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Orlipastatum (Orlistat) API Manufacturers & Suppliers
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Distributor
Produced in
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Employees: 200+
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GMP
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USDMF|
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CoAAll certificates
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MSDS
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China|
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Singapore|
Employees: 50+
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China|
Employees: 50+
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Audit Report:
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CoA
Producer
Produced in
India|
Employees: 10000
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Audit Report:
Certifications:
GMP
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USDMF|
WC|
CoAAll certificates
GMP
USDMF
WC
CoA
Producer
Produced in
China|
Audit Report:
Certifications:
WC
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CoAAll certificates
WC
CoA
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India|
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Slovenia|
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GMP
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CoAAll certificates
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Producer
Produced in
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Certifications:
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WC|
CoAAll certificates
USDMF
WC
CoA
Producer
Produced in
Taiwan|
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USDMF
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CoAAll certificates
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CoA
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Distributor
Produced in
China|
Audit Report:
Certifications:
coa
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coa
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
USDMF|
WC|
CoAAll certificates
GMP
USDMF
WC
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
USDMF
|
CoAAll certificates
USDMF
CoA
Producer
Produced in
India|
Audit Report:
Certifications:
GMP
|
FDA|
ISO|
ISO 9001|
coaAll certificates
GMP
FDA
ISO
ISO 9001
coa
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Orlistat | CAS No: 96829-58-2 | GMP-certified suppliers
A medication that supports obesity management in overweight and obese adults by aiding weight loss and maintenance when combined with appropriate dietary measures across major markets.
Therapeutic categories
Alimentary Tract and MetabolismAnti-Obesity AgentsAntiobesity Preparations, Excl. Diet ProductsCytochrome P-450 CYP3A InducersCytochrome P-450 CYP3A4 InducersCytochrome P-450 CYP3A4 Inducers (strength unknown)
Generic name
Orlistat
Molecule type
small molecule
CAS number
96829-58-2
DrugBank ID
DB01083
Approval status
Approved drug, Investigational drug
ATC code
A08AB01
Primary indications
- Orlistat is indicated for obesity management including weight loss and weight maintenance when used in combination with calorie reduction in overweight and obese adults
- This indication applies to both the prescription formulation of 120 mgand the over-the-counter formulation of 60 mg
- Orlistat in the 120 mg prescription formulation is also indicated to reduce the risk of weight regain following weight loss
Product Snapshot
- Orlistat is an oral small‑molecule lipase inhibitor supplied mainly as capsules and tablets in various coated and liquid‑filled formats
- It is used for obesity management, including weight loss, weight maintenance, and mitigation of weight regain
- It is approved in the US, EU, and Canada, with some investigational status in additional markets
Clinical Overview
Orlistat (CAS 96829-58-2) is a gastrointestinal lipase inhibitor indicated for the management of obesity in adults. It is used to support weight reduction and maintenance when combined with a calorie‑restricted diet. The 120 mg prescription formulation is additionally indicated to reduce the risk of weight regain following prior weight loss, while the 60 mg formulation is available for nonprescription use in some regions.
Clinically, orlistat is used in overweight and obese adults where lifestyle modification alone has been insufficient. Its therapeutic effect is localized to the gastrointestinal tract and does not depend on systemic pharmacological activity.
Orlistat exerts its action through potent, selective inhibition of gastric and pancreatic lipases. The molecule forms a covalent bond with serine residues in the catalytic sites of these enzymes, blocking triglyceride hydrolysis. As a result, a proportion of dietary fat is excreted unchanged, reducing absorption of fatty acids and monoacylglycerols. This peripheral mechanism distinguishes orlistat from centrally acting anti‑obesity agents.
Systemic exposure to orlistat is minimal due to negligible absorption, and pharmacodynamic effects are confined to the intestinal lumen. Because circulating concentrations are typically low or undetectable, classical pharmacokinetic parameters such as distribution and metabolism are limited in clinical relevance. Unabsorbed drug is predominantly eliminated in feces.
Safety considerations include gastrointestinal effects such as steatorrhea, oily spotting, and increased stool frequency, which reflect unabsorbed dietary fat. These events are dose dependent and frequently attenuate with continued treatment or dietary modification. Rare cases of severe liver injury and kidney injury related to oxalate nephropathy have been reported. Interference with absorption of fat‑soluble vitamins may occur, and supplementation is often recommended.
Orlistat has been marketed globally under prescription and over‑the‑counter brands. For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemistry, impurity profiles, and particle properties, alongside full regulatory documentation to support formulation and registration activities.
Clinically, orlistat is used in overweight and obese adults where lifestyle modification alone has been insufficient. Its therapeutic effect is localized to the gastrointestinal tract and does not depend on systemic pharmacological activity.
Orlistat exerts its action through potent, selective inhibition of gastric and pancreatic lipases. The molecule forms a covalent bond with serine residues in the catalytic sites of these enzymes, blocking triglyceride hydrolysis. As a result, a proportion of dietary fat is excreted unchanged, reducing absorption of fatty acids and monoacylglycerols. This peripheral mechanism distinguishes orlistat from centrally acting anti‑obesity agents.
Systemic exposure to orlistat is minimal due to negligible absorption, and pharmacodynamic effects are confined to the intestinal lumen. Because circulating concentrations are typically low or undetectable, classical pharmacokinetic parameters such as distribution and metabolism are limited in clinical relevance. Unabsorbed drug is predominantly eliminated in feces.
Safety considerations include gastrointestinal effects such as steatorrhea, oily spotting, and increased stool frequency, which reflect unabsorbed dietary fat. These events are dose dependent and frequently attenuate with continued treatment or dietary modification. Rare cases of severe liver injury and kidney injury related to oxalate nephropathy have been reported. Interference with absorption of fat‑soluble vitamins may occur, and supplementation is often recommended.
Orlistat has been marketed globally under prescription and over‑the‑counter brands. For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemistry, impurity profiles, and particle properties, alongside full regulatory documentation to support formulation and registration activities.
Identification & chemistry
| Generic name | Orlistat |
|---|---|
| Molecule type | Small molecule |
| CAS | 96829-58-2 |
| UNII | 95M8R751W8 |
| DrugBank ID | DB01083 |
Pharmacology
| Summary | Orlistat is a gastrointestinal lipase inhibitor that blocks gastric and pancreatic lipases through covalent binding to active-site serine residues. This inhibition reduces the hydrolysis and absorption of dietary triglycerides, lowering uptake of fatty acids and monoglycerides. Its pharmacologic effect supports weight reduction and weight maintenance by limiting systemic exposure to dietary fats. |
|---|---|
| Mechanism of action | Orlistat is a potent and selective inhibitor of various lipase enzymes responsible for the metabolism of fat. It acts in the gastrointestinal (GI) tract via covalent binding to the serine residues located on the active site of both gastric and pancreatic lipase. When orlistat is taken with food containing fat, it partially inhibits the hydrolysis of triglycerides. This decreases absorption of monoaclglycerides and free fatty acids, contributing to weight maintenance and weight loss. |
| Pharmacodynamics | Orlistat helps with weight reduction and maintenance by inhibiting the absorption of dietary fats via the inhibition of lipase enzymes. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Pancreatic triacylglycerol lipase | Humans | inhibitor |
| Gastric triacylglycerol lipase | Humans | inhibitor |
| Fatty acid synthase | Humans | inhibitor |
ADME / PK
| Absorption | The systemic absorption and exposure of orlistat is low, however, systemic absorption of the drug is not required for orlistat activity.After an oral dose with 360 mg of radiolabeled orlistat, plasma radioactivity achieved a peak at about 8 hours. Plasma concentrations of unchanged parent drug were close to the lower end of detection limits (<5 ng/mL). In plasma samples of patients taking orlistat, the detection of unchanged drug was sporadic and very low concentrations were detected (<10 ng/mL or 0.02 μM) with no evidence suggesting drug accumulation. |
|---|---|
| Half-life | The half-life of orlistat of the small amount of absorbed orlistat ranges between 1-2 hours. |
| Protein binding | Orlistat is >99% bound to plasma proteins (mainly lipoproteins and albumin). |
| Metabolism | Orlistat is hydrolyzed in the intestinal wall.In a radiolabeled orlistat mass balance study in obese patients, two metabolites were identified. The first metabolite, M1, was the hydrolyzed β-lactone ring product of orlistat. The second metabolite, M3, was produced from M1’s cleavage of the N-formyl leucine side-chain. Both metabolites accounted for about 42% of total plasma radioactivity. Both M1 and M3 are considered pharmacologically inactive. |
| Route of elimination | After single oral dose of radiolabled orlistat in both normal weight and obese volunteers fecal excretion of the unabsorbed drug was found to be the major route of elimination with <2% urinary excretion.Fecal elimination of orlistat is estimated between 95-97%.Complete excretion by both routes occurs within in 3 to 5 days. |
| Volume of distribution | Volume of distribution cannot be obtained because the absorption of orlistat is minimal. Orlistat is minimally distributed to erythrocytes and is primarily bound to proteins. |
Formulation & handling
- Oral small‑molecule API with extremely low aqueous solubility and high lipophilicity, favoring lipid‑based or dispersion systems for adequate dissolution.
- Solid‑state stability is generally good, but handling should minimize moisture and ensure uniform dispersion due to waxy, hydrophobic character.
- Formulation and administration are food‑dependent, as fat co‑ingestion enhances luminal dispersion and therapeutic activity.
Regulatory status
| Lifecycle | The active ingredient appears to be in a mature stage of its lifecycle, with key US patents expired by 2018–2009 and Canadian protections ending by 2020. With marketing already established in the US, EU, and Canada, the product is likely operating in markets with full generic competition or nearing complete genericization. |
|---|
| Markets | US, EU, Canada |
|---|
Supply Chain
| Supply chain summary | Orlistat’s supply landscape includes established originator manufacturers associated with both prescription and OTC branded products, supported by numerous secondary packagers that handle distribution across the US, EU, and Canada. Branded presence is global, with both prescription and non‑prescription formulations available in major markets. Key US and Canadian patents have expired, indicating that generic competition is already established or fully enabled. |
|---|
Safety
| Toxicity | The oral LD50 of orlistat is >5000 mg/kg in rats.Single orlistat doses of 800 mg and multiple doses of up to 400 mg three times a day for 15 days have been administered to healthy weight and obese subjects without clinically significant adverse findings. In addition, doses of 240 mg three times a day have been given to obese patients for 6 months without a significant adverse effects. Post-marketing reports of overdoses cases indicate no adverse events or adverse events that are similar to those reported with the recommended dose. If a significant overdose with orlistat occurs, the patient should be observed for at least 24 hours. Based on the results of clinical studies, systemic effects caused by orlistat are likely to be rapidly reversible. |
|---|
High Level Warnings:
- Oral LD50 in rats exceeds 5000 mg/kg, indicating low acute systemic toxicity under standard laboratory conditions
- Clinical and post‑marketing data show minimal systemic adverse effects even at supratherapeutic exposures, consistent with the compound’s limited absorption and rapidly reversible systemic profile
- Handling considerations focus on avoiding unnecessary exposure to high dust levels
Orlistat is a type of Lipid-lowering agents
Lipid-lowering agents are a category of pharmaceutical active ingredients (APIs) that are widely used in the treatment of hyperlipidemia, a condition characterized by elevated levels of lipids (such as cholesterol and triglycerides) in the blood. These agents play a crucial role in managing lipid abnormalities and reducing the risk of cardiovascular diseases.
One of the most commonly prescribed lipid-lowering agents is statins. Statins work by inhibiting an enzyme called HMG-CoA reductase, which is responsible for the production of cholesterol in the liver. By blocking this enzyme, statins effectively lower cholesterol levels in the bloodstream.
Another class of lipid-lowering agents is fibric acid derivatives, which primarily target triglyceride levels. These agents activate a nuclear receptor known as PPAR-alpha, which regulates lipid metabolism. By activating PPAR-alpha, fibric acid derivatives enhance the breakdown of triglycerides and increase the elimination of fatty acids from the bloodstream.
Additionally, bile acid sequestrants are often used as lipid-lowering agents. These agents bind to bile acids in the intestine, preventing their reabsorption. As a result, the liver utilizes more cholesterol to produce new bile acids, leading to a decrease in circulating cholesterol levels.
Lipid-lowering agents are available in various formulations, including tablets, capsules, and suspensions, allowing for convenient administration. They are usually prescribed alongside lifestyle modifications, such as dietary changes and regular exercise, to optimize the management of hyperlipidemia.
It is important to note that the use of lipid-lowering agents should be under the supervision of a healthcare professional, as they may have potential side effects and interactions with other medications. Proper monitoring of lipid levels and regular follow-up visits are essential for ensuring the effectiveness and safety of these pharmaceutical agents.
Orlistat API manufacturers & distributors
Compare qualified Orlistat API suppliers worldwide. We currently have 16 companies offering Orlistat 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 |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 176 products |
| Biocon | Producer | India | India | CoA, GMP, USDMF, WC | 36 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 235 products |
| Chongqing Zein | Producer | China | China | CoA, WC | 2 products |
| Divis Labs. | Producer | India | India | CoA, FDA, GMP, ISO9001, Other | 47 products |
| Formosa Labs | Producer | Taiwan | Taiwan | CoA, USDMF | 36 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| Murli Krishna Pharma Pvt.... | Producer | India | India | CoA, USDMF | 7 products |
| Patco Exports | Distributor | India | India | CoA | 1 products |
| Shandong N.T. Pharma | Producer | China | China | CoA, USDMF, WC | 12 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Sun Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 219 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, WC | 69 products |
When sending a request, specify which Orlistat 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 Orlistat 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 Orlistat API
Sourcing
What matters most when sourcing GMP-grade Orlistat?
The most important factors are compliance with US, EU, and Canadian GMP and the supplier’s ability to document this with current regulatory filings and audits. Source from manufacturers with established production histories for Orlistat and clear control over any secondary packaging steps. Since key patents have expired and generic competition is enabled, verify that the supplier’s regulatory status aligns with the intended prescription or OTC use in each market.
Which documents are typically required when sourcing Orlistat API?
Request the core API documentation set: CoA (17 companies), USDMF (9 companies), GMP (8 companies), WC (7 companies), ISO9001 (5 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Orlistat API?
Known or reported manufacturers for Orlistat: Xi'an Tian Guangyuan Biotech Co.,Ltd, Changzhou Comwin Fine Chemicals Co., Ltd, Sinoway industrial Co.,Ltd, Apollo Healthcare Resources (Singapore), Arshine Pharmaceutical Co., Limited. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Orlistat 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 Orlistat manufacturers?
Audit reports may be requested for Orlistat: 3 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Orlistat API on Pharmaoffer?
Reported supplier count for Orlistat: 17 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Orlistat API?
Production countries reported for Orlistat: China (8 producers), India (6 producers), Singapore (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Orlistat usually hold?
Common certifications for Orlistat suppliers: CoA (17 companies), USDMF (9 companies), GMP (8 companies), WC (7 companies), ISO9001 (5 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Orlistat (CAS 96829-58-2) used for?
Orlistat is used for the management of obesity in adults by inhibiting gastrointestinal lipases and reducing dietary fat absorption. It supports weight reduction and maintenance when combined with a calorie‑restricted diet, and the 120 mg prescription strength is also indicated to reduce the risk of weight regain after prior weight loss. In some regions, a 60 mg formulation is available for nonprescription use.
Which therapeutic class does Orlistat fall into?
Orlistat belongs to the following therapeutic categories: Alimentary Tract and Metabolism, Anti-Obesity Agents, Antiobesity Preparations, Excl. Diet Products, Cytochrome P-450 CYP3A Inducers, Cytochrome P-450 CYP3A4 Inducers. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Orlistat mainly prescribed for?
The primary indications for Orlistat: Orlistat is indicated for obesity management including weight loss and weight maintenance when used in combination with calorie reduction in overweight and obese adults, This indication applies to both the prescription formulation of 120 mgand the over-the-counter formulation of 60 mg, Orlistat in the 120 mg prescription formulation is also indicated to reduce the risk of weight regain following weight loss. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Orlistat work?
Orlistat is a potent and selective inhibitor of various lipase enzymes responsible for the metabolism of fat. It acts in the gastrointestinal (GI) tract via covalent binding to the serine residues located on the active site of both gastric and pancreatic lipase. When Orlistat is taken with food containing fat, it partially inhibits the hydrolysis of triglycerides. This decreases absorption of monoaclglycerides and free fatty acids, contributing to weight maintenance and weight loss.
What should someone know about the safety or toxicity profile of Orlistat?
Orlistat has low systemic toxicity because it is minimally absorbed, and acute toxicity studies show an oral LD50 in rats above 5000 mg/kg. Its safety profile is dominated by gastrointestinal effects such as steatorrhea and oily spotting, which reflect unabsorbed dietary fat. Rare cases of severe liver injury, oxalate‑related kidney injury, and reduced absorption of fat‑soluble vitamins have been reported. Handling the API mainly requires avoiding unnecessary exposure to high dust levels.
What are important formulation and handling considerations for Orlistat as an API?
Key considerations include managing Orlistat’s very low aqueous solubility and high lipophilicity by using lipid‑based or dispersion systems to support adequate dissolution. Its waxy, hydrophobic nature requires controlled handling to minimize moisture exposure and ensure uniform blend dispersion during manufacture. Solid‑state stability is generally good, and formulations should account for food dependence, as co‑ingested fat enhances luminal dispersion and activity.
Is Orlistat a small molecule?
Orlistat is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Orlistat?
Oral Orlistat is generally solid‑state stable, but its waxy, highly lipophilic nature requires controlling moisture and ensuring uniform dispersion during manufacturing. Its extremely low aqueous solubility means formulation approaches must maintain adequate dispersion to support dissolution in the gastrointestinal lumen. Because food fat enhances dispersion and activity, stability and performance can be sensitive to conditions that alter its lipid‑based presentation.
Regulatory
Where is Orlistat approved or in use globally?
Orlistat is reported as approved in the following major regions: US, EU, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Orlistat right now?
Orlistat is approved for use in the United States, European Union, and Canada. It is widely available as a generic drug, indicating that original patent protections and exclusivities have lapsed. Regulatory oversight in these regions focuses on quality, safety, and bioequivalence standards for both branded and generic products.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Orlistat procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Orlistat. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Orlistat included in the PRO Data Insights coverage?
PRO Data Insights coverage for Orlistat: 1447 verified transactions across 308 suppliers and 208 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Orlistat?
Market report availability for Orlistat: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
