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Captopril | CAS No: 62571-86-2 | GMP-certified suppliers
A medication that treats essential and renovascular hypertension, supports management of congestive heart failure, improves post‑infarction outcomes, and slows progression of nephropathy including diabetic forms.
Therapeutic categories
Primary indications
- For the treatment of essential or renovascular hypertension (usually administered with other drugs, particularly thiazide diuretics)
- May be used to treat congestive heart failure in combination with other drugs (e
- G
- Cardiac glycosides, diuretics, &beta
Product Snapshot
- Oral small‑molecule API available mainly as tablets and solutions for finished‑dose development
- Primary uses include management of hypertension, heart failure, post‑myocardial‑infarction ventricular dysfunction, and nephropathy such as diabetic nephropathy
- Approved in the US and Canada with established regulatory acceptance in both markets
Clinical Overview
Captopril competitively inhibits ACE, blocking the conversion of angiotensin I to angiotensin II and attenuating downstream effects of the renin‑angiotensin‑aldosterone system. Reduced angiotensin II levels limit aldosterone‑mediated sodium and water retention, diminish vasopressin release, and relieve direct vasoconstriction of vascular smooth muscle. Increased bradykinin secondary to kininase II inhibition contributes additional vasodilatory activity. These changes lower systemic vascular resistance and blood pressure.
Captopril is one of the few ACE inhibitors administered in its active form, eliminating the need for metabolic activation. It exhibits rapid oral absorption with a relatively short half‑life, leading to multiple daily dosing in routine clinical practice. Renal elimination is the predominant route. Reduced feedback inhibition from angiotensin II increases plasma renin activity during treatment, consistent with pharmacological expectations for RAAS blockade.
Adverse effects include cough, dizziness, hypotension, hyperkalemia, renal function changes, and a known risk of angioedema. Bradykinin accumulation contributes to several of these events. Captopril is also associated with rare but serious hematologic toxicity, particularly in susceptible populations. Concomitant use with potassium‑sparing agents or renal impairment heightens the likelihood of hyperkalemia.
Widely recognized brands include Capoten and region‑specific generics. Formulators and regulatory teams should ensure API lots meet compendial purity requirements, control for sulfhydryl‑related impurities, and confirm stability under standard storage conditions. Reliable sourcing should include full documentation of manufacturing process controls and evidence of consistency across batches for regulatory submissions.
Identification & chemistry
| Generic name | Captopril |
|---|---|
| Molecule type | Small molecule |
| CAS | 62571-86-2 |
| UNII | 9G64RSX1XD |
| DrugBank ID | DB01197 |
Pharmacology
| Summary | Captopril is an angiotensin‑converting enzyme inhibitor that blocks both the N‑ and C‑domains of ACE, with predominant functional impact on the C‑domain responsible for angiotensin II generation. By inhibiting ACE, it reduces formation of angiotensin II and limits downstream RAAS signaling, including vasoconstrictive and volume‑retentive pathways. The drug also increases bradykinin levels by preventing its degradation, contributing to its overall hemodynamic effects. |
|---|---|
| Mechanism of action | There are two isoforms of ACE: the somatic isoform, which exists as a glycoprotein comprised of a single polypeptide chain of 1277; and the testicular isoform, which has a lower molecular mass and is thought to play a role in sperm maturation and binding of sperm to the oviduct epithelium. Somatic ACE has two functionally active domains, N and C, which arise from tandem gene duplication. Although the two domains have high sequence similarity, they play distinct physiological roles. The C-domain is predominantly involved in blood pressure regulation while the N-domain plays a role in hematopoietic stem cell differentiation and proliferation. ACE inhibitors bind to and inhibit the activity of both domains, but have much greater affinity for and inhibitory activity against the C-domain. Captopril, one of the few ACE inhibitors that is not a prodrug, competes with ATI for binding to ACE and inhibits and enzymatic proteolysis of ATI to ATII. Decreasing ATII levels in the body decreases blood pressure by inhibiting the pressor effects of ATII as described in the Pharmacology section above. Captopril also causes an increase in plasma renin activity likely due to a loss of feedback inhibition mediated by ATII on the release of renin and/or stimulation of reflex mechanisms via baroreceptors. Captopril’s affinity for ACE is approximately 30,000 times greater than that of ATI. |
| Pharmacodynamics | Captopril, an ACE inhibitor, antagonizes the effect of the RAAS. The RAAS is a homeostatic mechanism for regulating hemodynamics, water and electrolyte balance. During sympathetic stimulation or when renal blood pressure or blood flow is reduced, renin is released from the granular cells of the juxtaglomerular apparatus in the kidneys. In the blood stream, renin cleaves circulating angiotensinogen to ATI, which is subsequently cleaved to ATII by ACE. ATII increases blood pressure using a number of mechanisms. First, it stimulates the secretion of aldosterone from the adrenal cortex. Aldosterone travels to the distal convoluted tubule (DCT) and collecting tubule of nephrons where it increases sodium and water reabsorption by increasing the number of sodium channels and sodium-potassium ATPases on cell membranes. Second, ATII stimulates the secretion of vasopressin (also known as antidiuretic hormone or ADH) from the posterior pituitary gland. ADH stimulates further water reabsorption from the kidneys via insertion of aquaporin-2 channels on the apical surface of cells of the DCT and collecting tubules. Third, ATII increases blood pressure through direct arterial vasoconstriction. Stimulation of the Type 1 ATII receptor on vascular smooth muscle cells leads to a cascade of events resulting in myocyte contraction and vasoconstriction. In addition to these major effects, ATII induces the thirst response via stimulation of hypothalamic neurons. ACE inhibitors inhibit the rapid conversion of ATI to ATII and antagonize RAAS-induced increases in blood pressure. ACE (also known as kininase II) is also involved in the enzymatic deactivation of bradykinin, a vasodilator. Inhibiting the deactivation of bradykinin increases bradykinin levels and may sustain its effects by causing increased vasodilation and decreased blood pressure. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Angiotensin-converting enzyme | Humans | inhibitor |
| 72 kDa type IV collagenase | Humans | inhibitor |
| Matrix metalloproteinase-9 | Humans | inhibitor |
ADME / PK
| Absorption | 60-75% in fasting individuals; food decreases absorption by 25-40% (some evidence indicates that this is not clinically significant) |
|---|---|
| Half-life | 2 hours |
| Protein binding | 25-30% bound to plasma proteins, primarily albumin |
| Metabolism | Hepatic. Major metabolites are captopril-cysteine disulfide and the disulfide dimer of captopril. Metabolites may undergo reversible interconversion. |
Formulation & handling
- Oral small‑molecule ACE inhibitor suitable for tablets and solutions; exhibits good aqueous solubility supporting conventional solid‑dose processing.
- Absorption is reduced by food, so formulations generally target administration on an empty stomach rather than modified‑release matrices dependent on fed‑state conditions.
- Contains a free thiol group that can undergo oxidation; handling and packaging should limit oxidative exposure and moisture to maintain stability.
Regulatory status
| Lifecycle | The active ingredient’s primary U.S. patent expired in 2010, indicating that the product is in a mature post‑exclusivity phase. With availability in the United States and Canada, the market is expected to be fully genericized and stable. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Captopril’s originator development traces back to a single innovator company, but the current supply landscape is dominated by numerous manufacturers and repackagers, reflecting its long-established generic status. Branded and generic products are widely available in the US and Canada, with no indications of active exclusivities limiting distribution. The listed patent expired in 2010, consistent with the mature generic competition seen across the market. |
|---|
Safety
| Toxicity | Symptoms of overdose include emesis and decreased blood pressure. Side effects include dose-dependent rash (usually maculopapular), taste alterations, hypotension, gastric irritation, cough, and angioedema. |
|---|
- Overexposure may lead to emesis and hypotension
- Monitor for angioedema risk and dose‑dependent dermatologic reactions during handling or evaluation
- Compound is associated with gastric and upper‑airway irritation, including cough and taste disturbances
Captopril is a type of ACE inhibitors
ACE inhibitors, or angiotensin-converting enzyme inhibitors, are a subcategory of pharmaceutical APIs (active pharmaceutical ingredients) commonly used in the treatment of various cardiovascular conditions. These medications work by inhibiting the activity of the angiotensin-converting enzyme, which plays a crucial role in the regulation of blood pressure and fluid balance.
By blocking the action of this enzyme, ACE inhibitors help relax and widen the blood vessels, reducing peripheral resistance and ultimately lowering blood pressure. This mechanism of action makes ACE inhibitors highly effective in treating hypertension (high blood pressure) and congestive heart failure.
Additionally, ACE inhibitors have been found to be beneficial for patients with certain kidney disorders and diabetic nephropathy. By dilating the renal blood vessels, they can help improve renal function and reduce proteinuria.
Some commonly prescribed ACE inhibitors include lisinopril, enalapril, and ramipril. These medications are typically administered orally and are available in various dosage forms, including tablets and capsules.
It's worth noting that ACE inhibitors may have certain side effects, such as dry cough, dizziness, and hyperkalemia (high potassium levels). However, these side effects are generally mild and well-tolerated by most patients.
In summary, ACE inhibitors are a vital subcategory of pharmaceutical APIs used in the management of hypertension, heart failure, and certain renal disorders. Their ability to lower blood pressure and improve renal function makes them an essential tool in the treatment of cardiovascular diseases.
Captopril (ACE inhibitors), 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.
Captopril API manufacturers & distributors
Compare qualified Captopril API suppliers worldwide. We currently have 12 companies offering Captopril 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 |
| Azelis | Producer | Germany | Germany | CEP, CoA, GMP | 4 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Changzhou Pharmaceutical ... | Producer | China | China | CoA, WC | 3 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, USDMF | 252 products |
| Duchefa Farma B.V. | Distributor | Netherlands | China | CoA, GMP, ISO9001, MSDS | 170 products |
| Lusochimica | Producer | Italy | Italy | CoA, GMP | 23 products |
| Medichem | Producer | Spain | Unknown | CoA, USDMF | 39 products |
| Quimica Sintetica | Producer | Spain | Unknown | CoA, GMP, USDMF | 51 products |
| Shandong Weifang Pharmace... | Producer | China | China | CoA, JDMF, WC | 1 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, USDMF | 764 products |
| Zhongfu Pharma | Producer | China | China | CEP, CoA, USDMF, WC | 1 products |
When sending a request, specify which Captopril 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 Captopril 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 Captopril API
Sourcing
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Technical
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Regulatory
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Pharmaoffer
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