those achieved in plasma. |
Formulation & handling
- Albendazole is an oral small‑molecule benzimidazole with very low aqueous solubility, requiring formulation approaches that enhance dissolution for reliable bioavailability.
- Absorption is food‑dependent; coadministration with high‑fat meals increases solubility and systemic exposure, which should be considered in product design and labeling.
- Solid oral forms and suspensions should control polymorphism and particle size to maintain consistent dissolution performance.
Regulatory status
| Lifecycle | Insufficient patent‑expiry information was provided, so only a general lifecycle statement is possible. In the US market, lifecycle maturity depends on whether key patents have expired; once they do, products typically transition to a generic‑competitive phase, indicating a mature market landscape. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Albendazole is supplied primarily by a single listed originator manufacturer, with several U.S.-based packagers supporting downstream distribution. The branded product presence appears limited to the U.S. market, with no additional regions indicated. Patent expiry for this long‑established antiparasitic suggests that generic competition is already present or well established. |
|---|
Safety
| Toxicity | Symptoms of overdose include elevated liver enzymes, headaches, hair loss, low levels of white blood cells (neutropenia), fever, and itching. |
|---|
- Overexposure has been associated with hepatocellular stress, reflected by elevated liver enzyme levels
- Reported toxicity profile includes hematologic effects such as neutropenia, along with systemic reactions including fever and headache
- Dermal and follicular responses (itching and reversible alopecia) have been observed at higher exposure levels
Albendazole 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.
Albendazole (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.
Albendazole API manufacturers & distributors
Compare qualified Albendazole API suppliers worldwide. We currently have 17 companies offering Albendazole API, with manufacturing taking place in 2 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 |
| AMARI TRADE ALLIANEC LLP | Distributor | India | India | CoA | 15 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Beijing Infoark Co Ltd | Producer | China | China | CoA | 1 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, EDMF/ASMF, GMP, ISO14001, ISO9001, MSDS, USDMF | 235 products |
| Chr. Olesen Group | Distributor | Denmark | China | CoA, GMP, MSDS, USDMF | 252 products |
| Cipla | Producer | India | India | CoA, USDMF | 164 products |
| Enaltec Labs | Producer | India | India | CoA, WC | 16 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| KA Malle Pharmaceuticals | Producer | India | India | CoA | 2 products |
| MSN Life Sciences | Producer | India | India | CoA, USDMF | 46 products |
| Punjab Chemicals & Crop | Producer | India | India | CoA, GMP, WC | 5 products |
| Sequent Scientific | Producer | India | India | CEP, CoA, FDA | 8 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| United Pharma Industries ... | Distributor | China | China | CoA | 12 products |
When sending a request, specify which Albendazole 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 Albendazole 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.
Frequently asked questions about Albendazole API
Sourcing
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Technical
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Regulatory
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