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Domperidone | CAS No: 57808-66-9 | GMP-certified suppliers
A medication that supports management of dyspepsia, heartburn, epigastric discomfort, and helps reduce nausea and vomiting for gastrointestinal symptom relief.
Therapeutic categories
Primary indications
- For management of dyspepsia, heartburn, epigastric pain, nausea, and vomiting
Product Snapshot
- Domperidone is available as an oral small‑molecule formulation with multiple solid and liquid presentations, and also in parenteral and rectal dosage forms
- It is used for management of dyspepsia, heartburn, epigastric discomfort, nausea, and vomiting
- It is approved in Canada with additional investigational and veterinary approval statuses in other markets
Clinical Overview
Domperidone’s pharmacology is characterized by selective antagonism of dopamine receptors outside the blood–brain barrier. By blocking peripheral D2 receptors, it increases esophageal and gastric peristalsis, lowers esophageal sphincter pressure, and accelerates gastric emptying. The compound reduces small bowel transit time, supporting use in functional motility disorders. Its antiemetic effect arises from inhibition of dopamine-mediated signaling at the chemoreceptor trigger zone and at gastric sites involved in emetic reflex activation.
Absorption is variable and influenced by gastric pH and motility. Domperidone is extensively metabolized, predominantly via CYP3A enzymes, with contributions from other cytochrome P450 pathways. It is also a P‑glycoprotein substrate. Protein binding is high, and the compound exhibits limited penetration into the central nervous system. Elimination occurs mainly through hepatic metabolism. Specific quantitative ADME parameters differ by population and formulation and should be confirmed from primary regulatory sources.
Safety considerations include dose- and concentration‑dependent QTc prolongation, with increased risk in the presence of strong CYP3A inhibitors, underlying cardiac disease, electrolyte disturbances, or excessive systemic exposure. Elevated prolactin levels can occur due to dopamine receptor blockade. The agent has been used in human and veterinary contexts, but regulatory status and permitted indications vary globally.
Common branded oral formulations have been available in multiple regions, though market presence differs by jurisdiction.
For API procurement, suppliers should provide evidence of compliance with pharmacopoeial specifications, control of residual solvents, and characterization of polymorphic form. Verification of impurity profiles and assessment of GMP adherence are essential for formulation development and regulatory submissions.
Identification & chemistry
| Generic name | Domperidone |
|---|---|
| Molecule type | Small molecule |
| CAS | 57808-66-9 |
| UNII | 5587267Z69 |
| DrugBank ID | DB01184 |
Pharmacology
| Summary | Domperidone is a peripheral dopamine D2/D3 receptor antagonist that enhances gastrointestinal motility by increasing esophageal and gastric peristalsis and accelerating gastric emptying. Its blockade of dopamine receptors in the chemoreceptor trigger zone and gastrointestinal tract contributes to its antiemetic effects. The drug also influences endocrine pathways by promoting prolactin release. |
|---|---|
| Mechanism of action | Domperidone acts as a gastrointestinal emptying (delayed) adjunct and peristaltic stimulant. The gastroprokinetic properties of domperidone are related to its peripheral dopamine receptor blocking properties. Domperidone facilitates gastric emptying and decreases small bowel transit time by increasing esophageal and gastric peristalsis and by lowering esophageal sphincter pressure. Antiemetic: The antiemetic properties of domperidone are related to its dopamine receptor blocking activity at both the chemoreceptor trigger zone and at the gastric level. It has strong affinities for the D2 and D3 dopamine receptors, which are found in the chemoreceptor trigger zone, located just outside the blood brain barrier, which - among others - regulates nausea and vomiting |
| Pharmacodynamics | Domperidone is a specific blocker of dopamine receptors. It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dopamine D3 receptor | Humans | antagonist |
| Dopamine D2 receptor | Humans | antagonist |
ADME / PK
| Half-life | 7 hours |
|---|---|
| Protein binding | 91%-93% |
Formulation & handling
- Domperidone is a small‑molecule benzimidazole with low aqueous solubility, supporting solid oral forms that may require solubilizers or wet‑granulation approaches for consistent dissolution.
- Parenteral formulations benefit from its moderate lipophilicity and require solubilizing excipients to maintain clarity and stability in aqueous injection vehicles.
- Oral products may require attention to food‑related variability in absorption and should control particle size and dissolution rate to minimize food‑dependent pharmacokinetic shifts.
Regulatory status
| Lifecycle | In Canada, the API’s lifecycle maturity will depend on its specific patent expiry timing; once patents lapse, the market typically shifts toward a stable, generic‑driven phase. This places the product in a lifecycle stage defined primarily by local patent status rather than geographic expansion. |
|---|
| Markets | Canada |
|---|
Supply Chain
| Supply chain summary | Domperidone was developed by an originator company decades ago, and all key patents have long expired, resulting in a market supplied almost entirely by generic manufacturers. Branded and non‑branded generics are widely available in markets such as Canada and many regions outside the United States, where the product is not formally approved. The mature patent status supports continued broad generic competition in global supply channels. |
|---|
Safety
| Toxicity | Side effects include galactorrhea, gynecomastia, or menstrual irregularities. |
|---|
- Compound can induce endocrine‑related effects (galactorrhea, gynecomastia, menstrual cycle disruption)
- Avoid inhalation or dermal exposure and implement controls to limit occupational contact
- Handle in ventilated containment due to potential dopaminergic pathway interference and associated hormonal perturbation at low exposure thresholds
Domperidone is a type of Prokinetics
Prokinetics are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the field of gastrointestinal (GI) disorders. These medications are designed to enhance the motility of the GI tract, specifically the muscles involved in digestion and the movement of food.
Prokinetics work by stimulating the release of acetylcholine, a neurotransmitter that promotes muscle contractions. By increasing the muscular contractions, prokinetics accelerate the movement of food through the GI tract, facilitating efficient digestion and absorption of nutrients. This can be beneficial in conditions such as gastroesophageal reflux disease (GERD), gastroparesis, and functional dyspepsia.
One common prokinetic API is metoclopramide, which acts by blocking dopamine receptors in the brain and enhancing motility in the upper GI tract. Another widely used prokinetic is domperidone, which primarily works by blocking dopamine receptors in the gut. These medications are available in various formulations, including tablets, capsules, and suspensions.
Prokinetics can offer relief to patients suffering from GI disorders by alleviating symptoms like nausea, vomiting, bloating, and heartburn. However, it is important to note that these medications should be used under the guidance of healthcare professionals, as they may have potential side effects and drug interactions.
In conclusion, prokinetics are a valuable subcategory of pharmaceutical APIs used in the treatment of GI disorders. By enhancing GI motility, these medications promote proper digestion and provide relief from symptoms associated with impaired gut function. Consultation with a healthcare provider is essential to ensure safe and effective use of prokinetics.
Domperidone (Prokinetics), classified under Gastrointestinal Agents
Gastrointestinal Agents belong to the pharmaceutical API category that focuses on treating disorders and ailments related to the digestive system. These agents play a crucial role in addressing various gastrointestinal conditions, such as acid reflux, ulcers, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD).
One of the key types of gastrointestinal agents is proton pump inhibitors (PPIs), which work by reducing the production of stomach acid. PPIs help in treating conditions like gastroesophageal reflux disease (GERD) and peptic ulcers. Another essential class of agents is antacids, which neutralize excessive stomach acid, providing relief from heartburn and indigestion.
Gastrointestinal agents also include antispasmodics that alleviate abdominal cramps and spasms associated with conditions like IBS. These drugs work by relaxing the smooth muscles of the digestive tract. Additionally, there are drugs categorized as laxatives that aid in relieving constipation by promoting bowel movements.
Moreover, certain gastrointestinal agents act as antiemetics, effectively reducing nausea and vomiting. These drugs are particularly useful for patients undergoing chemotherapy or experiencing motion sickness.
Pharmaceutical companies develop and manufacture a wide range of gastrointestinal agents in various forms, including tablets, capsules, suspensions, and injections. These agents are typically formulated using active pharmaceutical ingredients (APIs) and other excipients to ensure their efficacy and safety.
In conclusion, gastrointestinal agents form a vital category of pharmaceutical APIs, providing relief from digestive disorders and improving overall gastrointestinal health. The availability of diverse agents catering to different conditions ensures that patients can receive targeted treatment for their specific gastrointestinal needs.
Domperidone API manufacturers & distributors
Compare qualified Domperidone API suppliers worldwide. We currently have 8 companies offering Domperidone API, with manufacturing taking place in 3 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 |
| Derivados Quimicos | Producer | Spain | Spain | CoA, GMP, JDMF | 18 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hari Ganesh Pharma Privat... | Distributor | India | India | CoA, FDA, GMP, USDMF | 35 products |
| Janssen Pharma | Producer | Belgium | Unknown | CEP, CoA, GMP | 63 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Vasudha Pharma Chem Ltd. | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, KDMF, MSDS, USDMF, WC | 37 products |
When sending a request, specify which Domperidone 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 Domperidone 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 Domperidone API
Sourcing
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Technical
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Regulatory
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