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1. Perindopril L-arginine
2. 612548-45-5
3. Tft5im1kgb
4. Chebi:77655
5. (2s,3as,7as)-1-[(2s)-2-[[(2s)-1-ethoxy-1-oxopentan-2-yl]amino]propanoyl]-2,3,3a,4,5,6,7,7a-octahydroindole-2-carboxylic Acid;(2s)-2-amino-5-(diaminomethylideneamino)pentanoic Acid
6. (2s,3as,7as)-1-((s)-2-(((s)-1-ethoxy-1-oxopentan-2-yl)amino)propanoyl)octahydro-1h-indole-2-carboxylic Acid Compound With (s)-2-amino-5-guanidinopentanoic Acid (1:1)
7. L-arginine, (2s,3as,7as)-1-((2s)-2-(((1s)-1-(ethoxycarbonyl)butyl)amino)-1-oxopropyl)octahydro-1h-indole-2-carboxylate (1:1)
8. Unii-tft5im1kgb
9. Perindopril (l)-arginine
10. Perindopril L-arginine Salt
11. Chembl3544986
12. Schembl15090777
13. Dtxsid70210159
14. Perindopril Arginine [who-dd]
15. Perindopril Arginine [orange Book]
16. D11580
17. Q27147249
| Molecular Weight | 542.7 g/mol |
|---|---|
| Molecular Formula | C25H46N6O7 |
| Hydrogen Bond Donor Count | 6 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 14 |
| Exact Mass | 542.34279783 g/mol |
| Monoisotopic Mass | 542.34279783 g/mol |
| Topological Polar Surface Area | 224 Ų |
| Heavy Atom Count | 38 |
| Formal Charge | 0 |
| Complexity | 700 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 6 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
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Average Price (USD/KGS) |
Number of Transactions |
|---|
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FDF Dossiers
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DOSAGE - TABLET;ORAL - EQ 10MG BASE;14MG
USFDA APPLICATION NUMBER - 205003
DOSAGE - TABLET;ORAL - EQ 2.5MG BASE;3.5MG
USFDA APPLICATION NUMBER - 205003
DOSAGE - TABLET;ORAL - EQ 5MG BASE;7MG
USFDA APPLICATION NUMBER - 205003
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Patents & EXCLUSIVITIES
US Patents
Patent Expiration Date : 2029-10-05
AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
US Patent Number : 7846961
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 205003
Patent Use Code : U-3
Delist Requested :
Patent Use Description : TREATMENT OF HYPERTENS...
Patent Expiration Date : 2029-10-05
Patent Expiration Date : 2029-10-05
AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
US Patent Number : 7846961
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 205003
Patent Use Code : U-3
Delist Requested :
Patent Use Description : TREATMENT OF HYPERTENS...
Patent Expiration Date : 2029-10-05
Patent Expiration Date : 2029-10-05
AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
US Patent Number : 7846961
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 205003
Patent Use Code : U-3
Delist Requested :
Patent Use Description : TREATMENT OF HYPERTENS...
Patent Expiration Date : 2029-10-05
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Health Canada Patents
Patent Expiration Date : 2023-04-03
Date Granted : 2006-02-21
Brand Name : ARCOSYL
Patent Number : 2423825
Filing Date : 2003-04-03
Strength per Unit : 2.5 mg
Dosage Form : Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2023-04-03
Date Granted : 2006-02-21
Patent Expiration Date : 2023-04-03
Date Granted : 2006-02-21
Brand Name : ARCOSYL
Patent Number : 2423825
Filing Date : 2003-04-03
Strength per Unit : 5 mg
Dosage Form : Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2023-04-03
Date Granted : 2006-02-21
Patent Expiration Date : 2023-04-03
Date Granted : 2006-02-21
Brand Name : ARCOSYL
Patent Number : 2423825
Filing Date : 2003-04-03
Strength per Unit : 10 mg
Dosage Form : Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2023-04-03
Date Granted : 2006-02-21
Patent Expiration Date : 2018-03-06
Date Granted : 2001-03-06
Brand Name : ARCOSYL
Patent Number : 1341196
Filing Date : 1981-10-01
Strength per Unit : 2.5 mg
Dosage Form : Orally Disintegrating Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2018-03-06
Date Granted : 2001-03-06
Patent Expiration Date : 2023-04-03
Date Granted : 2006-02-21
Brand Name : ARCOSYL
Patent Number : 2423825
Filing Date : 2003-04-03
Strength per Unit : 2.5 mg
Dosage Form : Orally Disintegrating Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2023-04-03
Date Granted : 2006-02-21
Patent Expiration Date : 2018-03-06
Date Granted : 2001-03-06
Brand Name : ARCOSYL
Patent Number : 1341196
Filing Date : 1981-10-01
Strength per Unit : 5 mg
Dosage Form : Orally Disintegrating Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2018-03-06
Date Granted : 2001-03-06
Patent Expiration Date : 2023-04-03
Date Granted : 2006-02-21
Brand Name : ARCOSYL
Patent Number : 2423825
Filing Date : 2003-04-03
Strength per Unit : 5 mg
Dosage Form : Orally Disintegrating Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2023-04-03
Date Granted : 2006-02-21
Patent Expiration Date : 2018-03-06
Date Granted : 2001-03-06
Brand Name : ARCOSYL
Patent Number : 1341196
Filing Date : 1981-10-01
Strength per Unit : 10 mg
Dosage Form : Orally Disintegrating Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2018-03-06
Date Granted : 2001-03-06
Patent Expiration Date : 2023-04-03
Date Granted : 2006-02-21
Brand Name : ARCOSYL
Patent Number : 2423825
Filing Date : 2003-04-03
Strength per Unit : 10 mg
Dosage Form : Orally Disintegrating Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2023-04-03
Date Granted : 2006-02-21
Patent Expiration Date : 2018-03-06
Date Granted : 2001-03-06
Brand Name : ARCOSYL
Patent Number : 1341196
Filing Date : 1981-10-01
Strength per Unit : 2.5 mg
Dosage Form : Tablet
Human Or VET : Human
Route of Administration : Oral
Patent Expiration Date : 2018-03-06
Date Granted : 2001-03-06
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
A Perindopril Arginine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perindopril Arginine, including repackagers and relabelers. The FDA regulates Perindopril Arginine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perindopril Arginine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Perindopril Arginine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Perindopril Arginine supplier is an individual or a company that provides Perindopril Arginine active pharmaceutical ingredient (API) or Perindopril Arginine finished formulations upon request. The Perindopril Arginine suppliers may include Perindopril Arginine API manufacturers, exporters, distributors and traders.
click here to find a list of Perindopril Arginine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Perindopril Arginine DMF (Drug Master File) is a document detailing the whole manufacturing process of Perindopril Arginine active pharmaceutical ingredient (API) in detail. Different forms of Perindopril Arginine DMFs exist exist since differing nations have different regulations, such as Perindopril Arginine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Perindopril Arginine DMF submitted to regulatory agencies in the US is known as a USDMF. Perindopril Arginine USDMF includes data on Perindopril Arginine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Perindopril Arginine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Perindopril Arginine suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Perindopril Arginine Drug Master File in Korea (Perindopril Arginine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Perindopril Arginine. The MFDS reviews the Perindopril Arginine KDMF as part of the drug registration process and uses the information provided in the Perindopril Arginine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Perindopril Arginine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Perindopril Arginine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Perindopril Arginine suppliers with KDMF on PharmaCompass.
A Perindopril Arginine written confirmation (Perindopril Arginine WC) is an official document issued by a regulatory agency to a Perindopril Arginine manufacturer, verifying that the manufacturing facility of a Perindopril Arginine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Perindopril Arginine APIs or Perindopril Arginine finished pharmaceutical products to another nation, regulatory agencies frequently require a Perindopril Arginine WC (written confirmation) as part of the regulatory process.
click here to find a list of Perindopril Arginine suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Perindopril Arginine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Perindopril Arginine API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Perindopril Arginine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Perindopril Arginine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Perindopril Arginine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Perindopril Arginine suppliers with NDC on PharmaCompass.
Perindopril Arginine Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Perindopril Arginine GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Perindopril Arginine GMP manufacturer or Perindopril Arginine GMP API supplier for your needs.
A Perindopril Arginine CoA (Certificate of Analysis) is a formal document that attests to Perindopril Arginine's compliance with Perindopril Arginine specifications and serves as a tool for batch-level quality control.
Perindopril Arginine CoA mostly includes findings from lab analyses of a specific batch. For each Perindopril Arginine CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Perindopril Arginine may be tested according to a variety of international standards, such as European Pharmacopoeia (Perindopril Arginine EP), Perindopril Arginine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Perindopril Arginine USP).
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