Synopsis
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| Molecular Weight | 539.4 g/mol |
|---|---|
| Molecular Formula | C20H19F6N5O6-2 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 15 |
| Rotatable Bond Count | 5 |
| Exact Mass | 539.12395232 g/mol |
| Monoisotopic Mass | 539.12395232 g/mol |
| Topological Polar Surface Area | 178 Ų |
| Heavy Atom Count | 37 |
| Formal Charge | -2 |
| Complexity | 684 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| 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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ABOUT THIS PAGE
A Sitagliptin Malate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sitagliptin Malate, including repackagers and relabelers. The FDA regulates Sitagliptin Malate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sitagliptin Malate 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 Sitagliptin Malate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sitagliptin Malate supplier is an individual or a company that provides Sitagliptin Malate active pharmaceutical ingredient (API) or Sitagliptin Malate finished formulations upon request. The Sitagliptin Malate suppliers may include Sitagliptin Malate API manufacturers, exporters, distributors and traders.
click here to find a list of Sitagliptin Malate 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 Sitagliptin Malate Drug Master File in Korea (Sitagliptin Malate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sitagliptin Malate. The MFDS reviews the Sitagliptin Malate KDMF as part of the drug registration process and uses the information provided in the Sitagliptin Malate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sitagliptin Malate 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 Sitagliptin Malate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sitagliptin Malate suppliers with KDMF on PharmaCompass.
A Sitagliptin Malate written confirmation (Sitagliptin Malate WC) is an official document issued by a regulatory agency to a Sitagliptin Malate manufacturer, verifying that the manufacturing facility of a Sitagliptin Malate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sitagliptin Malate APIs or Sitagliptin Malate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sitagliptin Malate WC (written confirmation) as part of the regulatory process.
click here to find a list of Sitagliptin Malate suppliers with Written Confirmation (WC) on PharmaCompass.
Sitagliptin Malate 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 Sitagliptin Malate 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 Sitagliptin Malate GMP manufacturer or Sitagliptin Malate GMP API supplier for your needs.
A Sitagliptin Malate CoA (Certificate of Analysis) is a formal document that attests to Sitagliptin Malate's compliance with Sitagliptin Malate specifications and serves as a tool for batch-level quality control.
Sitagliptin Malate CoA mostly includes findings from lab analyses of a specific batch. For each Sitagliptin Malate 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.
Sitagliptin Malate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sitagliptin Malate EP), Sitagliptin Malate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sitagliptin Malate USP).
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