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ABOUT THIS PAGE
A Pholcodine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pholcodine, including repackagers and relabelers. The FDA regulates Pholcodine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pholcodine 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 Pholcodine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pholcodine supplier is an individual or a company that provides Pholcodine active pharmaceutical ingredient (API) or Pholcodine finished formulations upon request. The Pholcodine suppliers may include Pholcodine API manufacturers, exporters, distributors and traders.
click here to find a list of Pholcodine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pholcodine DMF (Drug Master File) is a document detailing the whole manufacturing process of Pholcodine active pharmaceutical ingredient (API) in detail. Different forms of Pholcodine DMFs exist exist since differing nations have different regulations, such as Pholcodine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pholcodine DMF submitted to regulatory agencies in the US is known as a USDMF. Pholcodine USDMF includes data on Pholcodine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pholcodine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pholcodine suppliers with USDMF on PharmaCompass.
A Pholcodine CEP of the European Pharmacopoeia monograph is often referred to as a Pholcodine Certificate of Suitability (COS). The purpose of a Pholcodine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pholcodine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pholcodine to their clients by showing that a Pholcodine CEP has been issued for it. The manufacturer submits a Pholcodine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pholcodine CEP holder for the record. Additionally, the data presented in the Pholcodine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pholcodine DMF.
A Pholcodine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pholcodine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Pholcodine suppliers with CEP (COS) on PharmaCompass.
A Pholcodine written confirmation (Pholcodine WC) is an official document issued by a regulatory agency to a Pholcodine manufacturer, verifying that the manufacturing facility of a Pholcodine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pholcodine APIs or Pholcodine finished pharmaceutical products to another nation, regulatory agencies frequently require a Pholcodine WC (written confirmation) as part of the regulatory process.
click here to find a list of Pholcodine suppliers with Written Confirmation (WC) on PharmaCompass.
Pholcodine 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 Pholcodine 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 Pholcodine GMP manufacturer or Pholcodine GMP API supplier for your needs.
A Pholcodine CoA (Certificate of Analysis) is a formal document that attests to Pholcodine's compliance with Pholcodine specifications and serves as a tool for batch-level quality control.
Pholcodine CoA mostly includes findings from lab analyses of a specific batch. For each Pholcodine 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.
Pholcodine may be tested according to a variety of international standards, such as European Pharmacopoeia (Pholcodine EP), Pholcodine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pholcodine USP).
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