US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Povidone-Iodine 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 Povidone-Iodine manufacturer or Povidone-Iodine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Povidone-Iodine manufacturer or Povidone-Iodine supplier.
PharmaCompass also assists you with knowing the Povidone-Iodine API Price utilized in the formulation of products. Povidone-Iodine API Price is not always fixed or binding as the Povidone-Iodine Price is obtained through a variety of data sources. The Povidone-Iodine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Povidone Iodine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Povidone Iodine, including repackagers and relabelers. The FDA regulates Povidone Iodine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Povidone Iodine 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 Povidone Iodine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Povidone Iodine supplier is an individual or a company that provides Povidone Iodine active pharmaceutical ingredient (API) or Povidone Iodine finished formulations upon request. The Povidone Iodine suppliers may include Povidone Iodine API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Povidone Iodine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Povidone Iodine DMF (Drug Master File) is a document detailing the whole manufacturing process of Povidone Iodine active pharmaceutical ingredient (API) in detail. Different forms of Povidone Iodine DMFs exist exist since differing nations have different regulations, such as Povidone Iodine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Povidone Iodine DMF submitted to regulatory agencies in the US is known as a USDMF. Povidone Iodine USDMF includes data on Povidone Iodine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Povidone Iodine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Povidone Iodine Drug Master File in Japan (Povidone Iodine JDMF) empowers Povidone Iodine 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 Povidone Iodine JDMF during the approval evaluation for pharmaceutical products. At the time of Povidone Iodine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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A Povidone Iodine CEP of the European Pharmacopoeia monograph is often referred to as a Povidone Iodine Certificate of Suitability (COS). The purpose of a Povidone Iodine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Povidone Iodine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Povidone Iodine to their clients by showing that a Povidone Iodine CEP has been issued for it. The manufacturer submits a Povidone Iodine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Povidone Iodine CEP holder for the record. Additionally, the data presented in the Povidone Iodine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Povidone Iodine DMF.
A Povidone Iodine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Povidone Iodine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Povidone Iodine written confirmation (Povidone Iodine WC) is an official document issued by a regulatory agency to a Povidone Iodine manufacturer, verifying that the manufacturing facility of a Povidone Iodine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Povidone Iodine APIs or Povidone Iodine finished pharmaceutical products to another nation, regulatory agencies frequently require a Povidone Iodine WC (written confirmation) as part of the regulatory process.
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National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Povidone Iodine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Povidone Iodine API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Povidone Iodine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Povidone Iodine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Povidone Iodine NDC to their finished compounded human drug products, they may choose to do so.
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Povidone Iodine 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 Povidone Iodine 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 Povidone Iodine GMP manufacturer or Povidone Iodine GMP API supplier for your needs.
A Povidone Iodine CoA (Certificate of Analysis) is a formal document that attests to Povidone Iodine's compliance with Povidone Iodine specifications and serves as a tool for batch-level quality control.
Povidone Iodine CoA mostly includes findings from lab analyses of a specific batch. For each Povidone Iodine 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.
Povidone Iodine may be tested according to a variety of international standards, such as European Pharmacopoeia (Povidone Iodine EP), Povidone Iodine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Povidone Iodine USP).