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Clidinium API Manufacturers & Suppliers

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Commercial-scale Suppliers

Distributor
Produced in  World
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Employees: +250

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CoA

All certificates

GMP
CoA
Producer
Produced in  India
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: USDMF
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CoA

All certificates

USDMF
CoA
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Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
WHO-GMP
|
CoA

All certificates

GMP
WHO-GMP
CoA
Not active
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Clidinium | CAS No: 7020-55-5 | GMP-certified suppliers

A medication that provides symptomatic relief for peptic ulcer disease and gastrointestinal spasms associated with irritable bowel syndrome, diverticulitis, and colicky abdominal pain.

Therapeutic categories

Acids, CarbocyclicAgents producing tachycardiaAlimentary Tract and MetabolismAnticholinergic AgentsAutonomic AgentsBenzilates
Generic name
Clidinium
Molecule type
small molecule
CAS number
7020-55-5
DrugBank ID
DB00771
Approval status
Approved drug
ATC code
A03CA02

Primary indications

  • For the treatment of peptic ulcer disease and also to help relieve abdominal or stomach spasms or cramps due to colicky abdominal pain, diverticulitis, and irritable bowel syndrome
  • In combination with chlordiazepoxide, clidinium is indicated to control emotional and somatic factors in gastrointestinal disorders, and is used as adjunctive therapy in the treatment of peptic ulcer, irritable bowel syndrome and acute enterocolitis

Product Snapshot

  • Clidinium is available as oral tablets and capsules, including sugar-coated and gelatin-coated formulations
  • It is primarily indicated for use in gastrointestinal disorders such as peptic ulcer disease, abdominal spasms, irritable bowel syndrome, and acute enterocolitis
  • Clidinium is approved for use in key regulatory markets including the United States and Canada

Clinical Overview

Clidinium is a synthetic anticholinergic agent primarily indicated for the treatment of peptic ulcer disease and the symptomatic relief of gastrointestinal spasms and cramps associated with colicky abdominal pain, diverticulitis, and irritable bowel syndrome. It is also employed in combination with chlordiazepoxide to address emotional and somatic factors in gastrointestinal disorders, serving as adjunctive therapy in acute enterocolitis and other functional gastrointestinal conditions.

Pharmacologically, clidinium exerts its effects by inhibiting the muscarinic actions of acetylcholine at postganglionic parasympathetic neuroeffector sites. The principal mechanism of action involves antagonism of M1 muscarinic receptors, resulting in a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract. This action reduces smooth muscle contraction and gastric secretions, thereby alleviating symptoms associated with hypermotility and excessive acid production.

In terms of absorption, distribution, metabolism, and excretion (ADME), detailed human pharmacokinetic data on clidinium are limited in the public domain. As an anticholinergic compound, it is expected to exhibit typical characteristics including partial absorption via the gastrointestinal tract, with hepatic metabolism followed by renal elimination of metabolites. The drug’s effects are generally observed following oral administration.

Safety considerations for clidinium include its anticholinergic side effect profile, which may manifest as dry mouth, blurred vision, urinary retention, constipation, and tachycardia. Caution is advised when administering to populations susceptible to these effects, such as the elderly or patients with glaucoma, obstructive uropathy, or cardiovascular conditions. Monitoring for central nervous system depression is warranted when used in combination with CNS depressants like chlordiazepoxide.

Clidinium is classified within the diphenylmethane chemical family and categorized pharmacologically as a muscarinic antagonist and parasympatholytic agent. It is marketed under various formulations globally, often in combination products targeting gastrointestinal disorders.

When sourcing clidinium API, quality considerations should include verification of chemical purity, absence of residual solvents, and compliance with pharmacopeial standards. Stability under typical storage conditions and batch-to-batch consistency are critical to ensure therapeutic efficacy and safety in finished pharmaceutical products. Robust supplier qualification and audit processes are recommended to maintain supply chain integrity.

Identification & chemistry

Generic name Clidinium
Molecule type Small molecule
CAS 7020-55-5
UNII BO76JF850N
DrugBank ID DB00771

Pharmacology

SummaryClidinium is a synthetic anticholinergic agent that inhibits muscarinic acetylcholine M1 receptors at postganglionic parasympathetic sites. Its pharmacodynamic effects include antispasmodic and antisecretory actions on the gastrointestinal tract. This mechanism contributes to its therapeutic role in managing gastrointestinal disorders characterized by spasms and secretory disturbances.
Mechanism of actionInhibits muscarinic actions of acetylcholine at postganglionic parasympathetic neuroeffector sites primarily by inhibiting the M1 muscarinic receptors.
PharmacodynamicsClidinium is a synthetic anticholinergic agent which has been shown in experimental and clinical studies to have a pronounced antispasmodic and antisecretory effect on the gastrointestinal tract.
Targets
TargetOrganismActions
Muscarinic acetylcholine receptor M1Humansantagonist

Formulation & handling

  • Clidinium is a small molecule API formulated primarily for oral administration in various coated tablet and capsule forms. It exhibits low water solubility (3.77e-04 g/L) and a LogP of -1.1, indicating limited lipophilicity and potential challenges in bioavailability. Handling instructions include advising administration before meals and avoiding concomitant alcohol consumption due to enhanced CNS depressant effects.

Regulatory status

LifecycleThe active pharmaceutical ingredient's primary patents have expired in both Canada and the US, supporting the availability of generic formulations and indicating a mature market with established competition.
MarketsCanada, US
Supply Chain
Supply chain summaryClidinium is originally manufactured by Hoffmann-La Roche Inc., with branded products marketed primarily in the US and Canada. Multiple packaging and generic companies are involved in distribution, indicating a well-established generic supply landscape. The presence of numerous generic packagers suggests that patent protections have expired or are nearing expiry, allowing generic competition in these markets.

Safety

ToxicitySigns of toxicity include confusion, paralytic ileus, urinary hesitancy/retention, and blurred vision.
High Level Warnings:
  • Exposure may cause central nervous system effects such as confusion
  • Potential anticholinergic adverse effects include paralytic ileus, urinary retention, and blurred vision
  • Handle with appropriate protective equipment to minimize inhalation and dermal contact

Clidinium is a type of Anticholinergics/Parasympathemimetics


Anticholinergics/Parasympathomimetics are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the medical field. These compounds exhibit specific pharmacological actions by targeting the cholinergic system in the body.

Anticholinergics are drugs that block the action of acetylcholine, a neurotransmitter that regulates various bodily functions. By inhibiting the activity of acetylcholine, anticholinergics can have diverse therapeutic effects, including reducing muscle spasms, decreasing gastrointestinal motility, and alleviating symptoms associated with certain respiratory conditions.

On the other hand, parasympathomimetics, also known as cholinomimetics, mimic the action of acetylcholine by stimulating cholinergic receptors. These compounds enhance the parasympathetic nervous system, which is responsible for the "rest and digest" functions of the body. Parasympathomimetics are commonly used to treat conditions such as glaucoma, urinary retention, and Alzheimer's disease.

The use of anticholinergics/parasympathomimetics requires careful consideration and medical supervision due to their potential side effects, which can include dry mouth, blurred vision, urinary retention, constipation, and cognitive impairment. These medications are available in various forms, including tablets, capsules, patches, and inhalers, and their dosage is determined by the specific medical condition being treated.

Overall, anticholinergics/parasympathomimetics play a vital role in modern medicine, providing targeted therapeutic effects by modulating the cholinergic system. Their usage has significantly improved patient outcomes in various medical conditions and continues to be an important category of pharmaceutical APIs.


Clidinium (Anticholinergics/Parasympathemimetics), classified under Autonomic Nervous System Agents


Autonomic Nervous System Agents are a crucial category of pharmaceutical active ingredients (APIs) that target the autonomic nervous system (ANS). The ANS plays a vital role in regulating essential bodily functions such as heart rate, blood pressure, digestion, and respiratory rate. This category of pharmaceutical APIs encompasses a wide range of drugs designed to modulate the activity of the ANS.

One subcategory within Autonomic Nervous System Agents is the Sympathomimetic agents, which mimic the effects of the sympathetic nervous system. These drugs are often used to treat conditions such as asthma, nasal congestion, and hypotension by stimulating specific adrenergic receptors.

Conversely, Sympatholytic agents act to inhibit or block the sympathetic nervous system. They are employed to treat hypertension, anxiety, and certain cardiac conditions by reducing sympathetic activity.

Another subcategory is Parasympathomimetic agents, which mimic the effects of the parasympathetic nervous system. These drugs are commonly used to treat glaucoma, urinary retention, and certain gastrointestinal disorders by stimulating cholinergic receptors.

Parasympatholytic agents, on the other hand, act to block the parasympathetic nervous system. They find applications in the treatment of conditions such as overactive bladder and irritable bowel syndrome by inhibiting cholinergic receptors.

The Autonomic Nervous System Agents API category includes various drugs with distinct mechanisms of action that enable healthcare professionals to fine-tune the balance of the autonomic nervous system. By targeting specific receptors and pathways, these pharmaceutical APIs provide valuable therapeutic options for managing a wide range of medical conditions related to autonomic dysfunction.



Clidinium API manufacturers & distributors

Compare qualified Clidinium API suppliers worldwide. We currently have 3 companies offering Clidinium API, with manufacturing taking place in 2 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
India India CoA, USDMF119 products
Producer
India India CoA, GMP, WHO-GMP34 products
Distributor
Jordan World CoA, GMP70 products

When sending a request, specify which Clidinium 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 Clidinium 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.