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API SUPPLIERS
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ABOUT THIS PAGE
A Phosphatidylcholines manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phosphatidylcholines, including repackagers and relabelers. The FDA regulates Phosphatidylcholines manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phosphatidylcholines 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 Phosphatidylcholines manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phosphatidylcholines supplier is an individual or a company that provides Phosphatidylcholines active pharmaceutical ingredient (API) or Phosphatidylcholines finished formulations upon request. The Phosphatidylcholines suppliers may include Phosphatidylcholines API manufacturers, exporters, distributors and traders.
click here to find a list of Phosphatidylcholines suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phosphatidylcholines DMF (Drug Master File) is a document detailing the whole manufacturing process of Phosphatidylcholines active pharmaceutical ingredient (API) in detail. Different forms of Phosphatidylcholines DMFs exist exist since differing nations have different regulations, such as Phosphatidylcholines USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phosphatidylcholines DMF submitted to regulatory agencies in the US is known as a USDMF. Phosphatidylcholines USDMF includes data on Phosphatidylcholines's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phosphatidylcholines USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phosphatidylcholines 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 Phosphatidylcholines Drug Master File in Japan (Phosphatidylcholines JDMF) empowers Phosphatidylcholines 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 Phosphatidylcholines JDMF during the approval evaluation for pharmaceutical products. At the time of Phosphatidylcholines 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 Phosphatidylcholines suppliers with JDMF on PharmaCompass.
Phosphatidylcholines 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 Phosphatidylcholines 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 Phosphatidylcholines GMP manufacturer or Phosphatidylcholines GMP API supplier for your needs.
A Phosphatidylcholines CoA (Certificate of Analysis) is a formal document that attests to Phosphatidylcholines's compliance with Phosphatidylcholines specifications and serves as a tool for batch-level quality control.
Phosphatidylcholines CoA mostly includes findings from lab analyses of a specific batch. For each Phosphatidylcholines 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.
Phosphatidylcholines may be tested according to a variety of international standards, such as European Pharmacopoeia (Phosphatidylcholines EP), Phosphatidylcholines JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Phosphatidylcholines USP).
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