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Pantoprazole | CAS No: 102625-70-7 | GMP-certified suppliers
A medication that manages GERD‑related erosive esophagitis, supports ongoing healing, and treats long‑term pathological hypersecretory conditions such as Zollinger‑Ellison syndrome for diverse clinical needs.
Therapeutic categories
Primary indications
- Pantoprazole Injection**:
- Treatment of gastroesophageal reflux disease associated with a history of erosive esophagitis**
- Pantoprazole for injection is indicated for short-term treatment (7-10 days) of patients having gastroesophageal reflux disease (GERD) with a history of erosive esophagitis, as an alternative to oral medication in patients who are unable to continue taking pantoprazole delayed-release tablets
- _Safety and efficacy of pantoprazole injection as the initial treatment of patients having GERD with a history of erosive esophagitis have not been demonstrated at this time_
Product Snapshot
- Pantoprazole is available as an oral delayed‑release small‑molecule formulation and as a parenteral injectable powder for solution
- It is used for GERD with erosive esophagitis, maintenance of healed esophagitis, and pathological hypersecretory conditions such as Zollinger‑Ellison syndrome
- It is an approved API in major regulated markets including the US, EU, and Canada
Clinical Overview
Pantoprazole suppresses gastric acid secretion through irreversible inhibition of the H+,K+-ATPase located on gastric parietal cells. After accumulation in the acidic canaliculi, pantoprazole is converted to an active sulfenamide that forms covalent bonds with cysteine residues on the proton pump. This mechanism blocks the final pathway of gastric acid production, producing long‑lasting inhibition independent of stimulus.
Pantoprazole reduces basal and stimulated acid secretion, improves symptoms of acid reflux, and supports mucosal healing. Gastrin levels typically rise during therapy due to feedback mechanisms. Proton pump inhibitors may interfere with chromogranin A testing and can cause false‑positive urine THC screens.
Pantoprazole is rapidly absorbed as a weak base and undergoes hepatic metabolism primarily via CYP2C19 and CYP3A pathways. It is eliminated mainly as metabolites in urine. Pharmacokinetics may vary with CYP2C19 polymorphisms. The duration of effect exceeds 24 hours because activity resumes only after new enzyme synthesis.
Safety considerations include potential long‑term risks such as micronutrient malabsorption, hypomagnesemia, hypocalcemia, increased susceptibility to certain infections including C. difficile, and possible associations with elevated ADMA levels due to DDAH inhibition. Tapering is recommended to minimize rebound acid hypersecretion when discontinuing therapy.
For API procurement, suppliers must provide evidence of compliance with pharmacopoeial specifications, control of benzimidazole‑related impurities, and robust stability data to ensure consistent performance across oral and parenteral formulations.
Identification & chemistry
| Generic name | Pantoprazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 102625-70-7 |
| UNII | D8TST4O562 |
| DrugBank ID | DB00213 |
Pharmacology
| Summary | Pantoprazole is a proton pump inhibitor that targets the gastric H+/K+-ATPase in parietal cells, where it is converted to an active sulfenamide that forms disulfide bonds with the pump to block the final step of acid secretion. This inhibition produces sustained suppression of gastric acid output and secondary increases in gastrin levels. Pantoprazole also interacts with dimethylarginine dimethylaminohydrolase, which can influence nitric‑oxide–related pathways. |
|---|---|
| Mechanism of action | Hydrochloric acid (HCl) secretion into the gastric lumen is a process regulated mainly by the H(+)/K(+)-ATPase of the proton pump, expressed in high quantities by the parietal cells of the stomach.ATPase is an enzyme on the parietal cell membrane that facilitates hydrogen and potassium exchange through the cell, which normally results in the extrusion of potassium and formation of HCl (gastric acid). Proton pump inhibitors such as pantoprazole are substituted _benzimidazole_ derivatives, weak bases, which accumulate in the acidic space of the parietal cell before being converted in the _canaliculi_ (small canal) of the gastric parietal cell, an acidic environment, to active _sulfenamide_ derivatives. This active form then makes disulfide bonds with important cysteines on the gastric acid pump, inhibiting its function.Specifically, pantoprazole binds to the _sulfhydryl group_ of H+, K+-ATPase, which is an enzyme implicated in accelerating the final step in the acid secretion pathway. The enzyme is inactivated, inhibiting gastric acid secretion.The inhibition of gastric acid secretion is stronger with proton pump inhibitors such as pantoprazole and lasts longer than with the H(2) antagonists. |
| Pharmacodynamics | This drug acts to decrease gastric acid secretion, which reduces stomach acidity. Pantoprazole administration leads to long-lasting inhibition of gastric acid secretion. **General Effects** Pantoprazole has been shown to reduce acid reflux-related symptoms, heal inflammation of the esophagus, and improve patient quality of life more effectively than histamine-2 receptor antagonists (H2 blockers). This drug has an excellent safety profile and a low incidence of drug interactions. It can be used safely in various high-risk patient populations, including the elderly and those with renal failure or moderate hepatic dysfunction. Due to their good safety profile and as several PPIs are available over the counter without a prescription, their current use in North America is widespread. Long term use of PPIs such as pantoprazole have been associated with possible adverse effects, however, including increased susceptibility to bacterial infections (including gastrointestinal _C. difficile_), reduced absorption of micronutrients including iron and B12, and an increased risk of developing hypomagnesemia and hypocalcemia which may contribute to osteoporosis and bone fractures later in life. PPIs such as pantoprazole have also been shown to inhibit the activity of dimethylarginine dimethylaminohydrolase (DDAH), an enzyme necessary for cardiovascular health. DDAH inhibition causes a consequent accumulation of the nitric oxide synthase inhibitor asymmetric dimethylarginie (ADMA), which is thought to cause the association of PPIs with increased risk of cardiovascular events in patients with unstable coronary syndromes . **A note on laboratory testing abnormalities** During treatment with antisecretory medicinal products such as pantoprazole, serum gastrin (a peptide hormone that stimulates secretion of gastric acid) increases in response to the decreased acid secretion caused by proton pump inhibition. The increased gastrin level may interfere with investigations for neuroendocrine tumors. Published evidence suggests that proton pump inhibitors should be stopped 14 days before chromogranin A (CgA) measurements. This permits chromogranin A levels, that might be falsely elevated after proton pump inhibitor treatment, to return to the normal reference range. Reports have been made of false-positive results in urine screening tests for tetrahydrocannabinol (THC) in patients receiving the majority of proton pump inhibitors, including pantoprazole. A confirmatory method should be used. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Potassium-transporting ATPase alpha chain 1 | Humans | inhibitor |
| N(G),N(G)-dimethylarginine dimethylaminohydrolase 1 | Humans | inhibitor |
ADME / PK
| Absorption | Pantoprazole is absorbed after oral administration as an enteric-coated tablet with maximum plasma concentrations attained within 2 – 3 hours and a bioavailability of 77% that does not change with multiple dosing . Following an oral dose of 40mg, the Cmax is approximately 2.5 μg/mL with a tmax of 2 to 3 hours. The AUC is approximately 5 μg.h/mL. There is no food effect on AUC (bioavailability) and Cmax. Delayed-release tablets are prepared as enteric-coated tablets so that absorption of pantoprazole begins only after the tablet leaves the stomach. |
|---|---|
| Half-life | About 1 hour |
| Protein binding | Approximately 98%[FDA label] |
| Metabolism | Pantoprazole is heavily metabolized in the liver by the cytochrome P450 (CYP) system. Pantoprazole metabolism is independent of the route of administration (intravenous or oral). The main metabolic pathway is _demethylation_, by _CYP2C19_ hepatic cytochrome enzyme, followed by sulfation; other metabolic pathways include oxidation by CYP3A4. There is no evidence that any of the pantoprazole metabolites are pharmacologically active. After hepatic metabolism, almost 80% of an oral or intravenous dose is excreted as metabolites in urine; the remainder is found in feces and originates from biliary secretion. |
| Route of elimination | After a single oral or intravenous (IV) dose of 14C-labeled pantoprazole to healthy, normal metabolizing subjects, about 71% of the dose was excreted in the urine, with 18% excreted in the feces by biliary excretion. There was no kidney excretion of unchanged pantoprazole. |
| Volume of distribution | The apparent volume of distribution of pantoprazole is approximately 11.0-23.6 L, distributing mainly in the extracellular fluid.[FDA label] |
| Clearance | **Adults**: With intravenous administration of pantoprazole to extensive metabolizers, total clearance is 7.6-14.0 L/h. In a population pharmacokinetic analysis, the total clearance increased with increasing body weight in a non-linear fashion. **Children**: clearance values in the children 1 to 5 years old with endoscopically proven GERD had a median value of 2.4 L/h. |
Formulation & handling
- Pantoprazole is a small‑molecule PPI requiring acid‑stable oral formulations such as enteric‑coated tablets, granules, or capsules to prevent degradation in gastric fluid.
- Low aqueous solubility and acid lability influence excipient selection, with alkaline microenvironments commonly used to protect the API and support dissolution.
- Parenteral products rely on lyophilized powder or buffered solutions to maintain stability, with reconstitution and handling conditions designed to limit pH‑driven degradation.
Regulatory status
| Lifecycle | Key U.S. and Canadian patents have expired, with the most recent Canadian protection ending in 2021, indicating the API is in a mature stage with broad generic availability. The product is established across Canada, the EU, and the US, reflecting a well‑developed post‑patent market. |
|---|
| Markets | Canada, EU, US |
|---|
Supply Chain
| Supply chain summary | Pantoprazole originated with a small group of innovator companies, but the market is now dominated by numerous global generic manufacturers and packagers. Branded and generic products are widely established across the US, EU, and Canada, indicating mature global distribution. Patent expiries in both the US and Canada occurred years ago, supporting the presence of extensive existing generic competition. |
|---|
Safety
| Toxicity | **Rat Oral LD 50** 747 mg/kg **Tumorigenicity** Because of the chronic nature of GERD, there may be a potential for long-term administration of pantoprazole. In long-term rodent studies, pantoprazole was carcinogenic and its administration lead to rare types of gastrointestinal tumors. The relevance of these findings to tumor development in humans is unknown at this time. **Teratogenic Effects** This drug falls under pregnancy category B category. Reproduction studies have been performed in rats at oral doses up to 88 times the recommended human dose (RHD), as well as in rabbits at oral doses up to 16 times the RHD, and have shown no evidence of impaired fertility or harm to the fetus caused by pantoprazole. No adequate and well-controlled studies in pregnant women have been completed. Because animal reproduction studies are not always predictive of human response, this drug should only be used during pregnancy if clearly required. **Nursing Mothers** Pantoprazole and its metabolites have been found to be excreted in the milk of rats. Pantoprazole excretion in human milk has been found in a study performed with a single nursing mother after one 40 mg oral dose. The clinical relevance of this finding is not known, however, it is advisable to take note of this finding when considering pantoprazole use during nursing. Many drugs excreted in human breastmilk have a risk for serious adverse effects in nursing infants. |
|---|
- Rat oral LD50 of 747 mg/kg indicates moderate acute toxicity, warranting standard controls for handling and accidental exposure
- Chronic rodent studies identified carcinogenicity and rare gastrointestinal tumors during long-term administration
- Relevance to humans remains undetermined
Pantoprazole 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.
Pantoprazole (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.
Pantoprazole API manufacturers & distributors
Compare qualified Pantoprazole API suppliers worldwide. We currently have 45 companies offering Pantoprazole API, with manufacturing taking place in 10 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 |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, GMP, ISO9001, MSDS, USDMF | 250 products |
| BIOGEN PHARMACEUTICAL CO. | Producer | India | India | CoA, EDMF/ASMF, GMP, USDMF, WHO-GMP | 1 products |
| Chemport Bangladesh | Distributor | Bangladesh | India | CoA, GMP, ISO9001, USDMF | 1 products |
| Cipla | Producer | India | India | CEP, CoA, USDMF, WC | 164 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Dr. Sahu's Laboratories | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, MSDS | 70 products |
| Emcure Pharma | Producer | India | India | CoA, USDMF | 80 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hetero Drugs | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 98 products |
| Isochem | Producer | France | France | CEP, CoA, FDA, GMP, USDMF | 12 products |
| Jinan Mingxin | Producer | China | China | CoA, WC | 7 products |
| Jinzhou Jiutai | Producer | China | China | CoA, USDMF | 3 products |
| Kleem Pharmaceuticals | Producer | India | India | CoA | 22 products |
| KRKA | Producer | Slovenia | Unknown | CEP, CoA, GMP | 81 products |
| Laurus Labs | Producer | India | India | CoA, GMP, WC | 50 products |
| Lee Pharma | Producer | India | India | CEP, CoA, FDA, GMP, ISO9001, 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, USDMF | 155 products |
| Mac Chem Products | Producer | India | India | CoA, GMP, WC | 25 products |
| Medichem | Producer | Spain | Unknown | CEP, CoA, FDA, GMP | 39 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, USDMF | 50 products |
| MSN Labs. | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 119 products |
| Mylan | Producer | India | India | CEP, CoA, USDMF, WC | 201 products |
| Natco Pharma | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 40 products |
| PMC Isochem | Producer | France | Unknown | CEP, CoA, GMP | 7 products |
| Quimica Sintetica | Producer | Spain | Unknown | CEP, CoA, GMP, USDMF | 51 products |
| Rajasthan Antibiotics | Producer | India | India | CoA, WC | 9 products |
| Raks Pharma | Producer | India | India | CoA, USDMF | 58 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Rpg Life Sciences | Producer | India | India | CoA, GMP, WC | 13 products |
| Sandoz | Producer | Austria | Turkey | CEP, CoA, FDA, GMP | 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 | CEP, CoA, GMP, ISO9001, USDMF | 757 products |
| Srini Pharma | Producer | India | India | CoA, USDMF | 12 products |
| Sterile India | Producer | India | India | CoA, ISO9001, USDMF, WC, WHO-GMP | 13 products |
| Sun Pharma | Producer | India | India | CEP, CoA, USDMF, WC | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Vasudha Pharma Chem Ltd. | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, MSDS, USDMF, WC | 37 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 134 products |
| Zydus Takeda Healthcare | Producer | India | India | CoA, WC | 7 products |
When sending a request, specify which Pantoprazole 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 Pantoprazole 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 Pantoprazole API
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Technical
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Regulatory
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