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Ramipril | CAS No: 87333-19-5 | GMP-certified suppliers
A medication that manages hypertension, lowers the risk of major cardiovascular events, supports post‑infarction patients with heart failure signs, and helps slow renal disease progression in high‑risk individuals.
Therapeutic categories
ACE Inhibitors and Calcium Channel BlockersACE Inhibitors and DiureticsAgents Acting on the Renin-Angiotensin SystemAgents causing angioedemaAgents causing hyperkalemiaAngiotensin-Converting Enzyme Inhibitors
Generic name
Ramipril
Molecule type
small molecule
CAS number
87333-19-5
DrugBank ID
DB00178
Approval status
Approved drug
ATC code
C09BX03
Primary indications
- For the management of mild to severe hypertension
- May be used to reduce cardiovascular mortality following myocardial infarction in hemodynamically stable individuals who develop clinical signs of congestive heart failure within a few days following myocardial infarction
- [FDA Label] To reduce the rate of death, myocardial infarction and stroke in individuals at high risk of cardiovascular events
- May be used to slow the progression of renal disease in individuals with hypertension, diabetes mellitus and microalubinuria or overt nephropathy
Product Snapshot
- Oral small‑molecule formulation supplied mainly as tablets and capsules
- Used for hypertension management and broader cardiovascular risk reduction, including post‑MI mortality reduction and renal protection in hypertensive diabetic populations
- Approved in major regulated markets including the US and Canada
Clinical Overview
Ramipril (CAS 87333-19-5) is an angiotensin‑converting enzyme inhibitor used for the management of mild to severe hypertension and to reduce cardiovascular mortality following myocardial infarction in hemodynamically stable patients with signs of congestive heart failure. It is also used to lower the risk of cardiovascular events in high‑risk individuals and to slow renal disease progression in patients with hypertension, diabetes, and microalbuminuria or overt nephropathy.
Ramipril is an inactive dipeptide prodrug that is converted primarily in the liver to its active metabolite, ramiprilat. Ramiprilat produces antihypertensive effects by inhibiting ACE, blocking the conversion of angiotensin I to angiotensin II. Reduced angiotensin II levels diminish activation of AT1 receptors, lowering aldosterone release, vasopressin secretion, and direct vascular smooth muscle constriction. This leads to decreased systemic vascular resistance and improved hemodynamics. Decreased AT1 receptor signaling also reduces pathways associated with inflammation, oxidative stress, and fibrosis. Lesser activation of AT2 receptors contributes to vasodilation and nitric oxide–mediated effects. Inhibition of bradykinin breakdown further enhances vasodilation but is associated with the well‑recognized ACE inhibitor dry cough.
Ramipril is absorbed orally and undergoes hepatic ester hydrolysis to ramiprilat, which has a longer half‑life and accounts for sustained ACE inhibition. Renal elimination is the primary route of excretion. Exposure may increase in renal impairment.
Safety considerations include risks of hypotension, hyperkalemia, renal function decline in susceptible populations, and angioedema. Use is contraindicated during pregnancy due to fetal toxicity. Cough is a common adverse effect related to bradykinin accumulation.
Ramipril is marketed globally in multiple strengths, with Altace being a widely recognized brand reference. Formulation strategies typically aim to ensure stable prodrug integrity and predictable conversion to ramiprilat.
For API procurement, suppliers should provide evidence of control of stereochemistry, validated impurity profiles, and compliance with major pharmacopeial specifications. Robust documentation of stability and residual solvent control supports regulatory and formulation requirements.
Ramipril is an inactive dipeptide prodrug that is converted primarily in the liver to its active metabolite, ramiprilat. Ramiprilat produces antihypertensive effects by inhibiting ACE, blocking the conversion of angiotensin I to angiotensin II. Reduced angiotensin II levels diminish activation of AT1 receptors, lowering aldosterone release, vasopressin secretion, and direct vascular smooth muscle constriction. This leads to decreased systemic vascular resistance and improved hemodynamics. Decreased AT1 receptor signaling also reduces pathways associated with inflammation, oxidative stress, and fibrosis. Lesser activation of AT2 receptors contributes to vasodilation and nitric oxide–mediated effects. Inhibition of bradykinin breakdown further enhances vasodilation but is associated with the well‑recognized ACE inhibitor dry cough.
Ramipril is absorbed orally and undergoes hepatic ester hydrolysis to ramiprilat, which has a longer half‑life and accounts for sustained ACE inhibition. Renal elimination is the primary route of excretion. Exposure may increase in renal impairment.
Safety considerations include risks of hypotension, hyperkalemia, renal function decline in susceptible populations, and angioedema. Use is contraindicated during pregnancy due to fetal toxicity. Cough is a common adverse effect related to bradykinin accumulation.
Ramipril is marketed globally in multiple strengths, with Altace being a widely recognized brand reference. Formulation strategies typically aim to ensure stable prodrug integrity and predictable conversion to ramiprilat.
For API procurement, suppliers should provide evidence of control of stereochemistry, validated impurity profiles, and compliance with major pharmacopeial specifications. Robust documentation of stability and residual solvent control supports regulatory and formulation requirements.
Identification & chemistry
| Generic name | Ramipril |
|---|---|
| Molecule type | Small molecule |
| CAS | 87333-19-5 |
| UNII | L35JN3I7SJ |
| DrugBank ID | DB00178 |
Pharmacology
| Summary | Ramipril is a prodrug converted to ramiprilat, which inhibits angiotensin‑converting enzyme and suppresses angiotensin II formation, reducing RAAS-mediated vasoconstriction and aldosterone signaling. Lower angiotensin II levels decrease activation of AT1 receptors, limiting pathways linked to vascular tone, inflammation, and oxidative stress, while preserving counter-regulatory AT2 and Mas receptor activity. ACE inhibition also increases bradykinin concentrations, contributing to additional vasodilatory effects. |
|---|---|
| Mechanism of action | Ramipril inhibits the RAAS system by binding to and inhibiting ACE thereby preventing the conversion of angiotensin I to angiotensin II. As plasma levels of angiotensin II fall, less activation of the G-protein coupled receptors angiotensin receptor I (AT<sub>1</sub>R) and angiotensin receptor II (AT<sub>2</sub>R) occurs. AT<sub>1</sub>R mediates vasoconstriction, inflammation, fibrosis, and oxidative stress through a variety of signaling pathways. These include G<sub>q</sub> coupling to the inositol triphosphate pathway, activation of phospholipases C, A<sub>2</sub>, and D which contribute to eicosanoid production, activation of Ca<sup>2+</sup>-dependent and MAP kinases, G<sub>i</sub> and G<sub>12/13</sub>, and eventual activation of the Jak/STAT pathway leading to cell growth and production of extracellular matrix components. AT<sub>1</sub>R activation also leads to increased activity of membrane-bound NADH/NADPH oxidase which contributes to production of reactive oxygen species. Decreased activation of this receptor mediates the renoprotective, antihypertensive, and cardioprotective effects of ramipril by reducing inflammation and vasoconstriction. AT<sub>2</sub>R acts in opposition to the effects of AT<sub>1</sub>R by activating phosphotyrosine phosphatases which inhibit MAP kinases, inhibiting Ca<sup>2+</sup> channel opening, and stimulating cGMP and nitric oxide production leading to vasodilation. These counteracting effects are shared by the Mas receptor which is activated by Ang(1-7), a subtype of angiotensin produced by plasma esterases from AngI or by ACE2 from AngII produced through a secondary pathway by tonin and cathepsin G. Ang(1-7) also activates AT<sub>2</sub>R although the bulk of its effect is mediated by MasR. ACE is also responsible for the breakdown of bradykinin. The resulting buildup of bradykinin due to ACE inhibition is thought to mediate the characteristic dry-cough as a side effect of ACE inhibitor medications. |
| Pharmacodynamics | Ramipril is an ACE inhibitor similar to benazepril, fosinopril and quinapril. It is an inactive prodrug that is converted to ramiprilat in the liver, the main site of activation, and kidneys. Ramiprilat confers blood pressure lowing effects by antagonizing 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 the effects of ramiprilat by causing increased vasodilation and decreased blood pressure. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Angiotensin-converting enzyme | Humans | inhibitor |
| B1 bradykinin receptor | Humans |
ADME / PK
| Absorption | The extent of absorption is at least 50-60%.[FDA Label]. Food decreases the rate of absorption from the GI tract without affecting the extent of absorption. The absolute bioavailabilities of ramipril and ramiprilat were 28% and 44%, respectively, when oral administration was compared to intravenous administration. The serum concentration of ramiprilat was unchanged when capsules were opened and the contents dissolved in water, dissolved in apple juice, or suspended in apple sauce. |
|---|---|
| Half-life | Plasma concentrations of ramiprilat decline in a triphasic manner.[FDA Label] Initial rapid decline represents distribution into tissues and has a half life of 2-4 hours. The half life of the apparent elimination phase is 9-18 hours, which is thought to represent clearance of free drug. The half-life of the terminal elimination phase is > 50 hours and thought to represent clearance of drug bound to ACE due to its slow dissociation. The half life of ramiprilat after multiple daily doses (MDDs) is dose-dependent, ranging from 13-17 hours with 5-10 mg MDDs to 27-36 hours for 2.5 mg MDDs. |
| Protein binding | Protein binding of ramipril is about 73% and that of ramiprilat about 56%.[FDA Label] Protein binding is independent of concentration over the range of 0.1μg/mL-10μg/mL |
| Metabolism | Hepatic metabolism accounts for 75% of total ramipril metabolism.[FDA Label] 25% of hepatic metabolism produces the active metabolite ramiprilat via liver esterase enzymes. 100% of renal metabolism converts ramipril to ramiprilat. Other metabolites, diketopiperazine ester, the diketopiperazine acid, and the glucuronides of ramipril and ramiprilat, are inactive. |
| Route of elimination | Following oral administration, about 60% of the dose is eliminated in the urine as unchanged ramipril (<2%) and its metabolites. About 40% of the dose is found in the feces, representing both unabsorbed drug and drugs and metabolites eliminated via biliary excretion. The urinary excretion of ramipril may be reduced in patients with impaired renal function. |
| Clearance | The renal clearance of ramipril and ramiprilat was reported to be 7.2 and 77.4 mL/min/1.73m<sup>2</sup>. The mean renal clearance of ramipril and ramiprilat is reported to be 10.7 and 126.8 mL/min in healthy elderly patients with normal renal function, additionally the Cmax of ramiprilat is approximately 20% higher in this population. While the pharmacokinetics of ramipril appear unaffected by reduced renal function, the plasma concentration and half-life of ramiprilat are increased. In patient's with hepatic failure the concentration of ramipril is initially increased while the tmax of ramiprilat is prolonged due to a reduced ability to metabolize the drug. However, steady state concentrations of ramiprilat are the same in hepatic failure as in healthy patients. |
Formulation & handling
- Oral small‑molecule API with low aqueous solubility, often requiring solubility‑enhancing approaches for robust tablet or capsule performance.
- Moisture‑sensitive prodrug prone to hydrolysis; handling typically requires low‑humidity conditions and protective packaging.
- Food does not affect absorption, but formulations should avoid excipients or co‑formulated components that elevate potassium levels.
Regulatory status
| Lifecycle | Most key U.S. and Canadian patents expired between 2012 and 2020, indicating that the API is now in a post‑exclusivity phase. With products already marketed in both Canada and the United States, the API is in a mature, likely fully generic market environment. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Ramipril’s supply landscape includes multiple originator patents that have now expired in both the US and Canada, with current production dominated by numerous generic manufacturers and extensive repackaging activity. Branded products have historical presence in North American markets, but the broad list of generic producers indicates well‑established global availability beyond the US and EU. Patent expiries through 2020 support the mature state of generic competition already seen in the market. |
|---|
Safety
| Toxicity | Symptoms of overdose may include excessive peripheral vasodilation (with marked hypotension and shock), bradycardia, electrolyte disturbances, and renal failure. Cases of ACE inhibitor induced hepatotoxicity have been reported in humans and presented as acute jaundice and elevated liver enzymes.Removal of the ACE inhbitor resulted in a decline in liver enzymes and re-challenge produced a subsequent increase. There were no observed tumerogenic effects at chronic doses up to 500mg/kg/day to rats for 24 months or at doses up to 1000mg/kg/day to mice for 18 months. For both species doses were administered by gavage and equivalent to 200 time the maximum recommended human exposure based on body surface area. No mutagenic activity was detected in the Ames test in bacteria, the micronucleus test in mice, unscheduled DNA synthesis in a human cell line, or a forward gene-mutation assay in a Chinese hamster ovary cell line. Several metabolites of ramipril also produced negative results in the Ames test. No effects on fertility were seen in rats at doses up to 500mg/kg/day. No teratogenicity was observed in rats and cynomolgus monkeys at doses 400 times the maximum recommended human exposure nor in rabbites at 2 times the maximum recommended human exposure. LD<sub>50</sub> 10 g/kg (rat).[MSDS] LD<sub>50</sub> 10.5 g/kg (mouse).[MSDS] LD<sub>50</sub> 1 g/kg (dog).[MSDS] |
|---|
High Level Warnings:
- Overdose is associated with pronounced peripheral vasodilation, severe hypotension, bradycardia, electrolyte imbalance, and potential renal impairment
- Hepatotoxicity has been reported, characterized by acute jaundice and elevated hepatic enzymes
- High-dose chronic exposure in rodents showed no tumorigenic or mutagenic activity across standard assays, and reproductive and developmental studies demonstrated no fertility or teratogenic effects at multiples of human exposure
Ramipril 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.
Ramipril (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.
Ramipril API manufacturers & distributors
Compare qualified Ramipril API suppliers worldwide. We currently have 12 companies offering Ramipril API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Arch Pharmalabs | Producer | India | Unknown | CEP, CoA, FDA, GMP | 19 products |
| Cipla | Producer | India | India | CEP, CoA, USDMF, WC | 164 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Hetero Labs | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 90 products |
| Lupin | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 155 products |
| Sanofi | Producer | France | Unknown | CEP, CoA, GMP | 93 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 762 products |
| Sun Pharma | Producer | India | India | CEP, CoA, WC | 219 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 140 products |
| Zhejiang Changming | Producer | China | China | CEP, CoA, FDA, GMP | 19 products |
When sending a request, specify which Ramipril 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 Ramipril 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 Ramipril API
Sourcing
What matters most when sourcing GMP-grade Ramipril?
Key considerations include confirming that the manufacturer complies with GMP standards recognized in the US and Canada and can provide complete regulatory documentation for these markets. Given the mature generic landscape and repackaging activity, supply chain transparency and verification of the actual manufacturing site are important. It is also essential to assess the reliability of long‑term supply, as numerous generic producers contribute to broad global availability.
Which documents are typically required when sourcing Ramipril API?
Request the core API documentation set: CoA (11 companies), CEP (9 companies), GMP (8 companies), FDA (6 companies), WC (5 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Ramipril API?
Known or reported manufacturers for Ramipril: Sinoway industrial Co.,Ltd, Tenatra Exports Private Limited. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Ramipril API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Ramipril manufacturers?
Audit reports may be requested for Ramipril: 5 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Ramipril API on Pharmaoffer?
Reported supplier count for Ramipril: 11 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Ramipril API?
Production countries reported for Ramipril: India (7 producers), China (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Ramipril usually hold?
Common certifications for Ramipril suppliers: CoA (11 companies), CEP (9 companies), GMP (8 companies), FDA (6 companies), WC (5 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Ramipril (CAS 87333-19-5) used for?
Ramipril is used to treat mild to severe hypertension, reduce cardiovascular mortality after myocardial infarction in stable patients with heart failure signs, and lower cardiovascular risk in high‑risk individuals. It is also used to slow the progression of renal disease in patients with hypertension, diabetes, and microalbuminuria or established nephropathy.
Which therapeutic class does Ramipril fall into?
Ramipril belongs to the following therapeutic categories: ACE Inhibitors and Calcium Channel Blockers, ACE Inhibitors and Diuretics, Agents Acting on the Renin-Angiotensin System, Agents causing angioedema, Agents causing hyperkalemia. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Ramipril mainly prescribed for?
The primary indications for Ramipril: For the management of mild to severe hypertension, May be used to reduce cardiovascular mortality following myocardial infarction in hemodynamically stable individuals who develop clinical signs of congestive heart failure within a few days following myocardial infarction, [FDA Label] To reduce the rate of death, myocardial infarction and stroke in individuals at high risk of cardiovascular events, May be used to slow the progression of renal disease in individuals with hypertension, diabetes mellitus and microalubinuria or overt nephropathy. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Ramipril work?
Ramipril inhibits the RAAS system by binding to and inhibiting ACE thereby preventing the conversion of angiotensin I to angiotensin II. As plasma levels of angiotensin II fall, less activation of the G-protein coupled receptors angiotensin receptor I (AT1R) and angiotensin receptor II (AT2R) occurs.
AT1R mediates vasoconstriction, inflammation, fibrosis, and oxidative stress through a variety of signaling pathways. These include Gq coupling to the inositol triphosphate pathway, activation of phospholipases C, A2, and D which contribute to eicosanoid production, activation of Ca2+-dependent and MAP kinases, Gi and G12/13, and eventual activation of the Jak/STAT pathway leading to cell growth and production of extracellular matrix components. AT1R activation also leads to increased activity of membrane-bound NADH/NADPH oxidase which contributes to production of reactive oxygen species. Decreased activation of this receptor mediates the renoprotective, antihypertensive, and cardioprotective effects of Ramipril by reducing inflammation and vasoconstriction.
AT2R acts in opposition to the effects of AT1R by activating phosphotyrosine phosphatases which inhibit MAP kinases, inhibiting Ca2+ channel opening, and stimulating cGMP and nitric oxide production leading to vasodilation. These counteracting effects are shared by the Mas receptor which is activated by Ang(1-7), a subtype of angiotensin produced by plasma esterases from AngI or by ACE2 from AngII produced through a secondary pathway by tonin and cathepsin G. Ang(1-7) also activates AT2R although the bulk of its effect is mediated by MasR.
ACE is also responsible for the breakdown of bradykinin. The resulting buildup of bradykinin due to ACE inhibition is thought to mediate the characteristic dry-cough as a side effect of ACE inhibitor medications.
What should someone know about the safety or toxicity profile of Ramipril?
Ramipril can cause hypotension, hyperkalemia, renal function decline in susceptible individuals, and angioedema; cough is common due to bradykinin accumulation. Overdose may lead to severe vasodilation, marked hypotension, bradycardia, electrolyte disturbances, and possible renal impairment. Hepatotoxicity has been reported, presenting with acute jaundice and elevated liver enzymes. Animal studies showed no tumorigenic, mutagenic, fertility, or teratogenic effects at exposures above human therapeutic levels, and the drug is contraindicated in pregnancy due to fetal toxicity.
What are important formulation and handling considerations for Ramipril as an API?
Ramipril is a moisture‑sensitive prodrug that hydrolyzes readily, so manufacturing should use low‑humidity environments and protective packaging to preserve stability. Its low aqueous solubility may require solubility‑enhancing strategies to ensure consistent dissolution in tablets or capsules. Because food does not alter overall absorption, release characteristics should remain robust across fed and fasted states. Excipients that may raise potassium levels should be avoided to prevent clinically relevant interactions.
Is Ramipril a small molecule?
Ramipril is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Ramipril?
Yes. Ramipril is a moisture‑sensitive prodrug that undergoes hydrolysis, so manufacturing and storage require low‑humidity conditions and protective packaging. Its low aqueous solubility can also affect formulation performance, making solubility‑enhancing approaches important for stable tablets or capsules. Excipients that may increase potassium levels should be avoided in the formulation.
Regulatory
Where is Ramipril approved or in use globally?
Ramipril is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Ramipril right now?
Ramipril is approved for use in both the United States and Canada. Its original patent protections have expired, and the drug is marketed in these regions by multiple generic manufacturers.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Ramipril procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Ramipril. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Ramipril included in the PRO Data Insights coverage?
PRO Data Insights coverage for Ramipril: 1814 verified transactions across 447 suppliers and 202 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Ramipril?
Market report availability for Ramipril: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
