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Ranitidine hydrochloride (Ranitidine) API Manufacturers & Suppliers
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Ranitidine | CAS No: 66357-35-5 | GMP-certified suppliers
A medication that reduces gastric acid secretion for the treatment and maintenance of duodenal and gastric ulcers, GERD symptoms, erosive esophagitis, and acid hypersecretion disorders.
Therapeutic categories
Primary indications
- This drug is used alone or with concomitant antacids for the following conditions: short-term treatment of active duodenal ulcer, treating gastric acid hypersecretion due to Zollinger-Ellison syndrome, systemic mastocytosis, and other conditions that may pathologically raise gastric acid levels
- It also used in the short term treatment of active benign gastric ulcers and maintenance therapy of gastric ulcers at a reduced dose
- In addition to the above, ranitidine can be used for the treatment of GERD symptoms, treatment of erosive esophagitis (endoscopically diagnosed) and the maintenance of gastric or duodenal ulcer healing
Product Snapshot
- Ranitidine is available primarily as an oral small molecule in various tablet forms, syrup, and injectable solutions
- It is used mainly for the short-term treatment of duodenal and gastric ulcers, gastric acid hypersecretion conditions like Zollinger-Ellison syndrome, and gastroesophageal reflux disease (GERD)
- Ranitidine has received regulatory approval in the US and Canada but has also been withdrawn in certain markets
Clinical Overview
Pharmacodynamically, ranitidine decreases gastric acid secretion stimulated by food intake as well as by drugs and disease states that increase acid production. Endoscopic assessments have demonstrated marked improvements in esophageal mucosal integrity following ranitidine therapy.
The mechanism of action involves the reversible inhibition of histamine H2 receptors located on gastric parietal cells. Normally, gastrin released postprandially stimulates histamine release, which binds to these receptors and triggers gastric acid secretion. Ranitidine blocks this receptor binding, thereby reducing acid output. Symptom relief can begin within 60 minutes after dosing, with effects lasting between 4 and 10 hours.
Ranitidine undergoes metabolism involving cytochrome P450 enzymes and is known to interact as both substrate and inhibitor of various CYP isoforms, including CYP1A2, CYP2D6, and CYP3A4, which may necessitate consideration of drug interactions. The compound is largely excreted renally. Safety profiles require vigilance for potential adverse effects, including muscle toxicity and altered metabolic pathways, although the drug is generally well-tolerated.
Ranitidine has been marketed under the brand name Zantac among others, available as tablets, injections, and effervescent tablets. Regulatory status varies globally, with some markets having withdrawn ranitidine due to concerns related to impurities.
For API sourcing, quality assurance is critical to ensure compliance with pharmacopeial standards and regulatory guidelines, particularly controls on impurities such as nitrosamines. Procurement should prioritize manufacturers with validated quality systems, appropriate documentation, and responsiveness to regulatory updates affecting ranitidine use worldwide.
Identification & chemistry
| Generic name | Ranitidine |
|---|---|
| Molecule type | Small molecule |
| CAS | 66357-35-5 |
| UNII | 884KT10YB7 |
| DrugBank ID | DB00863 |
Pharmacology
| Summary | Ranitidine acts as a reversible antagonist of histamine H2 receptors on gastric parietal cells, inhibiting histamine-induced gastric acid secretion. It reduces gastric acid production in conditions such as Zollinger-Ellison syndrome and gastroesophageal reflux disease by blocking receptor-mediated stimulation of acid secretion. This mechanism leads to decreased gastric acidity, facilitating mucosal healing and symptom relief in acid-related disorders. |
|---|---|
| Mechanism of action | After a meal, the hormone gastrin, produced by cells in the lining of the stomach, stimulates the release of histamine, which then binds to histamine H2 receptors, leading to the secretion of gastric acid. Ranitidine reduces the secretion of gastric acid by reversible binding to histamine (H2) receptors, which are found on gastric parietal cells. This process leads to the inhibition of histamine binding to this receptor, causing the reduction of gastric acid secretion. The relief of gastric-acid related symptoms can occur as soon as 60 minutes after administration of a single dose, and the effects can last from 4-10 hours, providing fast and effective symptomatic relief. |
| Pharmacodynamics | Ranitidine decreases the secretion of gastric acid stimulated by food and drugs. It also reduces the secretion of gastric acid in hypersecretory conditions such as Zollinger-Ellison syndrome. Marked improvements in the appearance of the esophageal tissues have been observed by endoscopic imaging after ranitidine therapy. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Histamine H2 receptor | Humans | antagonist |
| Acetylcholinesterase | Humans | inhibitor |
ADME / PK
| Absorption | Ranitidine is rapidly absorbed with peak concentrations reached within 1-3 hours after administration, and varying greatly among patients. Bioavailability is about 50%-60% due to hepatic metabolism. In a pharmacokinetic study of healthy males, the AUC 0-infinity was about 2,488.6 ng x h/mL and the median Tmax was 2.83 hours. Food or antacids have limited effects on absorption. One clinical study found that the administration of a potent antacid (150 mmol) in subjects in the fasted state led to decreased absorption of ranitidine. |
|---|---|
| Half-life | The elimination half-life or ranitidine is about 2.5-3 hours. It may be longer after oral administration versus injection. The plasma half-life is longer for elderly patients population due to a decrease in renal function, and is measured at 3-4 hours. |
| Protein binding | The plasma protein binding of ranitidine is approximately 15%. |
| Metabolism | The major metabolite in the urine is N-oxide, which represents less than 4% of the dose. Other metabolites of ranitidine include S-oxide (1%) and desmethyl ranitidine (1%). The feces contain the remainder of the excreted ranitidine dose. Liver dysfunction has been shown to cause small, but clinically insignificant, changes in various ranitidine pharmacokinetic parameters. |
| Route of elimination | This drug is mainly excreted in the urine but also excreted in the feces. About 30% of a single oral dose has been measured in the urine as unchanged drug within 24 hours of ingestion. |
| Volume of distribution | The volume of distribution is higher than body volume, and measures at approximately 1.4 L/kg. It concentrates in breast milk, but does not readily distribute into the cerebrospinal fluid. |
| Clearance | Renal clearance is about 410 mL/min according to FDA prescribing information. Another resource mentions a plasma clearance of approximately 600 ml/min. Clearance is decreased in the elderly and those with impaired or hepatic renal function. It is recommended to decrease the dose of ranitidine by one-half in patients with renal impairment. |
Formulation & handling
- Ranitidine is a small molecule API available for oral, intravenous, and intramuscular administration, supporting both solid and liquid formulations.
- The API exhibits low water solubility, which should be considered in formulation design, especially for parenteral solutions.
- Ranitidine absorption is not affected by food, allowing flexible dosing relative to meals.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) has patents that expired between 2009 and 2011 in the United States and Canada, indicating it is in a mature market phase with generic availability in these regions. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for ranitidine includes multiple originator and generic pharmaceutical companies with a significant presence in the US and Canadian markets. Branded ranitidine products are marketed primarily in North America, supported by a broad supply chain of manufacturers and packagers. Patent expirations in the US and Canada suggest that generic competition is well established or forthcoming in these regions. |
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Safety
| Toxicity | Oral doses of 1,000 mg/kg in mice and rats were not found to be lethal. Intravenous LD50 values in mice and rats were 77 and 83 mg/kg, respectively. Overdose information There has been limited experience with ranitidine overdose. Reported acute ingestions of up to 18 grams orally were followed by temporary adverse effects similar to the normal adverse effects of this drug, including tachycardia, bradycardia, dizziness, diarrhea, nausea, and vomiting, among other effects. Gait abnormalities and hypotension have also been observed. When an overdose with ranitidine is suspected, remove unabsorbed ranitidine from the gastrointestinal tract if possible, and monitor the patient and provide supportive therapy as required. |
|---|
- Intravenous administration shows high acute toxicity with LD50 values of 77 mg/kg in mice and 83 mg/kg in rats
- Oral doses up to 1,000 mg/kg in rodents did not result in lethality, indicating lower systemic toxicity via oral route
- Overdose may cause cardiovascular and neurological effects including tachycardia, bradycardia, gait abnormalities, and hypotension
Ranitidine is a type of H2 antagonists
H2 antagonists, also known as histamine H2 receptor antagonists, are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the treatment of various gastrointestinal disorders. These medications work by blocking the H2 receptors located on the surface of the stomach's parietal cells, thereby reducing the production of gastric acid.
H2 antagonists are commonly prescribed to alleviate symptoms associated with conditions like gastroesophageal reflux disease (GERD), peptic ulcers, and gastritis. By inhibiting the action of histamine on the H2 receptors, these drugs effectively suppress the secretion of gastric acid, leading to decreased acidity in the stomach.
One of the notable benefits of H2 antagonists is their ability to provide longer-lasting relief compared to other acid-reducing medications. They offer significant advantages over their predecessors, such as antacids, by not only providing symptomatic relief but also promoting the healing of underlying gastric ulcers.
Some widely recognized H2 antagonists include cimetidine, ranitidine, famotidine, and nizatidine. These APIs are typically formulated into various dosage forms, including tablets, capsules, and injectable solutions, to cater to different patient needs.
Due to their efficacy and widespread use, H2 antagonists have become an essential component of many treatment regimens targeting acid-related gastrointestinal disorders. However, it is important to note that these medications may have potential side effects and drug interactions, so they should be used under medical supervision and in accordance with prescribed guidelines. Consulting a healthcare professional is recommended for proper evaluation and appropriate usage of H2 antagonist medications.
Ranitidine (H2 antagonists), 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.
Ranitidine API manufacturers & distributors
Compare qualified Ranitidine API suppliers worldwide. We currently have 11 companies offering Ranitidine 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 |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| CSPC Zhongnuo | Producer | China | China | CEP, CoA, FDA | 6 products |
| Duchefa Farma B.V. | Distributor | Netherlands | India | CoA, GMP, ISO9001, MSDS | 170 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Orchev Pharma | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 1 products |
| Quimica Sintetica | Producer | Spain | Unknown | CoA, JDMF | 51 products |
| Saraca Labs. | Producer | India | India | CEP, CoA, FDA, KDMF, USDMF, WC | 2 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Strides Pharma Science | Producer | India | Unknown | CEP, CoA, GMP | 14 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
When sending a request, specify which Ranitidine 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 Ranitidine 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.
