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