API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
0
Europe
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
17
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 .Lecithin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of .Lecithin, including repackagers and relabelers. The FDA regulates .Lecithin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. .Lecithin 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 .Lecithin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A .Lecithin supplier is an individual or a company that provides .Lecithin active pharmaceutical ingredient (API) or .Lecithin finished formulations upon request. The .Lecithin suppliers may include .Lecithin API manufacturers, exporters, distributors and traders.
click here to find a list of .Lecithin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A .Lecithin DMF (Drug Master File) is a document detailing the whole manufacturing process of .Lecithin active pharmaceutical ingredient (API) in detail. Different forms of .Lecithin DMFs exist exist since differing nations have different regulations, such as .Lecithin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A .Lecithin DMF submitted to regulatory agencies in the US is known as a USDMF. .Lecithin USDMF includes data on .Lecithin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The .Lecithin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of .Lecithin 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 .Lecithin Drug Master File in Japan (.Lecithin JDMF) empowers .Lecithin 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 .Lecithin JDMF during the approval evaluation for pharmaceutical products. At the time of .Lecithin 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 .Lecithin suppliers with JDMF on PharmaCompass.
.Lecithin 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 .Lecithin 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 .Lecithin GMP manufacturer or .Lecithin GMP API supplier for your needs.
A .Lecithin CoA (Certificate of Analysis) is a formal document that attests to .Lecithin's compliance with .Lecithin specifications and serves as a tool for batch-level quality control.
.Lecithin CoA mostly includes findings from lab analyses of a specific batch. For each .Lecithin 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.
.Lecithin may be tested according to a variety of international standards, such as European Pharmacopoeia (.Lecithin EP), .Lecithin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (.Lecithin USP).