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CEP/COS
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JDMF
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NDC API
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API SUPPLIERS
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USDMF
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Drugs in Development
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DOSAGE - SOLUTION;INTRAVENOUS - 180MG/18ML (1...DOSAGE - SOLUTION;INTRAVENOUS - 180MG/18ML (10MG/ML)
USFDA APPLICATION NUMBER - 205098
DOSAGE - SOLUTION;INTRAVENOUS - 77.5MG/7.75ML...DOSAGE - SOLUTION;INTRAVENOUS - 77.5MG/7.75ML (10MG/ML)
USFDA APPLICATION NUMBER - 205098
DOSAGE - SOLUTION;INTRAVENOUS - 10MG/2ML (5MG...DOSAGE - SOLUTION;INTRAVENOUS - 10MG/2ML (5MG/ML)
USFDA APPLICATION NUMBER - 21201
DOSAGE - SOLUTION;INTRAVENOUS - 20MG/2ML (10M...DOSAGE - SOLUTION;INTRAVENOUS - 20MG/2ML (10MG/ML)
USFDA APPLICATION NUMBER - 21201
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ABOUT THIS PAGE
A Polidocanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Polidocanol, including repackagers and relabelers. The FDA regulates Polidocanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Polidocanol 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 Polidocanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Polidocanol supplier is an individual or a company that provides Polidocanol active pharmaceutical ingredient (API) or Polidocanol finished formulations upon request. The Polidocanol suppliers may include Polidocanol API manufacturers, exporters, distributors and traders.
click here to find a list of Polidocanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Polidocanol DMF (Drug Master File) is a document detailing the whole manufacturing process of Polidocanol active pharmaceutical ingredient (API) in detail. Different forms of Polidocanol DMFs exist exist since differing nations have different regulations, such as Polidocanol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Polidocanol DMF submitted to regulatory agencies in the US is known as a USDMF. Polidocanol USDMF includes data on Polidocanol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Polidocanol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Polidocanol suppliers with USDMF on PharmaCompass.
Polidocanol 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 Polidocanol 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 Polidocanol GMP manufacturer or Polidocanol GMP API supplier for your needs.
A Polidocanol CoA (Certificate of Analysis) is a formal document that attests to Polidocanol's compliance with Polidocanol specifications and serves as a tool for batch-level quality control.
Polidocanol CoA mostly includes findings from lab analyses of a specific batch. For each Polidocanol 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.
Polidocanol may be tested according to a variety of international standards, such as European Pharmacopoeia (Polidocanol EP), Polidocanol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Polidocanol USP).
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