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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Thrombin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Thrombin, including repackagers and relabelers. The FDA regulates Thrombin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Thrombin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Thrombin supplier is an individual or a company that provides Thrombin active pharmaceutical ingredient (API) or Thrombin finished formulations upon request. The Thrombin suppliers may include Thrombin API manufacturers, exporters, distributors and traders.
click here to find a list of Thrombin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Thrombin Drug Master File in Japan (Thrombin JDMF) empowers Thrombin 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 Thrombin JDMF during the approval evaluation for pharmaceutical products. At the time of Thrombin 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 Thrombin suppliers with JDMF on PharmaCompass.
A Thrombin CEP of the European Pharmacopoeia monograph is often referred to as a Thrombin Certificate of Suitability (COS). The purpose of a Thrombin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Thrombin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Thrombin to their clients by showing that a Thrombin CEP has been issued for it. The manufacturer submits a Thrombin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Thrombin CEP holder for the record. Additionally, the data presented in the Thrombin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Thrombin DMF.
A Thrombin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Thrombin 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 Thrombin suppliers with CEP (COS) 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 Thrombin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Thrombin 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 Thrombin 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 Thrombin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Thrombin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Thrombin suppliers with NDC on PharmaCompass.
Thrombin 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 Thrombin 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 Thrombin GMP manufacturer or Thrombin GMP API supplier for your needs.
A Thrombin CoA (Certificate of Analysis) is a formal document that attests to Thrombin's compliance with Thrombin specifications and serves as a tool for batch-level quality control.
Thrombin CoA mostly includes findings from lab analyses of a specific batch. For each Thrombin 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.
Thrombin may be tested according to a variety of international standards, such as European Pharmacopoeia (Thrombin EP), Thrombin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Thrombin USP).
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