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ABOUT THIS PAGE
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PharmaCompass offers a list of Josamycin 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 Josamycin manufacturer or Josamycin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Josamycin manufacturer or Josamycin supplier.
PharmaCompass also assists you with knowing the Josamycin API Price utilized in the formulation of products. Josamycin API Price is not always fixed or binding as the Josamycin Price is obtained through a variety of data sources. The Josamycin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Josacine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Josacine, including repackagers and relabelers. The FDA regulates Josacine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Josacine 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 Josacine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Josacine supplier is an individual or a company that provides Josacine active pharmaceutical ingredient (API) or Josacine finished formulations upon request. The Josacine suppliers may include Josacine API manufacturers, exporters, distributors and traders.
click here to find a list of Josacine 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 Josacine Drug Master File in Japan (Josacine JDMF) empowers Josacine 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 Josacine JDMF during the approval evaluation for pharmaceutical products. At the time of Josacine 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 Josacine suppliers with JDMF on PharmaCompass.
A Josacine CEP of the European Pharmacopoeia monograph is often referred to as a Josacine Certificate of Suitability (COS). The purpose of a Josacine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Josacine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Josacine to their clients by showing that a Josacine CEP has been issued for it. The manufacturer submits a Josacine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Josacine CEP holder for the record. Additionally, the data presented in the Josacine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Josacine DMF.
A Josacine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Josacine 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 Josacine suppliers with CEP (COS) on PharmaCompass.
Josacine 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 Josacine 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 Josacine GMP manufacturer or Josacine GMP API supplier for your needs.
A Josacine CoA (Certificate of Analysis) is a formal document that attests to Josacine's compliance with Josacine specifications and serves as a tool for batch-level quality control.
Josacine CoA mostly includes findings from lab analyses of a specific batch. For each Josacine 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.
Josacine may be tested according to a variety of international standards, such as European Pharmacopoeia (Josacine EP), Josacine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Josacine USP).
