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API SUPPLIERS
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
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CEP/COS
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Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
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29 Dec 2023
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26 Dec 2023
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28 Sep 2018
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A Josamycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Josamycin, including repackagers and relabelers. The FDA regulates Josamycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Josamycin 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 Josamycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Josamycin supplier is an individual or a company that provides Josamycin active pharmaceutical ingredient (API) or Josamycin finished formulations upon request. The Josamycin suppliers may include Josamycin API manufacturers, exporters, distributors and traders.
click here to find a list of Josamycin 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 Josamycin Drug Master File in Japan (Josamycin JDMF) empowers Josamycin 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 Josamycin JDMF during the approval evaluation for pharmaceutical products. At the time of Josamycin 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 Josamycin suppliers with JDMF on PharmaCompass.
A Josamycin CEP of the European Pharmacopoeia monograph is often referred to as a Josamycin Certificate of Suitability (COS). The purpose of a Josamycin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Josamycin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Josamycin to their clients by showing that a Josamycin CEP has been issued for it. The manufacturer submits a Josamycin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Josamycin CEP holder for the record. Additionally, the data presented in the Josamycin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Josamycin DMF.
A Josamycin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Josamycin 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 Josamycin suppliers with CEP (COS) on PharmaCompass.
Josamycin 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 Josamycin 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 Josamycin GMP manufacturer or Josamycin GMP API supplier for your needs.
A Josamycin CoA (Certificate of Analysis) is a formal document that attests to Josamycin's compliance with Josamycin specifications and serves as a tool for batch-level quality control.
Josamycin CoA mostly includes findings from lab analyses of a specific batch. For each Josamycin 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.
Josamycin may be tested according to a variety of international standards, such as European Pharmacopoeia (Josamycin EP), Josamycin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Josamycin USP).
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