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Cholestyramine | CAS No: 11041-12-6 | GMP-certified suppliers
A medication that supports reducing elevated LDL levels in primary hypercholesterolemia and helps relieve pruritus associated with partial biliary obstruction for clinical use.
Therapeutic categories
Primary indications
- Indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet
- Also for the relief of pruritus associated with partial biliary obstruction
Product Snapshot
- Cholestyramine is supplied mainly as an oral, non‑absorbed resin in powder, granule, and tablet formulations for suspension or solution
- It is used for LDL‑cholesterol reduction in primary hypercholesterolemia and for pruritus associated with partial biliary obstruction
- It is approved in the US and Canada, with additional investigational listings in some markets
Clinical Overview
The pharmacologic effect is based on interrupting the enterohepatic circulation of bile acids. During normal digestion, bile acids are secreted into the intestine and largely reabsorbed for return to the liver. Cholestyramine binds intestinal bile acids to form insoluble complexes that are excreted in feces. This removal of bile acids prompts increased hepatic conversion of cholesterol to bile acids, reducing circulating LDL levels.
The mechanism of action reflects the resin’s structure as a strong anion exchanger. Its quaternary ammonium functional groups, attached to a styrene–divinylbenzene copolymer matrix, exchange chloride ions for negatively charged bile acids present in the intestinal lumen. The resulting resin–bile acid complex is not systemically absorbed.
Because cholestyramine is not absorbed, systemic pharmacokinetic parameters such as distribution, metabolism, and elimination are not applicable. Its clinical activity depends on gastrointestinal residence time and binding capacity rather than systemic exposure.
Safety considerations include gastrointestinal effects such as constipation, bloating, and nausea. Long‑term use may reduce absorption of fat‑soluble vitamins or other drugs due to nonspecific binding, requiring attention to dosing intervals and nutritional monitoring. It is not associated with systemic toxicity due to its lack of absorption, but excessive dosage may compound gastrointestinal obstruction risk.
Cholestyramine is widely marketed in powder formulations under various regional brand names. For API procurement, suppliers should provide evidence of polymer consistency, particle size control, and binding capacity, along with full compliance to relevant monographs and impurity specifications to ensure reproducible performance in finished dosage forms.
Identification & chemistry
| Generic name | Cholestyramine |
|---|---|
| Molecule type | Small molecule |
| CAS | 11041-12-6 |
| UNII | 4B33BGI082 |
| DrugBank ID | DB01432 |
Pharmacology
| Summary | Cholestyramine is an anion‑exchange resin that binds bile acids in the intestinal lumen, forming insoluble complexes that are excreted in the feces. By interrupting enterohepatic recirculation of bile acids, it increases hepatic demand for bile acid synthesis from cholesterol, contributing to reduced circulating LDL levels. Its pharmacologic action also decreases bile acid accumulation in partial biliary obstruction, supporting symptomatic relief of pruritus. |
|---|---|
| Mechanism of action | Cholestyramine forms a resin that acts as a bile acid sequestrant to limit the reabsorption of bile acids in the gastrointestinal tract. Cholestyramine resin is a strong anion exchange resin, allowing it to exchange its chloride anions with anionic bile acids present in the gastrointestinal tract and form a strong resin matrix. Cholestyramine consists of a functional group, which is a quaternary ammonium group attached to an inert styrene-divinylbenzene copolymer, in the anion exchange resin. |
| Pharmacodynamics | Cholesterol is probably the sole precursor of bile acids. During normal digestion, bile acids are secreted into the intestines. A major portion of the bile acids is absorbed from the intestinal tract and returned to the liver via the enterohepatic circulation. Only very small amounts of bile acids are found in normal serum. Cholestyramine resin adsorbs and combines with the bile acids in the intestine to form an insoluble complex which is excreted in the feces. This results in a partial removal of bile acids from the enterohepatic circulation by preventing their absorption. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Bile acids | Humans | binder |
ADME / PK
| Absorption | Not absorbed from the gastrointestinal tract following oral administration. |
|---|---|
| Half-life | 6 minutes |
| Metabolism | Bile acids |
| Route of elimination | Cholestyramine resin adsorbs and combines with the bile acids in the intestine to form an insoluble complex which is excreted in the feces. |
Formulation & handling
- Cholestyramine is a non‑absorbed anion‑exchange resin formulated as oral powders or granules that require dispersion in adequate fluids to form a drinkable suspension.
- Its insoluble polymeric nature necessitates attention to uniform wetting and agitation to minimize grittiness and ensure consistent dispersion performance.
- Co‑administration with meals or fluids is recommended, and formulations should account for its potential to bind concomitant oral medications.
Regulatory status
| Lifecycle | Patent‑expiry timing was not provided, so a specific lifecycle determination cannot be made. In general, for products marketed in Canada and the US, lifecycle maturity depends on whether core patents or exclusivities have expired or are nearing expiry, which typically signals transition toward a more competitive, post‑exclusivity market phase. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Cholestyramine is an established bile acid sequestrant with no single dominant originator, and production is supported by multiple manufacturers and repackagers that supply finished formulations and bulk material. The product is marketed primarily in the US and Canada under several branded and unbranded presentations, reflecting mature global availability. Patent expiry occurred long ago, and the ingredient is fully open to generic competition, which is evident from the broad base of suppliers. |
|---|
Safety
| Toxicity | Overdose may result in blockage of intestine or stomach. |
|---|
- Excess quantities can precipitate gastrointestinal obstruction
- Handle and meter bulk material to prevent accidental over‑administration in formulated products
- Monitor for high-viscosity agglomeration during processing, as physical properties may contribute to luminal blockage if concentration limits are exceeded
Cholestyramine is a type of Bile acid sequestrants
Bile acid sequestrants belong to the pharmaceutical API subcategory of cholesterol-lowering agents. These agents are primarily used in the management of hypercholesterolemia and related cardiovascular conditions. Bile acid sequestrants function by binding to bile acids in the gastrointestinal tract, forming a complex that prevents their reabsorption. This mechanism promotes the excretion of bile acids in the feces and subsequently increases the hepatic conversion of cholesterol to bile acids, leading to a reduction in circulating cholesterol levels.
Bile acid sequestrants are commonly prescribed as adjunct therapy to statins or as an alternative for individuals who cannot tolerate statin therapy. They are typically administered orally in the form of powders, tablets, or granules, and they are not absorbed into the bloodstream. This characteristic makes them relatively safe, with a low risk of systemic side effects.
The main bile acid sequestrants used in clinical practice include cholestyramine, colesevelam, and colestipol. These agents have demonstrated efficacy in reducing low-density lipoprotein cholesterol (LDL-C) levels and improving lipid profiles. Additionally, they may have secondary benefits, such as improving glycemic control in patients with type 2 diabetes and reducing the risk of cardiovascular events.
Overall, bile acid sequestrants play a vital role in managing hypercholesterolemia and are an important component of cardiovascular disease management. With their cholesterol-lowering properties and favorable safety profile, they offer an effective therapeutic option for patients seeking to improve their lipid profiles and reduce their risk of cardiovascular complications.
Cholestyramine (Bile acid sequestrants), 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.
Cholestyramine API manufacturers & distributors
Compare qualified Cholestyramine API suppliers worldwide. We currently have 4 companies offering Cholestyramine 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 |
|---|---|---|---|---|---|
| Dow France | Producer | France | France | CEP, CoA, GMP | 1 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Phaex Polymers | Producer | India | India | CoA, WC | 2 products |
| Purolite | Producer | United Kingdom | Unknown | CoA, JDMF, USDMF | 2 products |
When sending a request, specify which Cholestyramine 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 Cholestyramine 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 Cholestyramine API
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Technical
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Regulatory
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