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Praziquantel | CAS No: 55268-74-1 | GMP-certified suppliers
A medication that treats schistosomiasis and liver fluke infections across key endemic species, supporting reliable antiparasitic management needs for global and North American health programs.
Therapeutic categories
Primary indications
- Praziquantel is indicated in patients aged 1 year and older for the treatment of the schistosomiasis due to all species of Schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium) and clonorchiasis and opisthorchiasis due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini (approval of this indication was based on studies in which the two species were not differentiated)
Product Snapshot
- Praziquantel is an oral small‑molecule anthelmintic available mainly as film‑coated tablets, coated tablets, paste, and powder
- It is used for schistosomiasis caused by all major Schistosoma species and for liver fluke infections such as clonorchiasis and opisthorchiasis
- It holds approved status in the United States and Canada, with additional investigational and veterinary approvals in other markets
Clinical Overview
Praziquantel alters parasite membrane permeability, producing rapid contraction of adult schistosomes and subsequent vacuolization and disruption of the tegument. Increased Ca2+ influx is thought to contribute to this response. Secondary effects include reduced glucose uptake, depletion of glycogen stores, and increased lactate release. Activity is limited to trematodes and cestodes, with no effect on nematodes. Sensitivity varies across parasite life stages, with reduced susceptibility in juvenile schistosomes and migrating schistosomula.
The mechanism of action is not fully defined. Evidence suggests interaction with beta subunits of voltage‑gated Ca2+ channels in schistosomes, supported by reduced praziquantel susceptibility when calcium channel blockers are co‑administered. Enhanced exposure of surface antigens on parasites has been observed, although its mechanistic role remains unclear.
Praziquantel is orally administered and extensively metabolized, primarily through CYP3A pathways, with contributions from CYP1A2 and CYP2C19. It undergoes significant first‑pass metabolism, resulting in high systemic levels of inactive metabolites. The compound shows rapid absorption, wide tissue distribution, and predominantly renal elimination of metabolites. Safety considerations include transient gastrointestinal and CNS effects, with more pronounced symptoms in individuals with heavy parasite burdens due to parasite destruction.
Praziquantel is marketed in numerous generic formulations and is included in international neglected‑tropical‑disease control programs. For API procurement, manufacturers should verify control of stereochemistry, impurity profiles, residual solvent levels, and demonstrate compliance with pharmacopoeial specifications and robust process consistency suitable for large‑scale public health supply chains.
Identification & chemistry
| Generic name | Praziquantel |
|---|---|
| Molecule type | Small molecule |
| CAS | 55268-74-1 |
| UNII | 6490C9U457 |
| DrugBank ID | DB01058 |
Pharmacology
| Summary | Praziquantel is an antiparasitic agent that perturbs calcium ion homeostasis in trematodes and cestodes, likely through interactions with schistosome voltage‑gated calcium channel β subunits. This disruption increases membrane permeability, leading to muscular contraction and tegumental damage, with downstream effects on glucose metabolism. Its activity is species‑specific and shows reduced effectiveness against juvenile schistosomes. |
|---|---|
| Mechanism of action | Although the exact mechanism of action is unknown, praziquantel was hypothesized to target the β subunits of voltage-gated Ca<sub>2+</sub> channels, particularly in Schistosoma mansoni and Schistosoma japonicum, due to the lack of two conserved serine residues in these subunits. This is supported by the finding that co-administration of calcium channel blockers like nicarpidine and nifedipine renders 50% of Schistosoma mansoni resistant to praziquantel. Increased exposure of antigens on the worm surface was also observed, but little research has been done to elucidate on the mechanism of action. |
| Pharmacodynamics | In vitro studies on trematodes and cestodes have shown that praziquantel induces a rapid contraction of schistosomas by a specific effect on the permeability of the cell membrane. The drug further causes vacuolization and disintegration of the schistosome tegument. The effect is more marked on adult worms compared to young worms. An increased Ca2<sup>+</sup>-influx may play an important role. Secondary effects are inhibition of glucose uptake, lowering of glycogen levels and stimulation of lactate release. The action of praziquantel is specific to trematodes and cestodes; nematodes (including filariae) are not affected. Praziquantel is active against schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium), and infections due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini. Published in vitro data have shown a potential lack of efficacy of praziquantel against migrating schistosomulae. An interesting quirk of praziquantel is that it is relatively ineffective against juvenile schistosomes. While initially effective, effectiveness against schistosomes decreases until it reaches a minimum at 3-4 weeks. Effectiveness then increases again until it is once again fully effective at 6-7 weeks. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Schistosome calcium ion (Ca2+) channels | Schistosoma | other/unknown |
ADME / PK
| Absorption | After oral administration of praziquantel, about 80% of the dose is absorbed. In subjects with normal hepatic function who received 40 mg/kg of praziquantel under fasting conditions, the mean ± SD C<sub>max</sub> and AUC were 0.83 ± 0.52 µg/mL and 3.02 ± 0.59 µg/mL x hr. The T<sub>max</sub> was 1.48 ± 0.74 hours. |
|---|---|
| Half-life | Following oral administration, the elimination half-life of praziquantel in serum ranges between 0.8 to 1.5 hours. |
| Protein binding | Approximately 80% of praziquantel is bound exclusively to albumin. |
| Metabolism | Praziquantel is rapidly metabolized by the cytochrome P450 enzyme system and undergoes a first-pass effect after oral administration. |
| Route of elimination | Approximately 80% of an oral dose of praziquantel is excreted in the kidneys, almost exclusively (greater than 99%) in the form of praziquantel metabolites. |
| Volume of distribution | Following a single oral dose of 40 mg/kg of praziquantel in healthy volunteers, the volume of distribution was estimated to be 7695 ± 2716 L. |
| Clearance | Following a single oral dose of 40 mg/kg of praziquantel in healthy volunteers, the clearance was estimated to be 11.4 ± 2.8 L/kg/h. |
Formulation & handling
- Praziquantel is an orally administered small molecule typically formulated as film‑coated tablets to mask bitterness and aid handling of its low aqueous solubility.
- Its moderate lipophilicity and poor water solubility may require particle size control or solid‑state optimization to ensure consistent oral bioavailability.
- Absorption is influenced by food intake and CYP‑mediated grapefruit interactions, which should be considered in formulation and labeling strategy.
Regulatory status
| Lifecycle | The API is in a mature phase in the US and Canadian markets, with market dynamics primarily shaped by approaching and recent patent expirations. As generic competition increases, the product’s lifecycle is characterized by stabilization rather than expansion. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Praziquantel is supplied by several established manufacturers and packagers, with the original branded product historically marketed under the name Biltricide. Branded formulations are present in the US and Canada, and the drug is widely available globally. Patent expiry occurred years ago, supporting the presence of existing generic competition in most markets. |
|---|
Safety
| Toxicity | The acute toxicity of praziquantel is relatively low, as demonstrated by oral LD<sub>50</sub> values ranging between 200 - 2976 mg/kg in various species. Published studies have not identified an association between praziquantel use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies conducted in pregnant rats and rabbits no adverse developmental outcomes were observed with oral administration of praziquantel during organogenesis at approximately 0.65 times (rats) or 1.3 times (rabbits) the highest recommended human daily dose of 75 mg/kg/day, based on body surface area. Mutagenicity studies of praziquantel published in the scientific literature are inconclusive. Long-term oral carcinogenicity studies in rats and golden hamsters did not reveal any carcinogenic effect at doses up to 250 mg/kg/day (about half of the human daily dose based on body surface area). Praziquantel had no effect on fertility and general reproductive performance of male and female rats when given at oral doses ranging from 30 to 300 mg/kg body weight (up to 0.65 times the human daily dose based on body surface area). |
|---|
- Low acute toxicity demonstrated by wide oral LD50 range (200–2976 mg/kg across species), but handling should account for species‑dependent variability in dose tolerance
- Mutagenicity findings are inconclusive
- Although long‑term studies in rodents showed no carcinogenic signal up to 250 mg/kg/day, appropriate controls for potential genotoxic risk are recommended during bulk API processing
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Praziquantel 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.
Praziquantel (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.
Praziquantel API manufacturers & distributors
Compare qualified Praziquantel API suppliers worldwide. We currently have 19 companies offering Praziquantel API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| 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, CEP, CoA, EDMF/ASMF, ISO9001, MSDS, USDMF, WC | 235 products |
| Chemo Iberica | Producer | Spain | Spain | CEP, CoA | 12 products |
| Cipla | Producer | India | India | CEP, CoA, USDMF, WC | 164 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Nanjing Pharma Factory | Producer | China | China | CEP, CoA | 1 products |
| PCAS | Producer | France | Unknown | CEP, CoA, FDA, GMP, USDMF | 29 products |
| Quimica Sintetica | Producer | Spain | Spain | CoA, GMP | 51 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Sequent Scientific | Producer | India | India | CEP, CoA, FDA | 8 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shandong Zhanhua Yonghao | Producer | China | China | CoA | 10 products |
| Shanghai Desano Chem. | Producer | China | China | CEP, CoA, FDA, GMP, USDMF | 22 products |
| Shanghai Jiayi Pharma | Producer | China | China | CEP, CoA, FDA | 1 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Shilpa Medicare Ltd | Producer | India | India | CoA, FDA, GMP | 54 products |
| Zhejiang Genebest Pharmac... | Producer | China | China | CoA | 3 products |
| Zhejiang Hisun Pharma | Producer | China | China | CEP, CoA, GMP, WC | 69 products |
When sending a request, specify which Praziquantel 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 Praziquantel 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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