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Ziprasidone | CAS No: 146939-27-7 | GMP-certified suppliers
A medication that supports management of schizophrenia and bipolar I disorder, including acute agitation episodes, offering consistent therapeutic control for diverse mental health treatment needs.
Therapeutic categories
Primary indications
- In its oral form, ziprasidone is approved for the treatment of schizophrenia, as monotherapy for acute treatment of manic or mixed episodes related to bipolar I disorder, and as adjunctive therapy to lithium or valproate for maintenance treatment of bipolar I disorder
- The injectable formulation is approved only for treatment of acute agitation in schizophrenia
Product Snapshot
- Ziprasidone is available as an oral small‑molecule capsule/suspension and as an intramuscular injectable powder for solution
- It is used for schizophrenia and bipolar I disorder, with the injectable form used for acute agitation in schizophrenia
- It is an approved API in the US and Canada
Clinical Overview
Ziprasidone exhibits antagonism at dopamine D2 and serotonin 5‑HT2A receptors, with a high 5‑HT2A to D2 affinity ratio relative to other atypical antipsychotics. It also interacts with serotonin 5‑HT1A, 5‑HT1D, and 5‑HT2C receptors and shows moderate inhibition of serotonin and norepinephrine transporters. This receptor profile contributes to antipsychotic, mood‑modulating, and anxiolytic effects, while its low affinity for muscarinic M1, histamine H1, and alpha1‑adrenergic receptors is associated with comparatively reduced risks of sedation, orthostatic hypotension, and anticholinergic burden.
Oral absorption is enhanced when taken with food. Ziprasidone is extensively metabolized, primarily via aldehyde oxidase with a smaller contribution from CYP3A4 pathways. It has a terminal elimination half‑life of roughly 7 to 10 hours, and renal excretion of unchanged drug is minimal.
Key safety considerations include dose‑dependent QTc prolongation, placing it among higher‑risk antipsychotics for this effect. Caution is warranted in patients with cardiovascular disease or when combined with other QT‑prolonging agents. As a serotonergic agent and monoamine reuptake inhibitor, it may contribute to serotonin syndrome when used with other serotonergic drugs. Metabolic adverse effects appear less frequent compared with some other atypical antipsychotics, though routine monitoring remains standard clinical practice.
For API procurement, sourcing should prioritize manufacturers with strict control of stereochemistry, impurity profiles, and particle‑size distribution to support formulation consistency and global regulatory submissions.
Identification & chemistry
| Generic name | Ziprasidone |
|---|---|
| Molecule type | Small molecule |
| CAS | 146939-27-7 |
| UNII | 6UKA5VEJ6X |
| DrugBank ID | DB00246 |
Pharmacology
| Summary | Ziprasidone is an atypical antipsychotic that primarily antagonizes 5‑HT2A and dopamine D2 receptors, with a comparatively high 5‑HT2A/D2 affinity ratio that shapes its therapeutic profile. It additionally engages multiple serotonin receptor subtypes and inhibits serotonin and norepinephrine reuptake, contributing to mood‑modulating effects. Low affinity for histamine, muscarinic, and alpha‑adrenergic receptors aligns with a reduced propensity for associated off‑target pharmacologic effects. |
|---|---|
| Mechanism of action | The effects of ziprasidone are differentiated from other antispychotics based on its preference and affinity for certain receptors. Ziprasidone binds to serotonin-2A (5-HT2A) and dopamine D2 receptors in a similar fashion to other atypical antipsychotics; however, one key difference is that ziprasidone has a higher 5-HT2A/D2 receptor affinity ratio when compared to other antipsychotics such as olanzapine, quetiapine, risperidone, and aripiprazole.Ziprasidone offers enhanced modulation of mood, notable negative symptom relief, overall cognitive improvement and reduced motor dysfunction which is linked to it's potent interaction with 5-HT2C, 5-HT1D, and 5-HT1A receptors in brain tissue.Ziprasidone can bind moderately to norepinephrine and serotonin reuptake sites which may contribute to its antidepressant and anxiolytic activity.Patient's taking ziprasidone will likely experience a lower incidence of orthostatic hypotension, cognitive disturbance, sedation, weight gain, and disruption in prolactin levels since ziprasidone has a lower affinity for histamine H1, muscarinic M1, and alpha1-adrenoceptors. |
| Pharmacodynamics | Ziprasidone is classified as a "second generation" or "atypical" antipsychotic and is a dopamine and 5HT2A receptor antagonist with a unique receptor binding profile. As previously mentioned, ziprasidone has a very high 5-HT2A/D2 affinity ratio, binds to multiple serotonin receptors in addition to 5-HT2A, and blocks monoamine transporters which prevents 5HT and NE reuptake. On the other hand, ziprasidone has a low affinity for muscarinic cholinergic M1, histamine H1, and alpha1-adrenergic receptors. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dopamine D2 receptor | Humans | antagonist |
| 5-hydroxytryptamine receptor 2A | Humans | antagonist |
| 5-hydroxytryptamine receptor 1A | Humans | agonist |
ADME / PK
| Absorption | In the absence of food, ziprasidone's oral bioavailability is 60%, and absorption may reach 100% if ziprasidone is taken with a meal containing at least 500 kcal. The difference in bioavailability has little to do with the fat content of the food and appears to be related to the bulk of the meal since more absorption occurs the longer ziprasidone remains in the stomach. |
|---|---|
| Half-life | The half life of ziprasidone is 6-7 hours. |
| Protein binding | Ziprasidone is extensively protein bound with over 99% of the drug bound to plasma proteins, primarily albumin and alpha1-acid glycoprotein. |
| Metabolism | Ziprasidone is heavily metabolized in the liver with less than 5% of the drug excreted unchanged in the urine.The primary reductive pathway is catalyzed by aldehyde oxidase, while 2 other less prominent oxidative pathways are catalyzed by CYP3A4.Ziprasidone is unlikely to interact with other medications metabolized by CYP3A4 since only 1/3 of the antipsychotic is metabolized by the CYP3A4 system. There are 12 identified ziprasidone metabolites (abbreviations italicized): Ziprasidone sulfoxide, ziprasidone sulfone, (6-chloro-2-oxo-2,3-dihydro-1H-indol-5-yl)acetic acid (_OX-COOH_), OX-COOH glucuronide, 3-(piperazine-1-yl)-1,2-benzisothiazole (_BITP_), BITP sulfoxide, BITP sulfone, BITP sulfone lactam, S-Methyl-dihydro-ziprasidone, S-Methyl-dihydro-ziprasidone-sulfoxide, 6-chloro-5-(2-piperazin-1-yl-ethyl)-1,3-dihydro-indol-2-one (_OX-P_), and dihydro-ziprasidone-sulfone. As suggested by the quantity of metabolites, ziprasidone is metabolized through several different pathways. Ziprasidone is sequentially oxidized to ziprasidone sulfoxide and ziprasidone sulfone, and oxidative N-dealkylation of ziprasidone produces OX-COOH and BITP.OX-COOH undergoes phase II metabolism to yield a glucuronidated metabolite while BITP is sequentially oxidized into BITP sulfoxide, BITP sulfone, then BITP sulfone lactam.Ziprasidone can also undergo reductive cleavage and methylation to produce S-Methyl-dihydro-ziprasidone and then further oxidation to produce S-Methyl-dihydro-ziprasidone-sulfoxide.Finally dearylation of ziprasidone produces OX-P, and the process of hydration and oxidation transforms the parent drug into dihydro-ziprasidone-sulfone. Although CYP3A4 and aldehyde oxidase are the primary enzymes involved in ziprasidone metabolism, the pathways associated with each enzyme have not been specified. |
| Route of elimination | Ziprasidone is extensively metabolized after oral administration with only a small amount excreted in the urine (<1%) or feces (<4%) as unchanged drug. |
| Volume of distribution | The mean apparent volume of distribution of Ziprasidone is 1.5 L/kg. |
| Clearance | The mean apparent systemic clearance is 7.5 mL/min/kg. |
Formulation & handling
- Oral formulations require solubility‑enhancing approaches due to low aqueous solubility and show food‑dependent absorption.
- Intramuscular products use lyophilized powder that requires controlled reconstitution to maintain stability.
- High lipophilicity (LogP ~4.3) influences excipient selection and may necessitate protective packaging to limit degradation.
Regulatory status
| Lifecycle | Most core U.S. and Canadian patents for the API expired between 2010 and 2019, indicating that key protections have fully lapsed in both markets. With the product marketed in the United States and Canada, its lifecycle aligns with a mature, post‑exclusivity stage. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Ziprasidone appears to have a single originator manufacturer, with distribution supported by numerous repackagers and secondary suppliers that broaden availability in the U.S. and Canada. Branded and non‑originator product samples indicate established global presence mainly in North America. The listed U.S. and Canadian patents expired between 2010 and 2019, consistent with existing and widespread generic competition. |
|---|
Safety
| Toxicity | The most common adverse reactions reported with ziprasidone include somnolence, respiratory tract infections, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting, headache and nausea. |
|---|
- Associated with CNS effects such as somnolence, dizziness, extrapyramidal symptoms, and akathisia, which may indicate the need for controlled handling in environments requiring operator alertness
- Reports of respiratory tract infections and gastrointestinal effects (nausea, vomiting) suggest potential for mucosal or respiratory irritation upon exposure to dust or aerosols
- Abnormal vision and headache indicate additional neuro‑sensory effects that warrant minimizing occupational exposure
Ziprasidone is a type of Atypical antipsychotics
Atypical antipsychotics belong to the subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various mental disorders, particularly schizophrenia and bipolar disorder. These medications are designed to alleviate the symptoms of psychosis by targeting specific neuroreceptors in the brain.
Unlike traditional antipsychotics, atypical antipsychotics exhibit a different pharmacological profile, providing a more favorable side effect profile and improved efficacy. These medications primarily act on dopamine and serotonin receptors, regulating the neurotransmitter levels in the brain to restore the chemical balance.
The mechanism of action of atypical antipsychotics involves blocking dopamine receptors, particularly D2 receptors, as well as modulating serotonin receptors, notably 5-HT2A receptors. By inhibiting excessive dopamine transmission and enhancing serotonin activity, atypical antipsychotics help reduce hallucinations, delusions, and other psychotic symptoms.
Some commonly used atypical antipsychotics include risperidone, olanzapine, quetiapine, and aripiprazole. These APIs are typically formulated into oral tablets or capsules for convenient administration.
Despite their effectiveness, atypical antipsychotics may have potential side effects such as weight gain, metabolic abnormalities, sedation, and extrapyramidal symptoms. Therefore, close monitoring and individualized treatment plans are essential to ensure optimal therapeutic outcomes.
In conclusion, atypical antipsychotics are a crucial subcategory of APIs used in the treatment of mental disorders. Their distinct pharmacological profile and mechanism of action make them valuable in managing psychosis while minimizing adverse effects.
Ziprasidone (Atypical antipsychotics), classified under Antipsychotics
Antipsychotics belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category used to treat psychiatric disorders such as schizophrenia, bipolar disorder, and other related conditions. These medications play a crucial role in managing symptoms associated with psychosis, including hallucinations, delusions, and disorganized thinking.
Antipsychotics work by modulating the levels of neurotransmitters in the brain, particularly dopamine and serotonin. They can be categorized into two classes: first-generation (typical) antipsychotics and second-generation (atypical) antipsychotics. Typical antipsychotics primarily target dopamine receptors, while atypical antipsychotics also affect serotonin receptors.
The pharmaceutical API category of antipsychotics includes various well-known drugs, such as haloperidol, chlorpromazine, risperidone, quetiapine, and olanzapine. These APIs are often formulated into different dosage forms, including tablets, capsules, injections, and oral suspensions, to provide flexibility in administration and patient-specific needs.
Antipsychotics offer relief from psychotic symptoms by stabilizing the imbalanced neurotransmitter activity in the brain. However, they may also have certain side effects, such as sedation, weight gain, extrapyramidal symptoms, and metabolic disturbances. It is essential for healthcare professionals to carefully monitor patients receiving antipsychotic treatment to optimize therapeutic benefits while minimizing adverse effects.
In summary, antipsychotics are a vital category of pharmaceutical APIs used to manage psychiatric disorders by modulating neurotransmitter activity in the brain. Their effectiveness in treating psychosis has made them a cornerstone of mental health treatment, providing much-needed relief to individuals suffering from these conditions.
Ziprasidone API manufacturers & distributors
Compare qualified Ziprasidone API suppliers worldwide. We currently have 9 companies offering Ziprasidone 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 |
|---|---|---|---|---|---|
| Amino Chemicals | Producer | Malta | Malta | CEP, CoA, FDA, GMP, USDMF | 20 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hetero Drugs | Producer | India | Unknown | CEP, CoA, FDA, GMP | 98 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Raks Pharma | Producer | India | India | CoA, USDMF | 58 products |
| Sun Pharma | Producer | India | India | CoA, GMP, WC | 219 products |
| Vihita Chem | Producer | India | India | CoA | 3 products |
When sending a request, specify which Ziprasidone 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 Ziprasidone 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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Technical
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