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Ondansetron | CAS No: 99614-02-5 | GMP-certified suppliers
A medication that helps prevent and treat nausea and vomiting associated with emetogenic chemotherapy, radiotherapy, and surgical procedures across appropriate adult and select pediatric populations.
Therapeutic categories
Anti-Anxiety AgentsAntidepressive AgentsAntiemetic Serotonin 5-HT3 Receptor AntagonistsAntiemeticsAntiemetics and AntinauseantsCarbazoles
Generic name
Ondansetron
Molecule type
small molecule
CAS number
99614-02-5
DrugBank ID
DB00904
Approval status
Approved drug, Withdrawn drug
ATC code
A04AA01
Primary indications
- In the adult patient population:
- I) orally administered ondansetron tablets and orally disintegrating tablets (ODT) are indicated for:
- The prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie
- Greater than or equal to 50 mg/m2) cisplatin therapy, and radiotherapy, and
Product Snapshot
- Ondansetron is an oral and parenteral small‑molecule 5‑HT3 antagonist available in tablet, ODT, injectable, and solution formats
- It is used for chemotherapy‑ and radiotherapy‑related nausea and vomiting and for postoperative nausea and vomiting in approved adult settings
- The API is approved in the US and Canada, with some product presentations withdrawn but core formulations remaining authorized
Clinical Overview
Ondansetron (CAS 99614-02-5) is a selective serotonin 5‑HT3 receptor antagonist used to prevent nausea and vomiting associated with emetogenic chemotherapy, radiotherapy, and surgical procedures. In adults, oral and orally disintegrating formulations are indicated for prevention of chemotherapy‑ and radiotherapy‑induced nausea and vomiting, and for both prevention and treatment of postoperative nausea and vomiting. Intravenous formulations are indicated for similar chemotherapy‑related uses and for postoperative nausea and vomiting. Pediatric use is limited to chemotherapy‑induced nausea and vomiting in patients 4 to 12 years of age, and the drug is not indicated for postoperative or post‑radiotherapy nausea and vomiting in any pediatric age group. Geriatric efficacy for chemotherapy‑ and radiotherapy‑related indications resembles that observed in younger adults, but the drug is not indicated for postoperative prevention or treatment in this population.
Ondansetron blocks 5‑HT3 receptors located on vagal afferents in the gastrointestinal tract and within the area postrema. Cytotoxic therapy triggers serotonin release from enterochromaffin cells, activating these pathways and initiating the vomiting reflex. By antagonizing 5‑HT3 receptors, ondansetron reduces peripheral and central emetogenic signaling.
Pharmacodynamic data demonstrate dose‑dependent QTc prolongation with intravenous administration. A 32 mg IV dose produces a mean QTcF increase of about 20 msec and is contraindicated; an 8 mg IV dose produces smaller increases. Oral dosing is predicted to have minimal QTc effect. Ondansetron does not significantly affect gastric or esophageal motility but may slow colonic transit with multiday use.
Ondansetron is metabolized primarily via CYP3A, CYP2D6, and CYP1A2, with hepatic clearance and no known prolactin effects. It is available globally in oral, orally disintegrating, injectable, and film formulations and is widely marketed as generics.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of impurities, validated processes for the carbazole‑based structure, and compliance with pharmacopeial and ICH quality standards, particularly regarding impurity profiles and stability.
Ondansetron blocks 5‑HT3 receptors located on vagal afferents in the gastrointestinal tract and within the area postrema. Cytotoxic therapy triggers serotonin release from enterochromaffin cells, activating these pathways and initiating the vomiting reflex. By antagonizing 5‑HT3 receptors, ondansetron reduces peripheral and central emetogenic signaling.
Pharmacodynamic data demonstrate dose‑dependent QTc prolongation with intravenous administration. A 32 mg IV dose produces a mean QTcF increase of about 20 msec and is contraindicated; an 8 mg IV dose produces smaller increases. Oral dosing is predicted to have minimal QTc effect. Ondansetron does not significantly affect gastric or esophageal motility but may slow colonic transit with multiday use.
Ondansetron is metabolized primarily via CYP3A, CYP2D6, and CYP1A2, with hepatic clearance and no known prolactin effects. It is available globally in oral, orally disintegrating, injectable, and film formulations and is widely marketed as generics.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of impurities, validated processes for the carbazole‑based structure, and compliance with pharmacopeial and ICH quality standards, particularly regarding impurity profiles and stability.
Identification & chemistry
| Generic name | Ondansetron |
|---|---|
| Molecule type | Small molecule |
| CAS | 99614-02-5 |
| UNII | 4AF302ESOS |
| DrugBank ID | DB00904 |
Pharmacology
| Summary | Ondansetron is a selective 5‑HT3 receptor antagonist that blocks serotonin‑mediated activation of vagal afferents in the gut and the chemoreceptor trigger zone. By inhibiting these peripheral and central 5‑HT3 signaling pathways, it reduces the neural input that initiates nausea and vomiting triggered by chemotherapy, radiotherapy, or surgical stimuli. Its pharmacodynamic profile is highly specific to 5‑HT3 receptors, with minimal activity at other serotonin or dopamine receptors. |
|---|---|
| Mechanism of action | Ondansetron is a selective antagonist of the serotonin receptor subtype, 5-HT3 . Cytotoxic chemotherapy and radiotherapy are associated with the release of serotonin (5-HT) from enterochromaffin cells of the small intestine, presumably initiating a vomiting reflex through stimulation of 5-HT3 receptors located on vagal afferents . Ondansetron may block the initiation of this reflex. Activation of vagal afferents may also cause a central release of serotonin from the chemoreceptor trigger zone of the area postrema, located on the floor of the fourth ventricle . Thus, the antiemetic effect of ondansetron is probably due to the selective antagonism of 5-HT3 receptors on neurons located in either the peripheral or central nervous systems, or both . Although the mechanisms of action of ondansetron in treating postoperative nausea and vomiting and cytotoxic induced nausea and vomiting may share similar pathways, the role of ondansetron in opiate-induced emesis has not yet been formally established . |
| Pharmacodynamics | Ondansetron is a highly specific and selective serotonin 5-HT<sub>3</sub> receptor antagonist, not shown to have activity at other known serotonin receptors and with low affinity for dopamine receptors [FDA Label], . The serotonin 5-HT<sub>3</sub> receptors are located on the nerve terminals of the vagus in the periphery, and centrally in the chemoreceptor trigger zone of the area postrema [FDA Label], . The temporal relationship between the emetogenic action of emetogenic drugs and the release of serotonin, as well as the efficacy of antiemetic agents, suggest that chemotherapeutic agents release serotonin from the enterochromaffin cells of the small intestine by causing degenerative changes in the GI tract [FDA Label], . The serotonin then stimulates the vagal and splanchnic nerve receptors that project to the medullary vomiting center, as well as the 5-HT<sub>3</sub> receptors in the area postrema, thus initiating the vomiting reflex, causing nausea and vomiting [FDA Label], . Moreover, the effect of ondansetron on the QTc interval was evaluated in a double-blind, randomized, placebo and positive (moxifloxacin) controlled, crossover study in 58 healthy adult men and women . Ondansetron was tested at single doses of 8 mg and 32 mg infused intravenously over 15 minutes . At the highest tested dose of 32 mg, prolongation of the Fridericia-corrected QTc interval (QT/RR0.33=QTcF) was observed from 15 min to 4 h after the start of the 15 min infusion, with a maximum mean (upper limit of 90% CI) difference in QTcF from placebo after baseline-correction of 19.6 (21.5) msec at 20 min . At the lower tested dose of 8 mg, QTc prolongation was observed from 15 min to 1 h after the start of the 15-minute infusion, with a maximum mean (upper limit of 90% CI) difference in QTcF from placebo after baseline-correction of 5.8 (7.8) msec at 15 min . The magnitude of QTc prolongation with ondansetron is expected to be greater if the infusion rate is faster than 15 minutes . The 32 mg intravenous dose of ondansetron must not be administered . No treatment-related effects on the QRS duration or the PR interval were observed at either the 8 or 32 mg dose . An ECG assessment study has not been performed for orally administered ondansetron . On the basis of pharmacokinetic-pharmacodynamic modelling, an 8 mg oral dose of ondansetron is predicted to cause a mean QTcF increase of 0.7 ms (90% CI -2.1, 3.3) at steady-state, assuming a mean maximal plasma concentration of 24.7 ng/mL (95% CI 21.1, 29.0) . The magnitude of QTc prolongation at the recommended 5 mg/m2 dose in pediatrics has not been studied, but pharmacokinetic-pharmacodynamic modeling predicts a mean increase of 6.6 ms (90% CI 2.8, 10.7) at maximal plasma concentrations . In healthy subjects, single intravenous doses of 0.15 mg/kg of ondansetron had no effect on esophageal motility, gastric motility, lower esophageal sphincter pressure, or small intestinal transit time . Multiday administration of ondansetron has been shown to slow colonic transit in healthy subjects . Ondansetron has no effect on plasma prolactin concentrations . |
Targets
| Target | Organism | Actions |
|---|---|---|
| 5-hydroxytryptamine receptor 3A | Humans | antagonist |
| 5-hydroxytryptamine receptor 4 | Humans | agonist |
| Mu-type opioid receptor | Humans | other/unknown |
ADME / PK
| Absorption | Ondansetron is absorbed from the gastrointestinal tract and undergoes some limited first-pass metabolism . Mean bioavailability in healthy subjects, following administration of a single 8-mg tablet, was recorded as being approximately 56% to 60% . Bioavailability is also slightly enhanced by the presence of food . Ondansetron systemic exposure does not increase proportionately to dose . The AUC from a 16-mg tablet was 24% greater than predicted from an 8-mg tablet dose . This may reflect some reduction of first-pass metabolism at higher oral doses . |
|---|---|
| Half-life | The half-life of ondansetron after either an 8 mg oral dose or intravenous dose was approximately 3-4 hours and could be extended to 6-8 hours in the elderly . |
| Protein binding | The plasma protein binding associated with ondansetron was documented as approximately 73% . |
| Metabolism | In vitro metabolism studies have shown that ondansetron is a substrate for human hepatic cytochrome P450 enzymes, including CYP1A2, CYP2D6 and CYP3A4 . In terms of overall ondansetron turnover, CYP3A4 played the predominant role . Because of the multiplicity of metabolic enzymes capable of metabolizing ondansetron, it is likely that inhibition or loss of one enzyme (e.g. CYP2D6 enzyme deficiency) will be compensated by others and may result in little change in overall rates of ondansetron clearance . Following oral or IV administration, ondansetron is extensively metabolised and excreted in the urine and faeces . In humans, less than 10% of the dose is excreted unchanged in the urine . The major urinary metabolites are glucuronide conjugates (45%), sulphate conjugates (20%) and hydroxylation products (10%) . The primary metabolic pathway is subsequently hydroxylation on the indole ring followed by subsequent glucuronide or sulfate conjugation . Although some nonconjugated metabolites have pharmacologic activity, these are not found in plasma at concentrations likely to significantly contribute to the biological activity of ondansetron . |
| Route of elimination | Following oral or IV administration, ondansetron is extensively metabolised and excreted in the urine and faeces . |
| Volume of distribution | The volume of distribution of ondansetron has been recorded as being approximately 160L . |
| Clearance | The clearance values determined for ondansetron in various patient age groups were recorded as approximately 0.38 L/h/kg in normal adult volunteers aged 19-40 yrs, 0.32 L/h/kg in normal adult volunteers aged 61-74 yrs, 0.26 L/h/kg in normal adult volunteers aged >=75 yrs [FDA Label]. |
Formulation & handling
- Oral formulations are straightforward due to food‑independent absorption and moderate lipophilicity, but low aqueous solubility may require solubilizers or dispersion strategies.
- Parenteral products use aqueous solutions where the solid API’s limited water solubility necessitates pH adjustment and cosolvent/control of precipitation during manufacture and storage.
- ODT, soluble film, and sublingual formats rely on rapid disintegration and wetting; the chemically stable small‑molecule API generally tolerates standard excipients and ambient‑temperature handling.
Regulatory status
| Lifecycle | Key patent protections in the United States expired between 2011 and 2016, with the corresponding Canadian patent expiring in 2015, indicating that the API is in a mature post‑exclusivity phase. With products marketed in both the US and Canada, the market is consistent with widespread generic availability. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Ondansetron was originally developed by a single originator company, after which a large number of manufacturers and packagers now supply the active ingredient and finished dosage forms. Branded and generic products are widely available in the US and Canada, with limited brand differentiation as most markets rely on generic versions. All listed patents have expired, indicating that generic competition is well‑established. |
|---|
Safety
| Toxicity | At present, there is little information concerning overdosage with ondansetron . Nevertheless, there have been certain cases of somewhat idiosyncratic adverse effects associated with particular dosages of ondansetron used . “Sudden blindness” (amaurosis) of 2 to 3 minutes duration plus severe constipation occurred in one patient that was administered 72 mg of ondansetron intravenously as a single dose . Hypotension (and faintness) occurred in another patient that took 48 mg of oral ondansetron . Following infusion of 32 mg over only a 4-minute period, a vasovagal episode with transient second-degree heart block was observed . Neuromuscular abnormalities, autonomic instability, somnolence, and a brief generalized tonic-clonic seizure (which resolved after a dose of benzodiazepine) were observed in a 12-month-old infant who ingested seven or eight 8-mg ondansetron tablets (approximately forty times the recommended 0.1-0.15 mg/kg dose for a pediatric patient) . In all instances, however, the events resolved completely . The safety of ondansetron for use in human pregnancy has not been established . Ondansetron is not teratogenic in animals . However, as animal studies are not always predictive of human response, the use of ondansetron in pregnancy is not recommended . Ondansetron is excreted in the milk of lactating rats . It is not known if it is excreted in human milk, however, nursing is not recommended during treatment with ondansetron . Insufficient information is available to provide dosage recommendations for children 3 years of age or younger . |
|---|
High Level Warnings:
- High-dose exposure has been associated with transient neurological and cardiovascular events, including brief amaurosis, hypotension, vasovagal episodes, and conduction abnormalities
- Significant overdoses have produced neuromuscular and autonomic instability in pediatric cases
- Events resolved but indicate toxicity risk at large multiples of therapeutic exposure
Ondansetron is a type of 5HT3 antagonists
5HT3 antagonists are a subcategory of pharmaceutical APIs that play a crucial role in managing various conditions related to the serotonin neurotransmitter system. Serotonin, also known as 5-hydroxytryptamine (5HT), is a neurotransmitter that regulates various physiological functions, including mood, appetite, and gastrointestinal motility.
The 5HT3 antagonists work by selectively blocking the serotonin type 3 receptors in the central and peripheral nervous systems. By doing so, they inhibit the binding of serotonin to these receptors, thereby reducing its effects. This mechanism of action makes them effective in treating conditions such as chemotherapy-induced nausea and vomiting, post-operative nausea and vomiting, and irritable bowel syndrome.
One of the commonly used 5HT3 antagonists is ondansetron, which is available in oral and injectable forms. It is widely prescribed to cancer patients undergoing chemotherapy to alleviate the distressing side effects of nausea and vomiting. Other notable 5HT3 antagonists include granisetron, palonosetron, and dolasetron.
These pharmaceutical APIs offer several advantages, including high selectivity for the 5HT3 receptors, rapid onset of action, and a favorable safety profile. They are typically well-tolerated by patients, with minimal adverse effects. However, healthcare professionals must consider individual patient factors and potential drug interactions when prescribing these medications.
In summary, 5HT3 antagonists are an important subcategory of pharmaceutical APIs that provide effective relief from nausea and vomiting associated with various medical conditions. Their targeted mechanism of action and favorable safety profile make them valuable tools in the management of these symptoms, benefiting patients and improving their overall quality of life.
Ondansetron (5HT3 antagonists), classified under Antiemetics
Antiemetics are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) used to alleviate and prevent nausea and vomiting, also known as emesis. They play a vital role in managing these distressing symptoms, which can be caused by various factors such as chemotherapy, postoperative recovery, motion sickness, or gastrointestinal disorders.
Antiemetics work by targeting specific pathways in the body that trigger emesis. One common mechanism involves blocking dopamine receptors in the brain, as dopamine plays a significant role in triggering the vomiting reflex. This class of antiemetics is known as dopamine antagonists. Another mechanism involves inhibiting serotonin receptors, which are associated with nausea and vomiting. These agents, called serotonin antagonists, effectively reduce these symptoms.
In addition to dopamine and serotonin antagonists, other types of antiemetics include neurokinin-1 receptor antagonists, antihistamines, and anticholinergics. Each of these classes acts on different pathways in the body to provide relief from nausea and vomiting.
Pharmaceutical companies manufacture antiemetic APIs in accordance with strict quality control guidelines and regulations. These APIs serve as the active ingredients in various formulations, such as tablets, capsules, injections, or suppositories, designed to deliver the desired therapeutic effects.
Overall, antiemetic APIs form an essential category in the pharmaceutical industry, addressing the significant need for effective management of nausea and vomiting. Their development and availability greatly contribute to enhancing patient comfort and quality of life during various medical treatments and conditions.
Ondansetron API manufacturers & distributors
Compare qualified Ondansetron API suppliers worldwide. We currently have 16 companies offering Ondansetron 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 |
|---|---|---|---|---|---|
| Cipla | Producer | India | Unknown | CEP, CoA, KDMF, USDMF, WC | 164 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Dr. Sahu's Laboratories | Producer | India | India | CoA, GMP | 70 products |
| Gedeon Richter | Producer | Hungary | Unknown | CEP, CoA, FDA, GMP | 48 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hikal | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 26 products |
| Ipca Labs. | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 69 products |
| Lorem | Producer | Spain | Spain | BSE/TSE, CoA, GDP, GMP, ISO9001, MSDS, USDMF | 1 products |
| Natco Pharma | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 40 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sun Pharma | Producer | India | India | CEP, CoA, USDMF, WC | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
When sending a request, specify which Ondansetron 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 Ondansetron 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 Ondansetron API
Sourcing
What matters most when sourcing GMP-grade Ondansetron?
Key considerations include confirming compliance with GMP standards and applicable regulatory requirements in the US and Canada. Suppliers should provide clear evidence of regulatory status and quality controls suitable for an established generic API. Because patents have expired and many manufacturers exist, verifying consistency of manufacturing practices and documentation is important when selecting among multiple generic sources.
Which documents are typically required when sourcing Ondansetron API?
Request the core API documentation set: CoA (15 companies), GMP (11 companies), FDA (8 companies), USDMF (7 companies), CEP (6 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Ondansetron API?
Known or reported manufacturers for Ondansetron: Tresinde Biotech, Global Pharma Tek, SETV Global, Tenatra Exports Private Limited, Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Ondansetron API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Ondansetron manufacturers?
Audit reports may be requested for Ondansetron: 5 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Ondansetron API on Pharmaoffer?
Reported supplier count for Ondansetron: 15 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Ondansetron API?
Production countries reported for Ondansetron: India (11 producers), Spain (1 producer), China (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Ondansetron usually hold?
Common certifications for Ondansetron suppliers: CoA (15 companies), GMP (11 companies), FDA (8 companies), USDMF (7 companies), CEP (6 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Ondansetron (CAS 99614-02-5) used for?
Ondansetron is used to prevent nausea and vomiting associated with emetogenic chemotherapy, radiotherapy, and surgical procedures. In adults, it is indicated for chemotherapy‑ and radiotherapy‑induced nausea and vomiting and for prevention and treatment of postoperative nausea and vomiting. In children 4 to 12 years of age, its use is limited to chemotherapy‑induced nausea and vomiting.
Which therapeutic class does Ondansetron fall into?
Ondansetron belongs to the following therapeutic categories: Anti-Anxiety Agents, Antidepressive Agents, Antiemetic Serotonin 5-HT3 Receptor Antagonists, Antiemetics, Antiemetics and Antinauseants. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Ondansetron mainly prescribed for?
The primary indications for Ondansetron: In the adult patient population:, I) orally administered Ondansetron tablets and orally disintegrating tablets (ODT) are indicated for:, The prevention of nausea and vomiting associated with emetogenic cancer chemotherapy, including high dose (ie, Greater than or equal to 50 mg/m2) cisplatin therapy, and radiotherapy, and. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Ondansetron work?
Ondansetron is a selective antagonist of the serotonin receptor subtype, 5-HT3 .
Cytotoxic chemotherapy and radiotherapy are associated with the release of serotonin (5-HT) from enterochromaffin cells of the small intestine, presumably initiating a vomiting reflex through stimulation of 5-HT3 receptors located on vagal afferents . Ondansetron may block the initiation of this reflex. Activation of vagal afferents may also cause a central release of serotonin from the chemoreceptor trigger zone of the area postrema, located on the floor of the fourth ventricle . Thus, the antiemetic effect of Ondansetron is probably due to the selective antagonism of 5-HT3 receptors on neurons located in either the peripheral or central nervous systems, or both .
Although the mechanisms of action of Ondansetron in treating postoperative nausea and vomiting and cytotoxic induced nausea and vomiting may share similar pathways, the role of Ondansetron in opiate-induced emesis has not yet been formally established .
What should someone know about the safety or toxicity profile of Ondansetron?
Ondansetron can produce dose‑dependent cardiovascular effects, including QTc prolongation with intravenous use, with a 32 mg IV dose contraindicated due to a mean QTcF increase of about 20 msec. High‑dose or overdose exposure has been associated with transient neurological and cardiovascular events such as brief amaurosis, hypotension, vasovagal episodes, conduction abnormalities, and, in pediatric cases, neuromuscular and autonomic instability. These events resolved but indicate toxicity risk at large multiples of therapeutic exposure. Oral dosing is predicted to have minimal QTc effect.
What are important formulation and handling considerations for Ondansetron as an API?
Ondansetron’s low aqueous solubility requires use of solubilizers, pH adjustment, or dispersion techniques in both oral and parenteral formulations to prevent precipitation. For orally disintegrating, soluble film, or sublingual forms, rapid wetting and disintegration are key, and the API is compatible with common excipients. Parenteral solutions need controlled pH and appropriate cosolvent systems to maintain solubility during manufacture and storage. The API is chemically stable and can generally be handled under standard ambient conditions.
Is Ondansetron a small molecule?
Ondansetron is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Ondansetron?
Oral Ondansetron has no unusual stability issues beyond those typical for small‑molecule solid oral products. The API is chemically stable and generally compatible with standard excipients, and oral tablets, ODTs, and films tolerate ambient‑temperature handling. The main formulation consideration is its low aqueous solubility, which may require solubilizers or dispersion approaches but does not pose a specific stability liability.
Regulatory
Where is Ondansetron approved or in use globally?
Ondansetron is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Ondansetron procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Ondansetron. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Ondansetron included in the PRO Data Insights coverage?
PRO Data Insights coverage for Ondansetron: 5217 verified transactions across 1255 suppliers and 494 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Ondansetron?
Market report availability for Ondansetron: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
