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Molecular Weight | 295.29 g/mol |
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Molecular Formula | C12H17N5O4 |
Hydrogen Bond Donor Count | 5 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 2 |
Exact Mass | 295.12805404 g/mol |
Monoisotopic Mass | 295.12805404 g/mol |
Topological Polar Surface Area | 127 A^2 |
Heavy Atom Count | 21 |
Formal Charge | 0 |
Complexity | 480 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 3 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
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PharmaCompass offers a list of Entecavir Monohydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Entecavir Monohydrate manufacturer or Entecavir Monohydrate supplier for your needs.
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A MP-1495 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MP-1495, including repackagers and relabelers. The FDA regulates MP-1495 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MP-1495 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 MP-1495 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A MP-1495 supplier is an individual or a company that provides MP-1495 active pharmaceutical ingredient (API) or MP-1495 finished formulations upon request. The MP-1495 suppliers may include MP-1495 API manufacturers, exporters, distributors and traders.
click here to find a list of MP-1495 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 MP-1495 Drug Master File in Korea (MP-1495 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MP-1495. The MFDS reviews the MP-1495 KDMF as part of the drug registration process and uses the information provided in the MP-1495 KDMF to evaluate the safety and efficacy of the drug.
After submitting a MP-1495 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 MP-1495 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of MP-1495 suppliers with KDMF on PharmaCompass.
A MP-1495 CEP of the European Pharmacopoeia monograph is often referred to as a MP-1495 Certificate of Suitability (COS). The purpose of a MP-1495 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MP-1495 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MP-1495 to their clients by showing that a MP-1495 CEP has been issued for it. The manufacturer submits a MP-1495 CEP (COS) as part of the market authorization procedure, and it takes on the role of a MP-1495 CEP holder for the record. Additionally, the data presented in the MP-1495 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MP-1495 DMF.
A MP-1495 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MP-1495 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of MP-1495 suppliers with CEP (COS) on PharmaCompass.
A MP-1495 written confirmation (MP-1495 WC) is an official document issued by a regulatory agency to a MP-1495 manufacturer, verifying that the manufacturing facility of a MP-1495 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting MP-1495 APIs or MP-1495 finished pharmaceutical products to another nation, regulatory agencies frequently require a MP-1495 WC (written confirmation) as part of the regulatory process.
click here to find a list of MP-1495 suppliers with Written Confirmation (WC) on PharmaCompass.
MP-1495 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 MP-1495 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 MP-1495 GMP manufacturer or MP-1495 GMP API supplier for your needs.
A MP-1495 CoA (Certificate of Analysis) is a formal document that attests to MP-1495's compliance with MP-1495 specifications and serves as a tool for batch-level quality control.
MP-1495 CoA mostly includes findings from lab analyses of a specific batch. For each MP-1495 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.
MP-1495 may be tested according to a variety of international standards, such as European Pharmacopoeia (MP-1495 EP), MP-1495 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MP-1495 USP).