Top Perindopril Erbumine API Manufacturers in China

1. What is Perindopril erbumine?

1.1. Definition

Perindopril erbumine is the tert-butylamine salt of a third generation long-acting angiotensin-converting enzyme (ACE) inhibitor, perindopril, the free acid form of perindopril erbumine.

Perindopril was firstly discovered in the 1980s and is currently used alone or with other drugs to lower blood pressure in patients with mild to moderate hypertension and cardiovascular diseases, including heart attack, heart failure, and stroke.

Moreover, perindopril erbumine protects and lowers the mortality & morbidity rates in patients with coronary heart disease and provides cardiovascular and renal protection. 

Perindopril erbumine is only available as 2 mg, 4 mg, and 8 mg tablets taken orally once a day.

1.2. Chemical & Physical Properties 

•Chemical structure:

•Synonyms: Perindopril tert-butylamine, t-butylamine 

•Molecular weight: 441.6 g/mol (salt form)

•Molecular formula: C19H32N2O5.C4H11N 

•CAS number: 107133-36-8

•DrugBank Accession number: DB00790

•IUPAC Name: (2S,3aS,7aS)-1-[(2S)-2-[[(1S)-1-(Ethoxycarbonyl)butyl]amino]-1-oxopropyl]octahydro-1H-indole-2-carboxylic acid tert-butylamine salt

•Melting point: 126-128°C

•Storage temperature: 2-8°C

•Form: white to off-white powder

•Solubility: soluble in H2O, chloroform, and alcohol

•Safety profile: Toxic fumes could be emitted after the decomposition of perindopril erbumine caused by high temperature, and intravenous administration is hazardous.

1.3. Brand name: 

ACEON®

2. Mechanism of action of Perindopril erbumine

After its oral administration, perindopril erbumine is metabolized to its active metabolite, perindoprilat, which acts via competitive inhibition of the angiotensin-converting enzyme (ACE).

ACE inhibitor inhibits the conversion of angiotensin I (Ang I) to angiotensin II (Ang II), a potent peripheral vasoconstrictor and part of the renin-angiotensin-aldosterone system (RAAS) that regulates blood pressure. Ang II stimulates vasoconstriction and results in the release of aldosterone from the adrenal cortex and, eventually, an increase in blood pressure. 

Therefore, perindopril erbumine causes blood vessel relaxation, lowers blood pressure, and reduces the risk of cardiovascular events. 

3. Perindopril vs Perindopril erbumine

Perindopril is available only as a generic drug (no brand names), and it exists in two forms of salts: perindopril arginine (Coversyl® Arginine) or perindopril erbumine (Aceon®), both have the same therapeutic effect and safety profile; however, the dosage may vary. 

Perindopril erbumine is a pro-drug, a tert-butylamine salt of perindopril, an ACE inhibitor, and peptidyl dipeptidase A inhibitor.

4. Perindopril erbumine manufacturing process specifications

Perindopril erbumine tablets are available in the dosage of 2 mg, 4 mg, and 8 mg for oral administration. Each tablet contains the Active Pharmaceutical Ingredient (API) powder of perindopril erbumine and other excipients to maintain thermal stability and improve the drug quality and stability. 

These excipients include anhydrous colloidal silica, microcrystalline cellulose, lactose, and magnesium stearate. Moreover, dosages of 4 and 8 mg may also contain iron oxide and aluminum Lake. 

During the manufacturing process, pH value should be maintained in an alkaline range between 7.1-14 to improve stability during the drug preparation.

Perindopril erbumine tablets' shelf life is about two years in places with average temperature. Nevertheless, additional packaging approaches should be achieved in places with high temperature and air humidity which could affect the drug formulation and increase the impurities.

Regarding packaging, containers made with aluminum and certain polymers are preferred to be used as packaging materials to avoid air humidity and eliminate water. 

5. Uses of Perindopril erbumine

Perindopril erbumine for high blood pressure

Perindopril erbumine is used to lower systolic blood pressure (SBP) and diastolic blood pressure (DBP) in patients with mild to moderate essential hypertension (starting dosage is 4 mg once a day, and the maximum dosage is 12 mg).

It is used alone or in combination with other antihypertensive medications such as thiazide diuretics. 

Perindopril erbumine for Stable Coronary Artery Disease (CAD)

Perindopril erbumine is indicated for patients with stable coronary artery disease to lower the risk of developing myocardial infarction and cardiovascular disorders (starting dosage is 4 mg once a day, then it can be increased to a maximum of 8 mg).

Furthermore, perindopril erbumine can be used concurrently with other classic medications used in coronary artery disease, including lipid-lowering medications and antiplatelets.

Perindopril erbumine for congestive heart failure (CHF)

Perindopril erbumine is indicated for patients with mild to moderate congestive heart failure. It causes vasodilatation and reduces left ventricular remodeling, which is the main feature of heart failure (the usual dosage is 4 mg once a day). 

Perindopril erbumine is used adjunctly to diuretic medications, but this should be consulted first with the physician.

Perindopril erbumine for heart attack

Usually, perindopril erbumine is prescribed after having a heart attack or to avoid developing future heart attacks, stroke, and further damage (the usual dosage after having a heart attack is 8 mg once a day).

6. Perindopril erbumine manufacturers in China 

•China Chinopharma Ltd.

China Shanghai Chinopharma (CSC) is a worldwide and well-known supplier of high-quality drug products. Active Pharmaceutical Ingredients imported from India to the Chinese market at an affordable price. 

The company also supply several services in various countries, such as the application of brand names and supplying patents.

Phone number of the supplier: +86-21-54633222

•Zhejiang Huahai Pharmaceutical Co., Ltd.

Zhejiang Huahai Pharmaceuticals company is a large certified manufacturer and supplier of Pharmaceutical services and products in China. The company is the largest supplier of "April" products worldwide, including captopril and enalapril, and the first Chinese company that passed FDA approval. Additionally, the formulation workshops in the company follow international Good Manufacturing Practice (GMP) standards. 

The company has more than 40 branches worldwide, including Japan, India, United States, and Russia)

Phone number of the company: +86-576-85016479

•Hangzhou Huarong Pharmaceutical Co., Ltd

Hangzhou Huarong Pharmaceutical company has 11 years of experience in the manufacturing and developing of the Pharmaceutical industry with high-quality products and services. 

Phone number of the company: +86-571-88801240.

•Shenzhen Bona Pharma Technology Co., Ltd

Shenzhen Bona Pharma Technology company is products are valued in 73 countries from Japan to the Middle east. The company services include Medical packaging and health products; besides, it has five patents in its products.

Phone number of the company: +86-755-26994208

•Haihang Industry Co., Ltd.

Haihang is a worldwide supplier and manufacturer of Pharmaceutical, chemical, and other health-related products. They believe that the core of their work is product quality, and the customers should be offered what they deserve and expect. 

Phone number of the company: +86-531-13386404752

•Shanghai Worldyang Chemical Co., Ltd.

Shanghai Worldyang Chemical Co., Ltd is a well-known perindopril erbumine manufacturers with high-quality services and products exported to India, Japan, North America, Middle East, and currently expanding their services in the global market.

Phone number of the company: +86-21-56795718

•PharmaSources

PharmaSources is a vertical e-commerce online marketplace that serves the pharmaceutical industry. We provide information on high-quality products and suppliers for global customers and deliver services to over 90,000 active members across 211 countries. You could find reliable active pharmaceutical ingredients manufacturers, medical equipment manufacturers, and Medical Equipment manufacturers in PharmaSources. We are featuring more than 1,600,000 products in more than 30 categories spanning the entire pharma supply chain! 

7. Perindopril erbumine substitutes

For many people, perindopril erbumine is considered as the first-line treatment for hypertension; however, side effects of perindopril erbumine and other angiotensin-converting enzymes (ACE) inhibitors such as dry cough or safety concerns in pregnancy (Category C & Category D) could force patients to switch medications to manage hypertension. These medications include angiotensin II receptor antagonists such as candesartan and losartan or calcium channel blockers such as amlodipine. 

8. FAQ

Perindopril tert-butylamine and perindopril erbumine same?

Perindopril tert-butylamine and perindopril erbumine are the same, as perindopril erbumine is the international nonpropritary name of tert-butylamine salt of perindopril.