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Nifedipine | CAS No: 21829-25-4 | GMP-certified suppliers
A medication that helps manage vasospastic and chronic stable angina as well as hypertension by supporting reliable cardiovascular symptom control for diverse therapeutic needs.
Therapeutic categories
Primary indications
- Nifedipine capsules are indicated to treat vasospastic angina and chronic stable angina
- Extended release tablets are indicated to treat vasospastic angina, chronic stable angina, and hypertension
Product Snapshot
- Nifedipine is an oral small‑molecule calcium channel blocker available in multiple immediate‑ and extended‑release solid-dosage formulations
- It is used in B2B supply chains for products targeting vasospastic angina, chronic stable angina, and hypertension
- It is approved in the US and Canada
Clinical Overview
Nifedipine acts by inhibiting L‑type voltage‑gated calcium channels in vascular smooth muscle and myocardial tissue. The blockade of calcium influx during cellular depolarization reduces arterial smooth muscle tone, leading to peripheral vasodilation, decreased afterload, and enhanced coronary artery dilation. These effects collectively support improved myocardial oxygen supply and reduction of anginal symptoms.
Pharmacodynamic activity is characterized by dose‑dependent blood pressure reduction and vasodilation. Immediate‑release formulations exhibit a short duration of action requiring dosing up to three times daily, while typical total daily dosing ranges from 10 to 120 mg depending on formulation and clinical context.
Key safety considerations include the risk of excessive hypotension, reflex tachycardia, worsening angina, and myocardial infarction, particularly with rapid‑onset formulations. Clinicians monitor for hemodynamic instability and adjust dosing carefully in patients with compromised cardiac function. Nifedipine is listed across multiple drug categories, including antihypertensive agents, dihydropyridine calcium channel blockers, vasodilating agents, and various cytochrome P‑450 substrate and inhibitor classifications. These designations reflect important interaction potential, particularly with agents affecting metabolic or transport pathways.
Although detailed absorption, distribution, metabolism, and excretion parameters are not provided here, nifedipine’s classification as a substrate and inhibitor of several CYP450 and transporter systems supports the need for careful assessment of co‑medications during clinical use.
For API procurement, sourcing teams should verify compliance with regional pharmacopeial standards, control for photostability due to the compound’s light sensitivity, and ensure consistent polymorphic and impurity profiles to support robust formulation and regulatory submissions.
Identification & chemistry
| Generic name | Nifedipine |
|---|---|
| Molecule type | Small molecule |
| CAS | 21829-25-4 |
| UNII | I9ZF7L6G2L |
| DrugBank ID | DB01115 |
Pharmacology
| Summary | Nifedipine inhibits L‑type voltage‑gated calcium channels in vascular smooth muscle and myocardium, limiting calcium influx during depolarization. This decreases peripheral vascular resistance and dilates coronary arteries, supporting its use in conditions driven by increased afterload or impaired coronary blood flow. Its pharmacodynamic profile centers on arterial vasodilation and reduced myocardial oxygen demand. |
|---|---|
| Mechanism of action | Nifedipine blocks voltage gated L-type calcium channels in vascular smooth muscle and myocardial cells.This blockage prevents the entry of calcium ions into cells during depolarization, reducing peripheral arterial vascular resistance and dilating coronary arteries.These actions reduce blood pressure and increase the supply of oxygen to the heart, alleviating angina. |
| Pharmacodynamics | Nifedipine is an inhibitor of L-type voltage gated calcium channels that reduces blood pressure and increases oxygen supply to the heart.Immediate release nifedipine's duration of action requires dosing 3 times daily.Nifedipine dosing is generally 10-120mg daily.Patients should be counselled regarding the risk of excessive hypotension, angina, and myocardial infarction. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Voltage-dependent L-type calcium channel subunit alpha-1C | Humans | inhibitor |
| Voltage-dependent L-type calcium channel subunit alpha-1D | Humans | inhibitor |
| Voltage-dependent L-type calcium channel subunit beta-2 | Humans | inhibitor |
ADME / PK
| Absorption | Sublingual dosing leads to a C<sub>max</sub> of 10ng/mL, with a T<sub>max</sub> of 50min, and an AUC of 25ng\*h/mL.Oral dosing leads to a C<sub>max</sub> of 82ng/mL, with a T<sub>max</sub> of 28min, and an AUC of 152ng\*h/mL. Nifedipine is a Biopharmaceutics Classification System Class II drug, meaning it has low solubility and high intestinal permeability.It is almost completely absorbed in the gastrointestinal tract but has a bioavilability of 45-68%, partly due to first pass metabolism. |
|---|---|
| Half-life | The terminal elimination half life of nifedipine is approximately 2 hours. |
| Protein binding | Nifedipine is 92-98% protein bound in serum.Nifedipine is 97±12% bound in a 40g/L solution of pure albumin.Nifedipine is 51.4±5.9% protein bound in a 50mg/100mL solution of alpha-1-acid glycoprotein, and 75.5±3.5% protein bound in a 150mg/mL solution. |
| Metabolism | Nifedipine is predominantly metabolized by CYP3A4.Nifedipine is predominantly metabolized to 2,6-dimethyl-4-(2-nitrophenyl)-5-methoxycarbonyl-pyridine-3-carboxylic acid, and then further metabolized to 2-hydroxymethyl-pyridine carboxylic acid.Nifedipine is also minorly metabolized to dehydronifedipine. |
| Route of elimination | Nifedipine is 60-80% recovered in the urine as inactive water soluble metabolites, and the rest is eliminated in the feces as metabolites. |
| Volume of distribution | The steady state volume of distribution of nifedipine is 0.62-0.77L/kg and the volume of distribution of the central compartment is 0.25-0.29L/kg. |
| Clearance | The total body clearance of nifedipine is 450-700mL/min. |
Formulation & handling
- Low aqueous solubility and moderate lipophilicity support use of solubilizing excipients or liquid‑filled capsules for immediate‑release oral formulations, while controlled‑release matrices are commonly used to manage rapid absorption.
- Light- and oxidation‑sensitive small molecule; requires protection from light and careful control of processing conditions to prevent degradation.
- CYP3A4‑mediated metabolism and known grapefruit interaction are relevant for excipient and packaging selection but do not impose food‑dependent administration requirements.
Regulatory status
| Lifecycle | The active ingredient’s U.S. patent expired in 2010, indicating that it is well into a mature generic phase. With availability in the United States and Canada, the product now occupies a stable, established market position typical of post‑expiry pharmaceuticals. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Nifedipine originated from a single innovator but is now supplied by a wide field of packagers and generic manufacturers, reflecting a mature and highly distributed supply base. Branded products such as Adalat have long-standing presence in the US, Canada, and other global markets. Patent expiry in 2010 removed exclusivity, and the extensive list of packagers indicates well‑established generic competition. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> in rats is 1022mg/kg and in mice is 202mg/kg. Patients experiencing an overdose may present with hypotension, sinus node dysfunction, atrioventricular node dysfunction, and reflex tachycardia.Overdose may be managed by monitoring cardiovascular and respiratory function; elevating extremities; and administering vasopressors, fluids, and calcium infusions. |
|---|
- Acute oral toxicity is moderate to high, with LD50 values of about 1022 mg/kg in rats and 202 mg/kg in mice, indicating greater sensitivity in murine models
- Overexposure is associated with cardiovascular depression, including hypotension and conduction disturbances such as sinus and atrioventricular node dysfunction
- Reflex tachycardia may occur secondary to vasodilation, highlighting the need for controls that limit excessive systemic exposure during handling and processing
Certificate of Suitability
CEP (also known as COS) is a certificate that proves that qualifies to the relevant monograph of the European Pharmacopoeia. It links the monograph in the Ph.Eur. to the API itself. A CEP is submitted by the manufacturer as part of the market authorization process, and they will become the CEP holder of the document. Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes such as the FDA in the US. Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
Nifedipine 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.
Nifedipine (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.
Nifedipine API manufacturers & distributors
Compare qualified Nifedipine API suppliers worldwide. We currently have 17 companies offering Nifedipine API, with manufacturing taking place in 11 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 |
| Bayer | Producer | Germany | Unknown | CEP, CoA, GMP, KDMF, USDMF | 42 products |
| Chifeng Arker Tech. | Producer | China | China | CoA, WC | 8 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Switzerland | BSE/TSE, CoA, GMP, ISO9001, MSDS | 170 products |
| Evonik TC | Producer | Germany | Germany | CEP, CoA, FDA, GMP | 7 products |
| Hänseler AG | Distributor | Switzerland | Switzerland | CoA, GMP, MSDS | 174 products |
| Ipca Labs. | Producer | India | India | CEP, CoA, FDA, GMP, WC | 69 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Mikuni Pharmaceutical Ind... | Producer | Japan | Japan | CoA, JDMF | 1 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, JDMF, USDMF | 50 products |
| Sharon Bio-Medicine | Producer | India | India | CoA, USDMF | 12 products |
| Shilpa Medicare Ltd | Producer | India | India | BSE/TSE, CoA, GMP, ISO9001, MSDS, WC | 54 products |
| Sicor | Producer | Italy | Italy | CoA, GMP | 47 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Unique Chemicals | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 8 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 140 products |
When sending a request, specify which Nifedipine 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 Nifedipine 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 Nifedipine API
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Technical
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