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Loperamide | CAS No: 53179-11-6 | GMP-certified suppliers
A medication that provides symptomatic relief of acute, chronic, and travelers’ diarrhea, including support for managing chemotherapy‑related episodes in diverse clinical settings.
Therapeutic categories
Agents causing hyperkalemiaAlimentary Tract and MetabolismAntiarrhythmic agentsAntidiarrhealsAntidiarrheals, Intestinal Antiinflammatory/antiinfective AgentsAntipropulsives
Generic name
Loperamide
Molecule type
small molecule
CAS number
53179-11-6
DrugBank ID
DB00836
Approval status
Approved drug
ATC code
A07DA53
Primary indications
- Loperamide is indicated for the relief of diarrhea, including Travelers’ Diarrhea
- As an off-label use, it is often used to manage chemotherapy-related diarrhea
Product Snapshot
- Loperamide is an oral small‑molecule antidiarrheal available mainly as tablets, capsules, and oral liquids
- It is used for symptomatic management of acute and chronic diarrhea, including traveler’s diarrhea, with additional off‑label use in chemotherapy‑related diarrhea
- It is approved in major North American markets, including the US and Canada
Clinical Overview
Loperamide (CAS 53179‑11‑6) is an orally administered antidiarrheal agent indicated for the symptomatic control of acute and chronic diarrhea, including Travelers’ Diarrhea. It is also used off‑label to manage chemotherapy‑related diarrhea when non‑pharmacologic measures are insufficient. The molecule is a highly lipophilic synthetic phenylpiperidine opioid in the diphenylmethane class.
Loperamide acts as a potent peripheral mu‑opioid receptor agonist located on intestinal circular and longitudinal smooth muscle. Receptor engagement initiates G‑protein–mediated signaling that suppresses excitatory and inhibitory enteric nerve activity. This inhibition reduces acetylcholine and prostaglandin release, diminishes propulsive peristalsis, prolongs colonic transit time, and increases fluid and electrolyte absorption. Enhanced rectal tone and increased anal sphincter tone contribute to reduced urgency and incontinence. Onset of effect occurs within about one hour and the pharmacodynamic influence may persist for up to three days.
Therapeutic concentrations remain largely peripheral because P‑glycoprotein–mediated efflux at the blood‑brain barrier restricts central nervous system penetration. However, supratherapeutic exposures or P‑glycoprotein inhibition may permit central opioid effects. The compound is a substrate for several cytochrome P450 isoenzymes, but detailed quantitative pharmacokinetic parameters are not provided in this dataset.
Safety concerns are primarily dose related. Extremely high plasma concentrations can interfere with cardiac conduction through inhibition of sodium channels and hERG potassium channels, leading to QRS and QTc prolongation. Reported outcomes include ventricular dysrhythmias, torsade de pointes, ventricular fibrillation, and cardiac arrest. Misuse for euphoric effects or self‑management of opioid withdrawal has been associated with life‑threatening toxicity.
Loperamide is widely available in over‑the‑counter antidiarrheal products internationally. Reference brands vary by region but commonly include immediate‑release oral solid and liquid formulations.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of impurities, consistent polymorphic form, and validated processes for residual solvent and potency specifications to support global regulatory submissions and robust formulation performance.
Loperamide acts as a potent peripheral mu‑opioid receptor agonist located on intestinal circular and longitudinal smooth muscle. Receptor engagement initiates G‑protein–mediated signaling that suppresses excitatory and inhibitory enteric nerve activity. This inhibition reduces acetylcholine and prostaglandin release, diminishes propulsive peristalsis, prolongs colonic transit time, and increases fluid and electrolyte absorption. Enhanced rectal tone and increased anal sphincter tone contribute to reduced urgency and incontinence. Onset of effect occurs within about one hour and the pharmacodynamic influence may persist for up to three days.
Therapeutic concentrations remain largely peripheral because P‑glycoprotein–mediated efflux at the blood‑brain barrier restricts central nervous system penetration. However, supratherapeutic exposures or P‑glycoprotein inhibition may permit central opioid effects. The compound is a substrate for several cytochrome P450 isoenzymes, but detailed quantitative pharmacokinetic parameters are not provided in this dataset.
Safety concerns are primarily dose related. Extremely high plasma concentrations can interfere with cardiac conduction through inhibition of sodium channels and hERG potassium channels, leading to QRS and QTc prolongation. Reported outcomes include ventricular dysrhythmias, torsade de pointes, ventricular fibrillation, and cardiac arrest. Misuse for euphoric effects or self‑management of opioid withdrawal has been associated with life‑threatening toxicity.
Loperamide is widely available in over‑the‑counter antidiarrheal products internationally. Reference brands vary by region but commonly include immediate‑release oral solid and liquid formulations.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of impurities, consistent polymorphic form, and validated processes for residual solvent and potency specifications to support global regulatory submissions and robust formulation performance.
Identification & chemistry
| Generic name | Loperamide |
|---|---|
| Molecule type | Small molecule |
| CAS | 53179-11-6 |
| UNII | 6X9OC3H4II |
| DrugBank ID | DB00836 |
Pharmacology
| Summary | Loperamide is a peripherally acting mu‑opioid receptor agonist that suppresses enteric neuronal excitability, reducing neurotransmitter release and gastrointestinal motility. Its activity decreases peristalsis and fluid secretion while enhancing water and electrolyte absorption, producing its antidiarrheal effect. At high systemic concentrations, it can interact with cardiac ion channels and, if efflux transport is saturated, may access central opioid sites. |
|---|---|
| Mechanism of action | Enteric neurons synthesize and release endogenous opioid peptides and other neurotransmitters, such as acetylcholine and substance P. Endogenous opioids bind to opioid receptors expressed on these neurons to regulate gastrointestinal signalling, motility, and balance of fluids and electrolytes. Loperamide acts on the mu-opioid receptor expressed on the circular and longitudinal intestinal muscle.Receptor binding leads to the recruitment of G-protein receptor kinases and the activation of downstream molecular cascades that inhibit enteric nerve activity.By inhibiting the excitability of enteric neurons, loperamide suppresses neurotransmitter release, pre-synaptic and post-synaptic inhibition of transmission of excitatory and inhibitory motor pathways, and secretomotor pathways.Loperamide inhibits the release of acetylcholine and prostaglandins,thereby reducing propulsive peristalsis and increasing intestinal transit time.Loperamide stimulates the intestinal absorption of water and electrolytes by inhibiting calmodulin.Loperamide can bind to and hyperpolarize submucosal secretomotor neurons, promoting dry, hard stools. |
| Pharmacodynamics | Loperamide is an anti-diarrheal agent that provides symptomatic relief of diarrhea.It decreases peristalsis and fluid secretion in the gastrointestinal tract, delays colonic transit time, and increases the absorption of fluids and electrolytes from the gastrointestinal tract.Loperamide also increases rectal tone,reduces daily fecal volume, and increases the viscosity and bulk density of feces.It also increases the tone of the anal sphincter, thereby reducing incontinence and urgency.The onset of action is about one hour and the duration of action can be up to three days. While loperamide is a potent mu-opioid receptor agonist,it does not mediate significant analgesic activity at therapeutic and supratherapeutic doses.However, at high doses of loperamide, inhibition of P-glycoprotein-mediated drug efflux may allow loperamide to cross the blood-brain barrier, where loperamide can exert central opioid effects and toxicity. At very high plasma concentrations, loperamide can interfere with cardiac conduction.Because loperamide inhibits the Na<sup>+</sup>-gated cardiac channels and ether-a-go-go–related gene potassium channels,the drug can prolong the QRS complex and the QTc interval, which can lead to ventricular dysrhythmias, monomorphic and polymorphic ventricular tachycardia, torsade de pointes, ventricular fibrillation, Brugada syndrome, cardiac arrest, and death. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Mu-type opioid receptor | Humans | agonist |
| Delta-type opioid receptor | Humans | agonist |
| Kappa-type opioid receptor | Humans | agonist |
ADME / PK
| Absorption | Loperamide is well absorbed from the gastrointestinal tract; however, it undergoes extensive first-pass metabolism to form metabolites that are excreted in the bile. Therefore, little loperamide actually reaches the systemic circulation.The drug bioavailability is less than 1%. Following oral administration of a 2 mg capsule of loperamide, plasma concentrations of unchanged drug were below 2 ng/mL. Plasma loperamide concentrations are highest approximately five hours after administration of an oral capsule of loperamide and 2.5 hours after the liquid formulation of the drug. |
|---|---|
| Half-life | The apparent elimination half-life of loperamide is 10.8 hours with a range of 9.1 to 14.4 hours. |
| Protein binding | Based on literature information, the plasma protein binding of loperamide is about 95%. |
| Metabolism | Loperamide is extensively metabolized. The primary metabolic pathway is oxidative N-demethylation mediated by CYP2C8 and CYP3A4, to form N-demethyl loperamide. CYP2B6 and CYP2D6 play a minor role in loperamide N-demethylation.Metabolites of loperamide are pharmacologically inactive. |
| Route of elimination | Loperamide and its metabolites in the systemic circulation undergo biliary excretion.Excretion of the unchanged loperamide and its metabolites mainly occurs through the feces.Only 1% of an absorbed dose excreted unchanged in the urine. |
| Volume of distribution | Loperamide has a large volume of distribution.Although highly lipophilic, loperamide does not cross the blood-brain barrier and generally acts peripherally. |
Formulation & handling
- Oral small‑molecule API with very low aqueous solubility, often requiring solubilizers or dispersion strategies for liquid and suspension formulations.
- High lipophilicity (LogP ~4.8) supports solid oral dosage forms but may limit dissolution rate, making particle size control and wetting agents relevant.
- Chemically stable diphenylmethane derivative in solid state; handling is straightforward, with no peptide‑ or biologic‑related sensitivity considerations.
Regulatory status
| Lifecycle | The API’s key Canadian patent expired in 2014, and its U.S. patents lapsed in 2017 and 2022, indicating that exclusivity has ended in both markets. With products already established in the US and Canada, the API is in a mature, post‑patent stage of its lifecycle. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Loperamide is supplied by several originator entities within the same corporate group, with a broad secondary market of repackagers and distributors that indicates mature, widespread availability. Branded products are present in the US and Canada, alongside numerous generic-labeled offerings. Key patents have already expired in both the US and Canada, supporting the long‑established presence of generic competition. |
|---|
Safety
| Toxicity | Oral LD50 is 185 mg/kg in rats. Loperamide overdose can lead to a range of cardiac and non-cardiac effects. Chronic ingestion of doses ranging from 70 mg to 1600 mg daily - which is four to 100 times the recommended dose - resulted in life-threatening cardiac adverse reactions, including QT/QTc and QRS interval prolongation, Torsades de Pointes, Brugada syndrome and other ventricular arrhythmias, syncope, cardiac arrest, and death. These cases included instances of loperamide misuse and abuse. In case of cardiac effects, it is recommended that loperamide is discontinued and therapies to manage and prevent cardiac arrhythmias are initiated.Cases of loperamide overdose may cause opioid toxic effects including CNS depression (e.g. altered mental status, stupor, coordination disorders, somnolence, miosis, muscular hypertonia, respiratory depression), hypotension, urinary retention, and paralytic ileus.Naloxone may reverse the opioid-related toxicity, including CNS and respiratory depression, and hypotension, associated with loperamide overdosage. |
|---|
High Level Warnings:
- High acute toxicity in animal models (oral LD50 ~185 mg/kg in rats) and potential for severe CNS and respiratory depression at supratherapeutic exposure levels
- Chronic high‑dose exposure is associated with serious cardiotoxicity, including QT/QTc and QRS prolongation, ventricular arrhythmias, and cardiac arrest
- Opioid‑like toxicodynamics may lead to CNS depression, hypotension, urinary retention, and paralytic ileus under overdose or misuse conditions
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.
Loperamide is a type of Antidiarrheals
Antidiarrheals are a category of pharmaceutical active pharmaceutical ingredients (APIs) that are commonly used to treat diarrhea. Diarrhea is a common gastrointestinal disorder characterized by frequent loose or watery stools. It can be caused by various factors, including viral or bacterial infections, food poisoning, medication side effects, or digestive disorders.
Antidiarrheals work by targeting the underlying causes of diarrhea to alleviate symptoms and restore normal bowel function. These APIs can be classified into several subcategories, including opioids, antimotility agents, and adsorbents.
Opioid-based antidiarrheals, such as loperamide, function by slowing down intestinal motility and reducing excessive bowel contractions. By doing so, they help to decrease the frequency and urgency of bowel movements.
Antimotility agents, such as diphenoxylate with atropine, act on the intestinal muscles to inhibit peristalsis, the wave-like movements that propel stool through the intestines. This helps to slow down the passage of stools and allows for more efficient absorption of fluids and electrolytes.
Adsorbent antidiarrheals, like activated charcoal, function by binding to toxins and bacteria in the digestive tract, preventing their absorption and facilitating their elimination from the body.
Overall, antidiarrheals are valuable pharmaceutical APIs that provide relief from diarrhea by addressing its underlying causes. It is important to note that these medications should be used under the guidance of healthcare professionals, as the appropriate choice of antidiarrheal and dosage may vary depending on the specific condition and patient characteristics.
Loperamide API manufacturers & distributors
Compare qualified Loperamide API suppliers worldwide. We currently have 12 companies offering Loperamide API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Aquatic Remedies Pvt Ltd | Producer | India | India | CoA | 35 products |
| Fleming Labs. | Producer | India | India | CEP, CoA, GMP, WC | 8 products |
| Isochem | Producer | France | France | CoA, USDMF | 12 products |
| Janssen Pharma | Producer | Belgium | Unknown | CEP, CoA, GMP | 63 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Pharm Rx Chemical Corp | Distributor | United States | India | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Vamsi Labs | Producer | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WHO-GMP | 29 products |
| Vasudha Pharma Chem Ltd. | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, MSDS, USDMF, WC | 37 products |
When sending a request, specify which Loperamide 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 Loperamide 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 Loperamide API
Sourcing
What matters most when sourcing GMP-grade Loperamide?
When sourcing GMP‑grade Loperamide, the priority is securing material that meets US and Canadian regulatory requirements, including complete GMP and quality documentation. Given the mature market and multiple suppliers, confirming traceability through the supply chain is important, especially when using secondary repackagers or distributors. Verifying consistency of specifications and audit readiness across suppliers helps ensure reliable, compliant supply.
Which documents are typically required when sourcing Loperamide API?
Request the core API documentation set: CoA (12 companies), GMP (9 companies), USDMF (6 companies), CEP (5 companies), MSDS (5 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Loperamide API?
Known or reported manufacturers for Loperamide: SEDANAH, Pharm Rx Chemical Corp, SETV Global, Apollo Healthcare Resources (Singapore), LGM Pharma, Vamsi Labs. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Loperamide 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 Loperamide manufacturers?
Audit reports may be requested for Loperamide: 2 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Loperamide API on Pharmaoffer?
Reported supplier count for Loperamide: 12 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Loperamide API?
Production countries reported for Loperamide: India (7 producers), Singapore (1 producer), France (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Loperamide usually hold?
Common certifications for Loperamide suppliers: CoA (12 companies), GMP (9 companies), USDMF (6 companies), CEP (5 companies), MSDS (5 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Loperamide (CAS 53179-11-6) used for?
Loperamide is used for the symptomatic control of acute and chronic diarrhea, including Travelers’ Diarrhea. It is also used off‑label to manage chemotherapy‑related diarrhea when non‑pharmacologic measures are inadequate.
Which therapeutic class does Loperamide fall into?
Loperamide belongs to the following therapeutic categories: Agents causing hyperkalemia, Alimentary Tract and Metabolism, Antiarrhythmic agents, Antidiarrheals, Antidiarrheals, Intestinal Antiinflammatory/antiinfective Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Loperamide mainly prescribed for?
The primary indications for Loperamide: Loperamide is indicated for the relief of diarrhea, including Travelers’ Diarrhea, As an off-label use, it is often used to manage chemotherapy-related diarrhea. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Loperamide work?
Enteric neurons synthesize and release endogenous opioid peptides and other neurotransmitters, such as acetylcholine and substance P. Endogenous opioids bind to opioid receptors expressed on these neurons to regulate gastrointestinal signalling, motility, and balance of fluids and electrolytes.
Loperamide acts on the mu-opioid receptor expressed on the circular and longitudinal intestinal muscle.Receptor binding leads to the recruitment of G-protein receptor kinases and the activation of downstream molecular cascades that inhibit enteric nerve activity.By inhibiting the excitability of enteric neurons, Loperamide suppresses neurotransmitter release, pre-synaptic and post-synaptic inhibition of transmission of excitatory and inhibitory motor pathways, and secretomotor pathways.Loperamide inhibits the release of acetylcholine and prostaglandins,thereby reducing propulsive peristalsis and increasing intestinal transit time.Loperamide stimulates the intestinal absorption of water and electrolytes by inhibiting calmodulin.Loperamide can bind to and hyperpolarize submucosal secretomotor neurons, promoting dry, hard stools.
What should someone know about the safety or toxicity profile of Loperamide?
Loperamide has a dose‑dependent safety profile: therapeutic use is primarily limited to peripheral effects, but supratherapeutic exposure can produce severe CNS and respiratory depression. High doses can cause marked cardiotoxicity, including QT/QTc and QRS prolongation, ventricular arrhythmias, and cardiac arrest due to effects on sodium and hERG potassium channels. Opioid‑like toxicodynamics may also lead to hypotension, urinary retention, and paralytic ileus in overdose or misuse scenarios. Animal data indicate high acute toxicity, with an oral LD50 of about 185 mg/kg in rats.
What are important formulation and handling considerations for Loperamide as an API?
Loperamide’s very low aqueous solubility and high lipophilicity make dissolution rate a key limitation, so solid oral products often use particle‑size control and wetting agents, while liquid or suspension forms may require solubilizers or dispersion systems. Its chemical stability as a diphenylmethane derivative supports conventional solid‑state handling without special sensitivity precautions. For manufacturing, maintaining uniform dispersion and preventing aggregation are important due to its low solubility.
Is Loperamide a small molecule?
Loperamide is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Loperamide?
Loperamide is chemically stable in the solid state, so major degradation issues are not typical for oral solid dosage forms. Its very low aqueous solubility can limit dissolution, making particle size control and use of wetting agents or solubilizers important for consistent performance. Liquid and suspension formulations may require dispersion strategies to maintain uniformity.
Regulatory
Where is Loperamide approved or in use globally?
Loperamide is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Loperamide right now?
In the US and Canada, Loperamide is an approved and widely available generic antidiarrheal active ingredient. It is marketed without exclusivity, reflecting its long-established status and the absence of active patent restrictions on its use as an API.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Loperamide procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Loperamide. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Loperamide included in the PRO Data Insights coverage?
PRO Data Insights coverage for Loperamide: 2284 verified transactions across 662 suppliers and 320 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Loperamide?
Market report availability for Loperamide: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
