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Lansoprazole | CAS No: 103577-45-3 | GMP-certified suppliers
A medication that treats acid‑related gastrointestinal disorders by supporting healing of gastric and duodenal ulcers, reflux disease, esophagitis, and aiding H. pylori eradication.
Therapeutic categories
Primary indications
- Lansoprazole is used to reduce gastric acid secretion and is approved for short term treatment of active gastric ulcers, active duodenal ulcers, erosive reflux oesophagitis, symptomatic gastroesophageal reflux disease, and non-steroidal anti-inflammatory drug (NSAID) induced gastric and duodenal ulcers
- [FDA Label] It may be used in the maintenance and healing of several gastric conditions including duodenal ulcers, NSAID related gastric ulcers, and erosive esophagitis
- [FDA Label] Lansoprazole prevents recurrence of gastric ulcers in patients who have a documented history of gastric ulcers who also use NSAIDs chronically
- [FDA Label] Predictably, it is also useful in the management of hypersecretory conditions including Zollinger-Ellison syndrome
Product Snapshot
- Lansoprazole is a proton pump inhibitor available mainly as oral delayed‑release solid-dose formulations with some injectable presentations for IV use
- It is used for acid‑related gastric and esophageal disorders, including ulcer management, reflux disease, NSAID‑associated ulceration, hypersecretory conditions, and as a component of H
- Pylori eradication regimens
Clinical Overview
Lansoprazole reduces gastric acid secretion by inhibiting the parietal cell H+,K+-ATPase, the terminal step in acid production. It provides inhibition throughout daytime and nocturnal periods, contributing to ulcer healing and symptom relief. Reduction of pepsin output also contributes to its therapeutic activity in hypersecretory states.
As a prodrug, lansoprazole requires protonation in an acidic environment to form active sulfenamide intermediates. These intermediates covalently bind cysteine residues, particularly Cys813 and Cys321, on the H+,K+-ATPase, generating stable disulfide bonds that produce prolonged suppression of acid secretion until new enzyme is synthesized.
Lansoprazole undergoes hepatic metabolism involving several cytochrome P450 pathways, with CYP2C19 and CYP3A enzymes contributing substantially. It acts as both a substrate and an inhibitor or inducer of multiple CYP isoforms, and it also interacts with transporters including P‑glycoprotein, BCRP, and OAT3. These characteristics create potential for clinically relevant drug interactions depending on co‑medications and patient metabolic phenotype.
Safety considerations include dose‑dependent gastric pH elevation, which may influence the absorption of pH‑sensitive drugs. Long‑term use considerations include effects associated with chronic acid suppression. Toxicity profiles are consistent with the proton pump inhibitor class.
For API procurement, suppliers should provide evidence of consistent polymorphic form control, validated stability data, and compliance with pharmacopoeial and regional regulatory standards to support formulation development and global registration.
Identification & chemistry
| Generic name | Lansoprazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 103577-45-3 |
| UNII | 0K5C5T2QPG |
| DrugBank ID | DB00448 |
Pharmacology
| Summary | Lansoprazole is a proton pump inhibitor prodrug that becomes activated in acidic conditions and forms covalent bonds with cysteine residues on the gastric H+,K+-ATPase, producing sustained suppression of proton transport. This inhibition reduces gastric acid and associated pepsin secretion, supporting control of acid‑driven gastrointestinal disorders and hypersecretory states. The drug’s activity is centered on durable blockade of parietal‑cell proton pumps, with secondary interactions reported for other protein targets such as tau. |
|---|---|
| Mechanism of action | As a PPI, lansoprazole is a prodrug and requires protonation via an acidic environment to become activated. Once protonated, lansoprazole is able to react with cysteine residues, specifically Cys813 and Cys321, on parietal H+,K+-ATPase resulting in stable disulfides.PPI's in general are able to provide prolonged inhibition of acid secretion due to their ability to bind covalently to their targets. |
| Pharmacodynamics | Lansoprazole decreases gastric acid secretion by targeting H+,K+-ATPase, which is the enzyme that catalyzes the final step in the acid secretion pathway in parietal cells. Conveniently, lansoprazole administered any time of day is able to inhibit both daytime and nocturnal acid secretion.The result is that lansoprazole is effective at healing duodenal ulcers, reduces ulcer-related pain, and offers relief from symptoms of heartburn Lansoprazole also reduces pepsin secretion, making it a useful treatment option for hypersecretory conditions such as Zollinger-Ellison syndrome. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Potassium-transporting ATPase alpha chain 1 | Humans | inhibitor |
| Microtubule-associated protein tau | Humans |
ADME / PK
| Absorption | The oral bioavailability of lansoprazole is reported to be 80-90%and the peak plasma concentration(Cmax) is achieved about 1.7 hours after oral dosing.[FDA Label] Food reduces the absorption of lansoprazole (both Cmax and AUC are reduced by 50-70%); therefore, patients should be instructed to take lansoprazole before meals.[FDA Label] |
|---|---|
| Half-life | One source reports the half life of lansoprazole to be 0.9 - 1.6 hours, while another source cites 0.9 - 2.1 hours. The general consensus is that lansoprazole has a short half life and is approximately 2 hours or less. [FDA Label] These numbers may be misleading since it suggests that lansoprazole has a short duration of action when in practice, lansoprazole can effectively inhibit acid secretion for ~24 hours due to it's mechanism of action. [FDA Label] |
| Protein binding | 97% of lansoprazole is plasma protein bound. [FDA Label] |
| Metabolism | Lansoprazole is predominantly metabolized in the liver by CYP3A4 and CYP2C19. The resulting major metabolites are 5-hydroxy lansoprazole and the sulfone derivative of lansoprazole. [FDA Label] |
| Route of elimination | A reported 14-23% of a lansoprazole is eliminated in the urine with this percentage range including both conjugated and unconjugated hydroxylated metabolites. |
| Volume of distribution | The apparent volume of distribution of lansoprazole is 0.4 L/kg. |
| Clearance | The reported clearance of lansoprazole is 400-650 mL/min. |
Formulation & handling
- Lansoprazole is an orally administered small molecule that requires acid‑protected formulations (e.g., enteric‑coated pellets or delayed‑release matrices) due to rapid degradation in low‑pH environments.
- Low aqueous solubility and moderate lipophilicity support use of multiparticulate or buffered systems to enhance stability and dissolution in the upper GI tract.
- IV presentations rely on reconstitution of the solid powder with appropriate pH control to maintain stability of the sulfinylbenzimidazole moiety.
Regulatory status
| Lifecycle | Most US patents for the API expired between 2009 and 2019, with the remaining Canadian protection ending in 2021, indicating that exclusivity has lapsed in both markets. The product is therefore in a mature lifecycle phase in the US and Canada, where generic competition would be expected. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Lansoprazole was originally developed by an originator company, but its key US and Canadian patents have long expired, enabling broad generic manufacturing by multiple international producers and extensive repackaging activity. Branded and generic products are established in the US and Canada, with wide market penetration across both regions. Patent expiry dates indicate that generic competition is well‑established and ongoing. |
|---|
Safety
| Toxicity | The most commonly reported adverse events occurring more frequently in lansoprazole treated patients compared to placebo include abdominal pain, constipation, diarrhea, and nausea.[FDA Label] There is a case report of toxic epidermal necrolysis (TEN), which is a rare but very serious cutaneous reaction, caused by lansoprazole.The previously healthy patient presented with symptoms of TEN 15 days after starting lansoprazole to manage peptic disease.Although the use of PPI's is rarely associated with TEN, causation should be considered if a patient presents with TEN shortly after newly commencing a PPI. In a single case report, a patient ingested 600 mg of lansoprazole and did not experience any adverse effects or symptoms of overdose.[FDA Label] Overall, lansoprazole is well tolerated with relatively few adverse effects. Lansoprazole is classified as Pregnancy Category B.[FDA Label] Although there are animal studies that suggest lansoprazole does not cause harm to the fetus, there is still a paucity of human data. Hence, lansoprazole should only be administered to pregnant women if other options with more safety data have been exhausted. It is unknown if lansoprazole is excreted in human breast milk.[FDA Label] It is worth mentioning that lansoprazole has been used safely in infants, and is therefore likely safe to use during breastfeeding. |
|---|
- Gastrointestinal effects such as abdominal pain, constipation, diarrhea, and nausea occur more frequently relative to placebo exposure
- Rare severe cutaneous reactions, including toxic epidermal necrolysis, have been documented in isolated case reports
- High‑dose exposure up to 600 mg in a single reported instance produced no observable overdose symptoms, indicating a wide acute‑toxicity margin
Lansoprazole is a type of Proton pump inhibitors
Proton pump inhibitors (PPIs) are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) commonly used for the treatment of gastroesophageal reflux disease (GERD), peptic ulcers, and other acid-related gastrointestinal conditions. PPIs work by inhibiting the gastric proton pump, which is responsible for the secretion of stomach acid.
The primary mechanism of PPIs involves blocking the final step in acid production, thereby reducing the amount of acid produced in the stomach. This inhibition occurs by binding irreversibly to the hydrogen-potassium ATPase enzyme system, also known as the proton pump, located on the parietal cells of the stomach lining. By reducing the acid levels, PPIs provide relief from the symptoms of acid reflux, such as heartburn and regurgitation, while promoting the healing of ulcers.
PPIs are available in various formulations, including delayed-release capsules, tablets, and oral suspensions. Some commonly prescribed PPIs include omeprazole, lansoprazole, pantoprazole, and esomeprazole. These medications are typically taken orally, with the dosage and duration of treatment determined by the severity of the condition and the individual patient's needs.
It is important to note that PPIs are intended for short-term use, generally ranging from four to eight weeks. Prolonged use of PPIs may lead to potential side effects, including an increased risk of gastrointestinal infections, vitamin and mineral deficiencies, and bone fractures.
In summary, proton pump inhibitors are a widely used subcategory of pharmaceutical APIs that effectively reduce stomach acid production. While they provide relief from acid-related conditions, careful consideration of their appropriate usage and potential side effects is necessary for optimal patient care.
Lansoprazole (Proton pump inhibitors), 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.
Lansoprazole API manufacturers & distributors
Compare qualified Lansoprazole API suppliers worldwide. We currently have 31 companies offering Lansoprazole API, with manufacturing taking place in 12 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 |
|---|---|---|---|---|---|
| Alkem Labs. | Producer | India | India | CoA, USDMF, WC | 22 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 250 products |
| Chemo Iberica | Producer | Spain | Spain | CEP, CoA, USDMF | 12 products |
| Cipla | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 164 products |
| Daewoong Bio | Producer | South Korea | South Korea | CoA, JDMF | 12 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Guangzhou Winsun | Producer | China | China | CEP, CoA | 1 products |
| Guilin Hwasun Pharmaceuti... | Producer | China | China | CEP, CoA, GMP, WC | 2 products |
| Hetero Drugs | Producer | India | Unknown | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 98 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| Lee Pharma | Producer | India | India | CEP, CoA, FDA, GMP, ISO9001, KDMF, USDMF, WC, WHO-GMP | 21 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, JDMF, Other, KDMF, USDMF | 50 products |
| Murli Krishna Pharma Pvt.... | Producer | India | India | CoA, USDMF | 7 products |
| Mylan | Producer | India | India | CEP, CoA, JDMF, USDMF, WC | 201 products |
| Natco Pharma | Producer | India | India | CoA, FDA, GMP, USDMF, WC | 40 products |
| Prochem Pharmtech Co., Lt... | Producer | Taiwan | Taiwan | BSE/TSE, CoA, MSDS | 2 products |
| Quimica Sintetica | Producer | Spain | Unknown | CEP, CoA, GMP | 51 products |
| Recordati S.p.A. | Producer | Italy | Italy | CoA, GMP, JDMF | 18 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Sandoz | Producer | Austria | India | CEP, CoA, FDA, GMP, WC | 58 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shouguang Fukang | Producer | China | Unknown | CEP, CoA, FDA, USDMF, WC | 13 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, USDMF, WC | 757 products |
| Sun Pharma | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 219 products |
| Syn-tech Chem | Producer | Taiwan | Taiwan | CoA, JDMF, USDMF | 22 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 133 products |
| WATERSTONE PHARMACEUTICAL... | Producer | China | China | CoA, USDMF | 4 products |
| Zhuhai Rundu | Producer | China | China | CoA, WC | 11 products |
When sending a request, specify which Lansoprazole 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 Lansoprazole 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 Lansoprazole API
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