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Kaolin API Manufacturers & Suppliers
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Distributor
Produced in
Unknown|
Employees: 275+
|
Audit Report:
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GMP
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MSDS|
BSE/TSE|
ISO9001|
CoAAll certificates
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MSDS
BSE/TSE
ISO9001
CoA
Distributor
Produced in
China|
Employees: 50+
|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
MSDSAll certificates
GMP
FDA
CEP
USDMF
MSDS
BSE/TSE
ISO9001
WC
CoA
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Kaolin | CAS No: 1332-58-7 | GMP-certified suppliers
A medication that provides symptomatic relief for noninfectious diarrhea, including AIDS‑related cases, and general gastrointestinal upset across key markets.
Therapeutic categories
Alimentary Tract and MetabolismAluminium CompoundsAluminum SilicatesAntidiarrhealsAntidiarrheals, Intestinal Antiinflammatory/antiinfective AgentsGastrointestinal Agents
Generic name
Kaolin
Molecule type
small molecule
CAS number
1332-58-7
DrugBank ID
DB01575
Approval status
Approved drug
ATC code
A07BC02
Primary indications
- Used for upset stomach and diarrhea, a traditional medicine used in China, South America and Africa
- Kaolin is also used to treat AIDs-related diarrhea
- Kaolin based bandages are also under investigation
Product Snapshot
- Kaolin is supplied as an oral and topical non‑systemic mineral formulation across liquids, suspensions, gels, creams, ointments, pastes, powders, tablets, sprays, and patches
- It is used for symptomatic management of diarrhea and gastrointestinal upset and for topical absorbent applications, with additional investigative use in kaolin-based bandages
- It is approved and marketed in the US and Canada
Clinical Overview
Kaolin (CAS 1332-58-7) is an inorganic layered silicate mineral classified among post‑transition metal silicates. In pharmaceutical applications, it functions as a non‑systemic intestinal adsorbent. Clinically, kaolin has been used for symptomatic management of acute, noninfectious diarrhea and nonspecific gastrointestinal upset. Historical usage spans traditional medicine systems in China, South America, and Africa. Although no longer the active component in modern Kaopectate formulations, kaolin has been incorporated in antidiarrheal products and remains under investigation in topical bandage preparations designed to modulate moisture and adsorb exudates.
Kaolin exhibits pharmacodynamic activity through physical adsorption rather than biochemical interaction. Its layered silicate structure provides a high surface area capable of binding water, microbial byproducts, and other luminal substances. This adsorption reduces free fluid in the intestinal lumen and contributes to firmer stool consistency. The mechanism is purely local, with no receptor‑based or enzymatic effects.
Systemic absorption of intact kaolin is negligible due to its insoluble mineral nature. Consequently, classical ADME parameters such as plasma protein binding, metabolic pathways, and clearance are not applicable. Transit through the gastrointestinal tract is largely unaltered, and elimination occurs via feces. Lack of systemic exposure limits systemic toxicity, although interactions related to adsorption of concomitant oral medications may occur.
Safety considerations include the potential for constipation, reduced absorption of orally administered drugs, and caution in patients requiring precise therapeutic levels of narrow‑index medications. Use in infectious diarrhea should be guided by clinical judgment because kaolin does not address underlying pathogens. Inhalation of fine particulate material should be avoided during manufacturing or compounding due to respiratory irritation risks.
Kaolin’s relevance in pharmaceutical manufacturing requires attention to mineral purity, particle size distribution, and control of trace metal contaminants. Procurement of the API should prioritize suppliers capable of providing consistent mineralogical composition, validated impurity profiles, and documentation supporting compliance with pharmacopeial standards.
Kaolin exhibits pharmacodynamic activity through physical adsorption rather than biochemical interaction. Its layered silicate structure provides a high surface area capable of binding water, microbial byproducts, and other luminal substances. This adsorption reduces free fluid in the intestinal lumen and contributes to firmer stool consistency. The mechanism is purely local, with no receptor‑based or enzymatic effects.
Systemic absorption of intact kaolin is negligible due to its insoluble mineral nature. Consequently, classical ADME parameters such as plasma protein binding, metabolic pathways, and clearance are not applicable. Transit through the gastrointestinal tract is largely unaltered, and elimination occurs via feces. Lack of systemic exposure limits systemic toxicity, although interactions related to adsorption of concomitant oral medications may occur.
Safety considerations include the potential for constipation, reduced absorption of orally administered drugs, and caution in patients requiring precise therapeutic levels of narrow‑index medications. Use in infectious diarrhea should be guided by clinical judgment because kaolin does not address underlying pathogens. Inhalation of fine particulate material should be avoided during manufacturing or compounding due to respiratory irritation risks.
Kaolin’s relevance in pharmaceutical manufacturing requires attention to mineral purity, particle size distribution, and control of trace metal contaminants. Procurement of the API should prioritize suppliers capable of providing consistent mineralogical composition, validated impurity profiles, and documentation supporting compliance with pharmacopeial standards.
Identification & chemistry
| Generic name | Kaolin |
|---|---|
| Molecule type | Small molecule |
| CAS | 1332-58-7 |
| UNII | 24H4NWX5CO |
| DrugBank ID | DB01575 |
Pharmacology
| Summary | Kaolin acts as a non‑systemic adsorptive agent that binds water, microbial toxins, and bacteria within the gastrointestinal tract. This reduces luminal fluid content and contributes to firmer stools in conditions characterized by diarrhea. Its activity is limited to the gut lumen, with no known direct receptor‑mediated effects. |
|---|---|
| Mechanism of action | Kaolin adsorbs water, toxins and bacteria, contributing to firmer stools, reducing fluid loss from diarrhea. |
| Pharmacodynamics | Kaolin is an adsorptive agent. |
Formulation & handling
- Kaolin is an inorganic, water‑insoluble solid typically formulated as oral suspensions or chewable solids, requiring attention to particle-size control and uniform re-dispersion.
- Oral products rely on stable aqueous suspensions with appropriate rheology modifiers to prevent sedimentation and ensure consistent dosing performance.
- Topical forms (creams, pastes, powders) use kaolin as an adsorbent/absorbent excipient, with standard stability considerations for hydrated mineral solids and avoidance of microbial contamination in water-containing systems.
Regulatory status
| Lifecycle | I can draft the summary, but I need the patent‑expiry timing for the API. Please provide the key patent expiry date(s). |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Kaolin is supplied by a small group of established packagers, which function primarily as processors of this mineral-based excipient rather than as originator innovators. Branded and finished‑product uses appear in the US and Canada, with additional product presence in other regions through cosmetic and OTC formulations. As a non‑patented, widely used excipient, kaolin faces no patent barriers, and broad generic and multi‑source availability is already established. |
|---|
Kaolin 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.
Kaolin API manufacturers & distributors
Compare qualified Kaolin API suppliers worldwide. We currently have 2 companies offering Kaolin 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.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
When sending a request, specify which Kaolin 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 Kaolin 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 Kaolin API
Sourcing
What matters most when sourcing GMP-grade Kaolin?
Key considerations include verifying compliance with US and Canadian regulatory expectations for excipient GMP and confirming that the processor has appropriate controls for mineral sourcing and handling. Consistency of physical and chemical quality is important because Kaolin is supplied by processors rather than originator manufacturers. It is also essential to ensure reliable multi‑source supply and documented quality systems suited to pharmaceutical use.
Which documents are typically required when sourcing Kaolin API?
Request the core API documentation set: GMP (2 companies), CoA (2 companies), ISO9001 (2 companies), MSDS (2 companies), BSE/TSE (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Kaolin API?
Known or reported manufacturers for Kaolin: Caesar & Loretz GmbH (CAELO), Aurora Industry Co., Ltd. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Kaolin 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 Kaolin manufacturers?
Audit reports may be requested for Kaolin: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Kaolin API on Pharmaoffer?
Reported supplier count for Kaolin: 2 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Kaolin API?
Production countries reported for Kaolin: China (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Kaolin usually hold?
Common certifications for Kaolin suppliers: GMP (2 companies), CoA (2 companies), ISO9001 (2 companies), MSDS (2 companies), BSE/TSE (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Kaolin (CAS 1332-58-7) used for?
Kaolin is used as a non‑systemic intestinal adsorbent for symptomatic management of acute, noninfectious diarrhea and nonspecific gastrointestinal upset. It works by physically binding water and luminal substances to reduce stool fluidity. It is also investigated in topical bandage preparations where moisture and exudate adsorption are needed.
Which therapeutic class does Kaolin fall into?
Kaolin belongs to the following therapeutic categories: Alimentary Tract and Metabolism, Aluminium Compounds, Aluminum Silicates, Antidiarrheals, Antidiarrheals, Intestinal Antiinflammatory/antiinfective Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Kaolin mainly prescribed for?
The primary indications for Kaolin: Used for upset stomach and diarrhea, a traditional medicine used in China, South America and Africa, Kaolin is also used to treat AIDs-related diarrhea, Kaolin based bandages are also under investigation. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Kaolin work?
Kaolin adsorbs water, toxins and bacteria, contributing to firmer stools, reducing fluid loss from diarrhea.
What should someone know about the safety or toxicity profile of Kaolin?
Kaolin is an insoluble mineral that acts locally in the gastrointestinal tract, with negligible systemic absorption and a low risk of systemic toxicity. Expected effects include constipation and reduced absorption of co‑administered oral drugs, which is important for therapies requiring precise dosing. It should not be inhaled as fine particulate matter due to the risk of respiratory irritation. Use in diarrhea should be guided by clinical judgment, as it does not address infectious causes.
What are important formulation and handling considerations for Kaolin as an API?
Kaolin requires controlled particle size and uniform dispersion to prepare consistent oral suspensions or chewable solids. Aqueous suspensions need suitable rheology modifiers to limit sedimentation and maintain dose uniformity. Topical forms use Kaolin as an adsorbent or absorbent and should follow standard stability practices for hydrated mineral solids, including measures to prevent microbial contamination in water‑containing systems.
Is Kaolin a small molecule?
Kaolin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Kaolin?
Oral Kaolin products require control of particle size and formulation rheology to limit sedimentation and allow uniform re‑dispersion during storage. Aqueous suspensions should maintain consistent viscosity to ensure accurate dosing throughout shelf life. Standard precautions to prevent microbial contamination apply to water‑containing formulations.
Regulatory
Where is Kaolin approved or in use globally?
Kaolin 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.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Kaolin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Kaolin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Kaolin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Kaolin: 199 verified transactions across 29 suppliers and 36 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Kaolin?
Market report availability for Kaolin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
