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REF. STANDARDS & IMPURITIES
JP
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
A Berberine Chloride Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Berberine Chloride Hydrate, including repackagers and relabelers. The FDA regulates Berberine Chloride Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Berberine Chloride Hydrate 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 Berberine Chloride Hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Berberine Chloride Hydrate supplier is an individual or a company that provides Berberine Chloride Hydrate active pharmaceutical ingredient (API) or Berberine Chloride Hydrate finished formulations upon request. The Berberine Chloride Hydrate suppliers may include Berberine Chloride Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Berberine Chloride Hydrate 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 Berberine Chloride Hydrate Drug Master File in Japan (Berberine Chloride Hydrate JDMF) empowers Berberine Chloride Hydrate 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 Berberine Chloride Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Berberine Chloride Hydrate 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 Berberine Chloride Hydrate suppliers with JDMF on PharmaCompass.
Berberine Chloride Hydrate 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 Berberine Chloride Hydrate 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 Berberine Chloride Hydrate GMP manufacturer or Berberine Chloride Hydrate GMP API supplier for your needs.
A Berberine Chloride Hydrate CoA (Certificate of Analysis) is a formal document that attests to Berberine Chloride Hydrate's compliance with Berberine Chloride Hydrate specifications and serves as a tool for batch-level quality control.
Berberine Chloride Hydrate CoA mostly includes findings from lab analyses of a specific batch. For each Berberine Chloride Hydrate 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.
Berberine Chloride Hydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Berberine Chloride Hydrate EP), Berberine Chloride Hydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Berberine Chloride Hydrate USP).
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