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Amlodipine | CAS No: 88150-42-9 | GMP-certified suppliers
A medication that helps manage hypertension and coronary artery–related angina, supporting reliable blood pressure control and symptom relief across key cardiovascular indications for global therapeutic use.
Therapeutic categories
Primary indications
- Amlodipine may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of the following conditions [FDA label]:
- Hypertension
- Coronary artery disease
- Chronic stable angina
Product Snapshot
- Amlodipine is an oral small‑molecule API supplied mainly in tablet and capsule formulations
- It is used for hypertension and for chronic, stable, or vasospastic angina associated with coronary artery disease
- It is approved in the US, EU, and Canada
Clinical Overview
Amlodipine produces peripheral arterial vasodilation through inhibition of calcium ion influx into vascular smooth muscle. Its selectivity for vascular tissue relative to cardiac muscle contributes to blood pressure reduction with limited effects on myocardial contractility or conduction. The compound binds to both dihydropyridine and nondihydropyridine sites on cell membranes, supporting its prolonged duration of action and suitability for once‑daily dosing.
Pharmacodynamically, amlodipine reduces peripheral vascular resistance without producing clinically significant changes in heart rate or plasma catecholamine levels during chronic administration. In angina, symptom relief is attributed to decreased afterload and coronary artery dilation, improving oxygen delivery in both stable ischemic disease and vasospastic conditions.
Amlodipine displays strong membrane affinity, which contributes to sustained calcium channel blockade. It is a substrate of CYP3A pathways and demonstrates inhibitory interactions across several cytochrome P450 isoforms, although the clinical relevance varies. The drug is also reported as both a substrate and inhibitor of P‑glycoprotein. Detailed ADME parameters vary by source, but the clinical profile reflects gradual absorption, extensive tissue distribution, and hepatic metabolism.
Safety considerations include dose‑related peripheral edema, dizziness, and flushing, consistent with vasodilatory effects. Amlodipine does not significantly alter sinoatrial or atrioventricular nodal conduction and is generally not associated with bradyarrhythmias.
Common global brands include Norvasc and various fixed‑dose antihypertensive combinations.
For API procurement, sourcing teams should verify compliance with regional pharmacopoeial monographs, confirm control of dihydropyridine‑related impurities, and ensure robust stability data due to sensitivity of this class to oxidation and light.
Identification & chemistry
| Generic name | Amlodipine |
|---|---|
| Molecule type | Small molecule |
| CAS | 88150-42-9 |
| UNII | 1J444QC288 |
| DrugBank ID | DB00381 |
Pharmacology
| Summary | Amlodipine is a dihydropyridine calcium‑channel blocker that reduces calcium influx through L‑type channels in vascular smooth muscle, producing arterial vasodilation and lowering peripheral resistance. Its primary pharmacodynamic effect is sustained reduction of vascular tone with minimal direct impact on cardiac conduction. In coronary disease and angina, the drug decreases myocardial oxygen demand by lowering afterload and can enhance coronary blood flow through dilation of large coronary arteries and arterioles. |
|---|---|
| Mechanism of action | **Mechanism of action on blood pressure** Amlodipine is considered a peripheral arterial vasodilator that exerts its action directly on vascular smooth muscle to lead to a reduction in peripheral vascular resistance, causing a decrease in blood pressure. Amlodipine is a dihydropyridine calcium antagonist (calcium ion antagonist or slow-channel blocker) that inhibits the influx of calcium ions into both vascular smooth muscle and cardiac muscle. Experimental studies imply that amlodipine binds to both _dihydropyridine_ and _nondihydropyridine_ binding sites, located on cell membranes. The contraction of cardiac muscle and vascular smooth muscle are dependent on the movement of extracellular calcium ions into these cells by specific ion channels. Amlodipine blocks calcium ion influx across cell membranes with selectivity. A stronger effect of amlodipine is exerted on vascular smooth muscle cells than on cardiac muscle cells [FDA label]. Direct actions of amlodipine on vascular smooth muscle result in reduced blood pressure . **Mechanism of action in angina** The exact mechanism by which amlodipine relieves the symptoms of angina have not been fully elucidated to this date, however, the mechanism of action is likely twofold: Amlodipine has a dilating effect on peripheral arterioles, reducing the total peripheral resistance (afterload) against which the cardiac muscle functions. Since the heart rate remains stable during amlodipine administration, the reduced work of the heart reduces both myocardial energy use and oxygen requirements . Dilatation of the main coronary arteries and coronary arterioles, both in healthy and ischemic areas, is another possible mechanism of amlodipine reduction of blood pressure. The dilatation causes an increase in myocardial oxygen delivery in patients experiencing coronary artery spasm (Prinzmetal's or variant angina) and reduces coronary vasoconstriction caused by smoking . |
| Pharmacodynamics | **General pharmacodynamic effects** Amlodipine has a strong affinity for cell membranes, modulating calcium influx by inhibiting selected membrane calcium channels. This drug's unique binding properties allow for its long-acting action and less frequent dosing regimen , [FDA label]. **Hemodynamic effects** After the administration of therapeutic doses of amlodipine to patients diagnosed with hypertension, amlodipine causes vasodilation, which results in a reduction of supine and standing blood pressure. During these blood pressure reductions, there are no clinically significant changes in heart rate or plasma catecholamine levels with long-term use. Acute intravenous administration of amlodipine reduces arterial blood pressure and increases heart rate in patients with chronic stable angina, however, chronic oral administration of amlodipine in clinical studies did not cause clinically significant alterations in heart rate or blood pressures in patients diagnosed with angina and normal blood pressure. With long-term, once daily oral administration, antihypertensive effectiveness is maintained for at least 24 hours [FDA label]. **Electrophysiologic effects** Amlodipine does not change sinoatrial (SA) nodal function or atrioventricular (AV) conduction in animals or humans. In patients who were diagnosed with chronic stable angina, the intravenous administration of 10 mg of amlodipine did not cause clinically significant alterations A-H and H-V conduction and sinus node recovery time after cardiac pacing. Patients administered amlodipine with concomitant beta-blockers produced similar results. In clinical trials in which amlodipine was given in combination with beta-blockers to patients diagnosed with hypertension or angina, no adverse effects on electrocardiographic parameters were noted. In clinical studies comprised of angina patients alone, amlodipine did not change electrocardiographic intervals or produce high degrees of AV block [FDA label]. **Effects on angina** Amlodipine relieves the symptoms of chest pain associated with angina. In patients diagnosed with angina, daily administration of a single amlodipine dose increases total exercise time, the time to angina onset, and the time to 1 mm ST-segment depression on ECG studies, decreases anginal attack frequency, and decreases the requirement for nitroglycerin tablets . |
Targets
| Target | Organism | Actions |
|---|---|---|
| Voltage-dependent L-type calcium channel subunit alpha-1C | Humans | inhibitor |
| Voltage-dependent T-type calcium channel subunit alpha-1I | Humans | inhibitor |
| Voltage-dependent N-type calcium channel subunit alpha-1B | Humans | inhibitor |
ADME / PK
| Absorption | Amlodipine absorbed slowly and almost completely from the gastrointestinal tract. Peak plasma concentrations are achieved 6-12 hours after oral administration. The estimated bioavailability of amlodipine is 64-90%. Steady-state plasma amlodipine levels are achieved after 7-8 days of consecutive daily dosing. Absorption is not affected by food [FDA label]. |
|---|---|
| Half-life | The terminal elimination half-life of about 30–50 hours [FDA label]. Plasma elimination half-life is 56 hours in patients with impaired hepatic function, titrate slowly when administering this drug to patients with severe hepatic impairment [FDA label]. |
| Protein binding | About 98% , . |
| Metabolism | Amlodipine is heavily (approximately 90%) converted to inactive metabolites via hepatic breakdown with 10% of the parent compound and 60% of the metabolites found excreted in the urine. _Ex vivo_ studies have shown that about 93% of the circulating drug is bound to plasma proteins in hypertensive patients [FDA label]. Characteristics that add to amlodipine's unique pharmacologic profile include nearly complete absorption, late-peak plasma concentrations, high bioavailability, and slow hepatic breakdown . |
| Route of elimination | Elimination from the plasma occurs in a biphasic with a terminal elimination half-life of about 30–50 hours. Steady-state plasma levels of amlodipine are reached after 7-8 days of consecutive daily dosing [FDA label]. Amlodipine is 10% excreted as unchanged drug in the urine. Amlodipine can be initiated at normal doses in patients diagnosed with renal failure , [FDA label]. |
| Volume of distribution | 21 L/kg , . |
| Clearance | Total body clearance (CL) has been calculated as 7 ± 1.3 ml/min/kg (0.42 ± 0.078 L/ h/kg) in healthy volunteers , . Elderly patients show a reduced clearance of amlodipine with an AUC (area under the curve) increase of about 40–60%, and a lower initial dose may be required [FDA label]. |
Formulation & handling
- Amlodipine is an oral small‑molecule API with very low aqueous solubility, favoring use of solid oral tablets, capsules, and solution/suspension systems requiring solubilizers.
- Its moderate LogP and poor water solubility may require dissolution‑enhancing strategies (e.g., salts, wet granulation, or liquid‑filled capsules) for consistent oral absorption.
- Food does not affect absorption, but grapefruit products should be avoided, so formulation does not need food‑dependent release design.
Regulatory status
| Lifecycle | Most patent protection for the API in Canada and the United States expired between 2014 and 2019, indicating that exclusivity has lapsed across major markets. With availability reported in Canada, the US, and the EU, the product is in a mature, post‑patent phase. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Amlodipine’s originator is Pfizer, but the market is now dominated by numerous generic manufacturers, reflecting a well‑established and highly competitive supply base. Branded and generic products have broad global availability across the US, EU, and Canada. Patent expiries between 2014 and 2019 indicate that exclusivity has lapsed, supporting the wide presence of mature generic competition. |
|---|
Safety
| Toxicity | **Acute oral toxicity (LD50)**: 37 mg/kg (mouse) [MSDS]. **Overdose** An overdose of amlodipine could result in a high degree of peripheral vasodilatation with a possibility of reflex tachycardia. Significant and prolonged hypotension leading to shock and fatal outcomes have been reported [FDA label]. **Carcinogenesis, mutagenesis, impairment of fertility** Rats and mice treated with amlodipine maleate in the diet on a long-term basis for up to 2 years demonstrated no evidence of a carcinogenic effect of the drug. For the mouse, the highest dose was comparable to the maximum recommended human dose of 10 mg amlodipine per day. For the rat, the highest dose was measured to be about twice the maximum recommended human dose [FDA label]. Mutagenicity studies using amlodipine maleate showed no drug-related gene or chromosomal effects [FDA label]. There was no impact on the fertility of rats given oral amlodipine maleate (males for 64 days and females for 14 days before mating) at doses up to 10 mg amlodipine/kg/day (8 times the maximum recommended human dose) [FDA label]. **Use in pregnancy** The safety of amlodipine in human pregnancy or lactation has not been proven. Amlodipine is therefore considered a pregnancy category C drug . Use amlodipine only if the potential benefit justifies the potential risk [FDA label]. **Use in nursing** Discontinue when administering amlodipine [FDA label]. |
|---|
- Acute oral toxicity is high, with an LD50 of 37 mg/kg in mice, indicating significant hazard on ingestion at relatively low doses
- Overexposure can induce marked peripheral vasodilation, reflex tachycardia, and prolonged hypotension with potential progression to shock and fatal outcomes
- Long‑term studies show no carcinogenic or mutagenic activity in rodents, and no fertility impairment at exposures several‑fold above human‑equivalent doses
Amlodipine is a type of Calcium Channel Blockers
Calcium channel blockers (CCBs) are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the treatment of various cardiovascular conditions. CCBs work by blocking the influx of calcium ions into smooth muscle cells and cardiac muscle cells, leading to vasodilation and reduced cardiac contractility.
CCBs are commonly prescribed to manage hypertension (high blood pressure), angina (chest pain), and certain arrhythmias (irregular heart rhythms). They are also effective in treating Raynaud's disease and migraine headaches. These medications exert their therapeutic effects by selectively inhibiting L-type calcium channels in the heart and blood vessels.
By blocking calcium channels, CCBs help relax and widen blood vessels, reducing peripheral resistance and improving blood flow. This mechanism of action lowers blood pressure, relieves angina symptoms, and helps prevent certain types of abnormal heart rhythms.
Some well-known CCBs include amlodipine, nifedipine, diltiazem, and verapamil. These medications are available in various formulations, including immediate-release and extended-release tablets, as well as injectable solutions.
It's important to note that CCBs may cause certain side effects, such as dizziness, headache, flushing, and ankle swelling. They may also interact with other medications, so it's crucial to consult a healthcare professional before starting or changing any CCB therapy.
In summary, Calcium channel blockers are a subcategory of cardiovascular medications that inhibit calcium channels, resulting in vasodilation, decreased cardiac contractility, and overall therapeutic effects in conditions such as hypertension, angina, and arrhythmias. Proper medical supervision and individualized treatment plans are essential for optimizing the use of CCBs.
Amlodipine (Calcium Channel Blockers), classified under Antihypertensive agents
Antihypertensive agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat high blood pressure, also known as hypertension. These medications are designed to lower blood pressure and reduce the risk of associated cardiovascular complications.
Antihypertensive agents function by targeting various mechanisms involved in blood pressure regulation. Some common classes of antihypertensive agents include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, calcium channel blockers (CCBs), and diuretics.
ACE inhibitors work by inhibiting the enzyme responsible for converting angiotensin I to angiotensin II, a hormone that constricts blood vessels. ARBs, on the other hand, block the receptors to which angiotensin II binds, thereby preventing its vasoconstrictive effects.
Beta-blockers reduce blood pressure by blocking the effects of adrenaline and noradrenaline, which are responsible for increasing heart rate and constricting blood vessels. CCBs inhibit calcium from entering the smooth muscles of blood vessels, resulting in relaxation and vasodilation. Diuretics promote the elimination of excess fluid and sodium from the body, reducing blood volume and thereby lowering blood pressure.
Antihypertensive agents are typically prescribed based on the individual patient's condition and specific needs. They can be used alone or in combination to achieve optimal blood pressure control. It is important to note that antihypertensive agents should be taken regularly as prescribed by a healthcare professional and may require periodic monitoring to ensure their effectiveness and manage any potential side effects.
In summary, antihypertensive agents play a vital role in the management of hypertension by targeting various mechanisms involved in blood pressure regulation. These medications offer significant benefits in reducing the risk of cardiovascular complications associated with high blood pressure.
Amlodipine API manufacturers & distributors
Compare qualified Amlodipine API suppliers worldwide. We currently have 26 companies offering Amlodipine API, with manufacturing taking place in 6 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 |
| Amsal Chem | Producer | India | India | CoA, ISO9001, USDMF, WC, WHO-GMP | 8 products |
| Arch Pharmalabs | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 19 products |
| ARLIVI Healthcare | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, ISO14001, ISO9001, JDMF, KDMF, WHO-GMP | 21 products |
| Cipla | Producer | India | Unknown | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 164 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, JDMF, KDMF, MSDS, USDMF, WC | 170 products |
| Gedeon Richter | Producer | Hungary | Unknown | CEP, CoA, FDA, GMP | 48 products |
| Glochem | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF, WC | 14 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hari Ganesh Pharma Privat... | Distributor | India | India | CoA, FDA, GMP, USDMF | 35 products |
| Hetero Drugs | Producer | India | Unknown | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF, WC | 98 products |
| Ipca Labs. | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 69 products |
| KRKA | Producer | Slovenia | Unknown | CEP, CoA, GMP | 81 products |
| Lek Pharma | Producer | Slovenia | Unknown | CEP, CoA, GMP, JDMF, KDMF, USDMF | 32 products |
| Lupin | Producer | India | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 155 products |
| Malladi Drugs & Pharma | Producer | India | India | CoA, GMP, WC | 14 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, JDMF, KDMF, Other, USDMF | 50 products |
| Mylan | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 201 products |
| Sanofi | Producer | France | Unknown | CEP, CoA, GMP | 93 products |
| Shandong Xinhua | Producer | China | China | CoA, USDMF | 21 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS, USDMF | 764 products |
| Srini Pharma | Producer | India | India | CoA, USDMF | 12 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| Unichem Labs. | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 62 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 144 products |
| Zentiva S.Ü.S.V.T. | Producer | Turkey | Turkey | CEP, CoA, GMP | 1 products |
When sending a request, specify which Amlodipine 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 Amlodipine 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.
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