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| Molecular Weight | 1893.7 g/mol |
|---|---|
| Molecular Formula | C89H99Cl2N9O33 |
| XLogP3 | 0.8 |
| Hydrogen Bond Donor Count | 24 |
| Hydrogen Bond Acceptor Count | 34 |
| Rotatable Bond Count | 20 |
| Exact Mass | 1891.5722320 g/mol |
| Monoisotopic Mass | 1891.5722320 g/mol |
| Topological Polar Surface Area | 662 Ų |
| Heavy Atom Count | 133 |
| Formal Charge | 0 |
| Complexity | 3960 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 23 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
API SUPPLIERS
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USDMF
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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FDF Dossiers
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Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Teicoplanin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Teicoplanin, including repackagers and relabelers. The FDA regulates Teicoplanin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Teicoplanin 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 Teicoplanin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Teicoplanin supplier is an individual or a company that provides Teicoplanin active pharmaceutical ingredient (API) or Teicoplanin finished formulations upon request. The Teicoplanin suppliers may include Teicoplanin API manufacturers, exporters, distributors and traders.
click here to find a list of Teicoplanin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Teicoplanin DMF (Drug Master File) is a document detailing the whole manufacturing process of Teicoplanin active pharmaceutical ingredient (API) in detail. Different forms of Teicoplanin DMFs exist exist since differing nations have different regulations, such as Teicoplanin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Teicoplanin DMF submitted to regulatory agencies in the US is known as a USDMF. Teicoplanin USDMF includes data on Teicoplanin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Teicoplanin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Teicoplanin suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Teicoplanin Drug Master File in Japan (Teicoplanin JDMF) empowers Teicoplanin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Teicoplanin JDMF during the approval evaluation for pharmaceutical products. At the time of Teicoplanin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Teicoplanin suppliers with JDMF 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 Teicoplanin Drug Master File in Korea (Teicoplanin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Teicoplanin. The MFDS reviews the Teicoplanin KDMF as part of the drug registration process and uses the information provided in the Teicoplanin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Teicoplanin 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 Teicoplanin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Teicoplanin suppliers with KDMF on PharmaCompass.
A Teicoplanin CEP of the European Pharmacopoeia monograph is often referred to as a Teicoplanin Certificate of Suitability (COS). The purpose of a Teicoplanin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Teicoplanin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Teicoplanin to their clients by showing that a Teicoplanin CEP has been issued for it. The manufacturer submits a Teicoplanin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Teicoplanin CEP holder for the record. Additionally, the data presented in the Teicoplanin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Teicoplanin DMF.
A Teicoplanin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Teicoplanin 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 Teicoplanin suppliers with CEP (COS) on PharmaCompass.
A Teicoplanin written confirmation (Teicoplanin WC) is an official document issued by a regulatory agency to a Teicoplanin manufacturer, verifying that the manufacturing facility of a Teicoplanin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Teicoplanin APIs or Teicoplanin finished pharmaceutical products to another nation, regulatory agencies frequently require a Teicoplanin WC (written confirmation) as part of the regulatory process.
click here to find a list of Teicoplanin suppliers with Written Confirmation (WC) on PharmaCompass.
Teicoplanin 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 Teicoplanin 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 Teicoplanin GMP manufacturer or Teicoplanin GMP API supplier for your needs.
A Teicoplanin CoA (Certificate of Analysis) is a formal document that attests to Teicoplanin's compliance with Teicoplanin specifications and serves as a tool for batch-level quality control.
Teicoplanin CoA mostly includes findings from lab analyses of a specific batch. For each Teicoplanin 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.
Teicoplanin may be tested according to a variety of international standards, such as European Pharmacopoeia (Teicoplanin EP), Teicoplanin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Teicoplanin USP).
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