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Perindopril | CAS No: 82834-16-0 | GMP-certified suppliers
A medication that treats mild to moderate hypertension and heart failure while reducing cardiovascular risk in patients with hypertension or stable coronary artery disease.
Therapeutic categories
Primary indications
- For the treatment of mild to moderate essential hypertension, mild to moderate congestive heart failure, and to reduce the cardiovascular risk of individuals with hypertension or post-myocardial infarction and stable coronary disease
Product Snapshot
- Perindopril is formulated primarily as oral tablets, including film-coated, coated, orally disintegrating, and extended-release forms
- It is indicated for the management of mild to moderate essential hypertension, mild to moderate congestive heart failure, and to reduce cardiovascular risk in patients with hypertension or post-myocardial infarction and stable coronary disease
- Perindopril is approved for use in regulatory markets including the US and Canada
Clinical Overview
Clinically, perindopril is indicated for the management of mild to moderate essential hypertension and mild to moderate congestive heart failure. It is also prescribed to reduce cardiovascular risk in patients with hypertension, post-myocardial infarction, or stable coronary artery disease.
Pharmacodynamically, perindoprilat lowers blood pressure through inhibition of ATII formation, which otherwise promotes vasoconstriction, aldosterone-mediated sodium and water retention, and vasopressin release—all mechanisms contributing to increased vascular resistance and volume expansion. ACE inhibition also decreases degradation of bradykinin, a vasodilator peptide, potentially enhancing vasodilation. The active site of ACE contains two functional domains (N and C domains); perindoprilat displays higher affinity for the C-domain, primarily involved in blood pressure regulation. Inhibition of ACE leads to increased plasma renin activity, attributed to disrupted negative feedback from reduced ATII levels.
Key pharmacokinetic aspects include extensive first-pass metabolism, yielding perindoprilat, and renal elimination. The pharmacological effects depend on the sustained presence of the active metabolite.
Safety considerations include the risk of angioedema, hyperkalemia, and renal function impairment. These necessitate monitoring in susceptible populations, such as those with renal dysfunction, electrolyte imbalances, or concomitant medications that affect potassium levels. ACE inhibitors, including perindopril, are contraindicated in pregnancy due to teratogenic risk.
Perindopril is marketed under various brand names globally and is often included in combination therapies with calcium channel blockers or diuretics.
From an API sourcing perspective, attention should be paid to the purity and stability of perindopril, given its prodrug nature and metabolic activation. Compliance with regulatory standards for GMP, impurity profiling, and established analytical methods is critical to ensure batch-to-batch consistency and therapeutic reliability.
Identification & chemistry
| Generic name | Perindopril |
|---|---|
| Molecule type | Small molecule |
| CAS | 82834-16-0 |
| UNII | Y5GMK36KGY |
| DrugBank ID | DB00790 |
Pharmacology
| Summary | Perindopril is an angiotensin-converting enzyme (ACE) inhibitor that reduces blood pressure by blocking the conversion of angiotensin I to angiotensin II, thereby antagonizing the renin-angiotensin-aldosterone system (RAAS). It preferentially inhibits the C-domain of somatic ACE, decreasing vasoconstriction and aldosterone-mediated sodium and water retention. Additionally, perindopril increases bradykinin levels by inhibiting its degradation, contributing to vasodilation. |
|---|---|
| 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. Perindoprilat, the active metabolite of perindopril, 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. Perindopril 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. |
| Pharmacodynamics | Perindopril is a nonsulfhydryl prodrug that is metabolized via first pass effect (62%) and systemic hydrolysis (38%) to perindoprilat, its active metabolite, following oral administration. Perindoprilat lowers blood pressure 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 perindoprilat by causing increased vasodilation and decreased blood pressure. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Angiotensin-converting enzyme | Humans | inhibitor |
| Secreted frizzled-related protein 4 | Humans | inhibitor |
ADME / PK
| Absorption | Rapidly absorbed with peak plasma concentrations occurring approximately 1 hour after oral administration. Bioavailability is 65-75%. Following absorption, perindopril is hydrolyzed to perindoprilat, which has an average bioavailability of 20%. The rate and extent of absorption is unaffected by food. However, food decreases the extent of biotransformation to peridoprilat and reduces its bioavailability by 35%. |
|---|---|
| Half-life | Perindopril, 1.2 hours; Peridoprilat, 30-120 hours. The long half life of peridoprilat is due to its slow dissociation from ACE binding sites. |
| Protein binding | Perindoprilat, 10-20% bound to plasma proteins |
| Metabolism | Extensively metabolized, with only 4-12% of the dose recovered in urine following oral administration. Six metabolites have been identified: perindoprilat, perindopril glucuronide, perindoprilat glucuronide, a perindopril lactam, and two perindoprilat lactams. Only perindoprilat is pharmacologically active. Peridoprilat and perindoprilat glucuronide are the two main circulating metabolites. |
| Route of elimination | Perindopril is extensively metabolized following oral administration, with only 4 to 12% of the dose recovered unchanged in the urine. |
| Clearance | * 219 - 362 mL/min [oral administration] |
Formulation & handling
- Perindopril is a small molecule dipeptide administered orally, available primarily as coated or film-coated tablets.
- The API exhibits moderate water solubility and low lipophilicity (LogP 0.63), supporting oral bioavailability without food effect on absorption.
- Formulate with caution regarding potassium content and salt, as these can impact efficacy and safety related to hyperkalemia risk.
Regulatory status
| Lifecycle | The API is in a mature market phase in the United States with key patents expiring between 2009 and 2023, while in Canada, patent protections have recently expired or are upcoming, reflecting a transition towards broader generic accessibility. Remaining patents extend exclusivity in the US until 2029, indicating ongoing market protection in that region. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The perindopril supply chain includes multiple manufacturers and packagers with both originator and generic companies involved, reflecting a competitive manufacturing landscape. Branded products under the name Aceon have a presence primarily in the US and Canadian markets. Patent expirations between 2018 and 2029 indicate a mix of existing and potential upcoming generic competition in these regions. |
|---|
Safety
| Toxicity | The most likely symptom of overdose is severe hypotension. The most common adverse effects observed in controlled clinical trials include cough, digestive symptoms, fatigue, headache, and dizziness. |
|---|
- Overdose may result in severe hypotension requiring immediate medical intervention
- Common adverse effects include cough, gastrointestinal disturbances, fatigue, headache, and dizziness
- Use appropriate protective measures to minimize exposure during handling due to potential systemic effects
Perindopril 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.
Perindopril (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.
Perindopril API manufacturers & distributors
Compare qualified Perindopril API suppliers worldwide. We currently have 17 companies offering Perindopril 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 |
|---|---|---|---|---|---|
| Apotex Pharmachem | Producer | India | India | CEP, CoA, FDA, USDMF, WC | 10 products |
| Arch Pharmalabs | Producer | India | Unknown | CEP, CoA, FDA, GMP | 19 products |
| Asahi Kasei | Producer | Japan | Japan | CoA, JDMF | 3 products |
| Cipla | Producer | India | India | CoA, GMP, USDMF, WC | 164 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hetero Drugs | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 98 products |
| Lupin | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 155 products |
| Menovo | Producer | China | China | CoA, EDMF/ASMF, FDA, GMP, WC | 27 products |
| Mylan | Producer | India | Unknown | CEP, CoA, USDMF, WC | 201 products |
| Piramal Healthcare | Producer | United Kingdom | India | CoA, GMP, WC | 31 products |
| Piramal Pharma Solutions | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 44 products |
| Quimica Sintetica | Producer | Spain | Spain | CoA, GMP | 51 products |
| Rolabo Outsourcing | Producer | Spain | Spain | CEP, CoA, GMP | 11 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Zhejiang Changming | Producer | China | China | CoA, WC | 19 products |
When sending a request, specify which Perindopril 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 Perindopril 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.
