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PharmaCompass offers a list of Phosphatidylcholines 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 Phosphatidylcholines manufacturer or Phosphatidylcholines supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Phosphatidylcholines manufacturer or Phosphatidylcholines supplier.
PharmaCompass also assists you with knowing the Phosphatidylcholines API Price utilized in the formulation of products. Phosphatidylcholines API Price is not always fixed or binding as the Phosphatidylcholines Price is obtained through a variety of data sources. The Phosphatidylcholines Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Phosphatidylcholine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phosphatidylcholine, including repackagers and relabelers. The FDA regulates Phosphatidylcholine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phosphatidylcholine 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 Phosphatidylcholine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Phosphatidylcholine supplier is an individual or a company that provides Phosphatidylcholine active pharmaceutical ingredient (API) or Phosphatidylcholine finished formulations upon request. The Phosphatidylcholine suppliers may include Phosphatidylcholine API manufacturers, exporters, distributors and traders.
click here to find a list of Phosphatidylcholine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phosphatidylcholine DMF (Drug Master File) is a document detailing the whole manufacturing process of Phosphatidylcholine active pharmaceutical ingredient (API) in detail. Different forms of Phosphatidylcholine DMFs exist exist since differing nations have different regulations, such as Phosphatidylcholine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phosphatidylcholine DMF submitted to regulatory agencies in the US is known as a USDMF. Phosphatidylcholine USDMF includes data on Phosphatidylcholine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phosphatidylcholine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phosphatidylcholine 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 Phosphatidylcholine Drug Master File in Japan (Phosphatidylcholine JDMF) empowers Phosphatidylcholine 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 Phosphatidylcholine JDMF during the approval evaluation for pharmaceutical products. At the time of Phosphatidylcholine 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 Phosphatidylcholine suppliers with JDMF on PharmaCompass.
Phosphatidylcholine 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 Phosphatidylcholine 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 Phosphatidylcholine GMP manufacturer or Phosphatidylcholine GMP API supplier for your needs.
A Phosphatidylcholine CoA (Certificate of Analysis) is a formal document that attests to Phosphatidylcholine's compliance with Phosphatidylcholine specifications and serves as a tool for batch-level quality control.
Phosphatidylcholine CoA mostly includes findings from lab analyses of a specific batch. For each Phosphatidylcholine 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.
Phosphatidylcholine may be tested according to a variety of international standards, such as European Pharmacopoeia (Phosphatidylcholine EP), Phosphatidylcholine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Phosphatidylcholine USP).
