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