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| Molecular Weight | 295.29 g/mol |
|---|---|
| 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 |
API SUPPLIERS
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EU WC
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Entecavir Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Entecavir Monohydrate, including repackagers and relabelers. The FDA regulates Entecavir Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Entecavir Monohydrate 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 Entecavir Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Entecavir Monohydrate supplier is an individual or a company that provides Entecavir Monohydrate active pharmaceutical ingredient (API) or Entecavir Monohydrate finished formulations upon request. The Entecavir Monohydrate suppliers may include Entecavir Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Entecavir Monohydrate 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 Entecavir Monohydrate Drug Master File in Korea (Entecavir Monohydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Entecavir Monohydrate. The MFDS reviews the Entecavir Monohydrate KDMF as part of the drug registration process and uses the information provided in the Entecavir Monohydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Entecavir Monohydrate 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 Entecavir Monohydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Entecavir Monohydrate suppliers with KDMF on PharmaCompass.
A Entecavir Monohydrate written confirmation (Entecavir Monohydrate WC) is an official document issued by a regulatory agency to a Entecavir Monohydrate manufacturer, verifying that the manufacturing facility of a Entecavir Monohydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Entecavir Monohydrate APIs or Entecavir Monohydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Entecavir Monohydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Entecavir Monohydrate suppliers with Written Confirmation (WC) on PharmaCompass.
Entecavir Monohydrate 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 Entecavir Monohydrate 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 Entecavir Monohydrate GMP manufacturer or Entecavir Monohydrate GMP API supplier for your needs.
A Entecavir Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Entecavir Monohydrate's compliance with Entecavir Monohydrate specifications and serves as a tool for batch-level quality control.
Entecavir Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Entecavir Monohydrate 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.
Entecavir Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Entecavir Monohydrate EP), Entecavir Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Entecavir Monohydrate USP).
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