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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
About the Company : Established in 1990, Inabata France, a part of the Inabata Group, used to export chemical and pharmaceutical products to Japan. In 2006, it acquired Pharmasynthèse. Today, Inabata...
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PharmaCompass offers a list of Isoconazole Nitrate 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 Isoconazole Nitrate manufacturer or Isoconazole Nitrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Isoconazole Nitrate manufacturer or Isoconazole Nitrate supplier.
PharmaCompass also assists you with knowing the Isoconazole Nitrate API Price utilized in the formulation of products. Isoconazole Nitrate API Price is not always fixed or binding as the Isoconazole Nitrate Price is obtained through a variety of data sources. The Isoconazole Nitrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Isoconazole Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoconazole Nitrate, including repackagers and relabelers. The FDA regulates Isoconazole Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoconazole Nitrate 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 Isoconazole Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isoconazole Nitrate supplier is an individual or a company that provides Isoconazole Nitrate active pharmaceutical ingredient (API) or Isoconazole Nitrate finished formulations upon request. The Isoconazole Nitrate suppliers may include Isoconazole Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Isoconazole Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Isoconazole Nitrate Drug Master File in Japan (Isoconazole Nitrate JDMF) empowers Isoconazole Nitrate 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 Isoconazole Nitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Isoconazole Nitrate 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 Isoconazole Nitrate suppliers with JDMF on PharmaCompass.
A Isoconazole Nitrate CEP of the European Pharmacopoeia monograph is often referred to as a Isoconazole Nitrate Certificate of Suitability (COS). The purpose of a Isoconazole Nitrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Isoconazole Nitrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Isoconazole Nitrate to their clients by showing that a Isoconazole Nitrate CEP has been issued for it. The manufacturer submits a Isoconazole Nitrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Isoconazole Nitrate CEP holder for the record. Additionally, the data presented in the Isoconazole Nitrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Isoconazole Nitrate DMF.
A Isoconazole Nitrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Isoconazole Nitrate 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 Isoconazole Nitrate suppliers with CEP (COS) on PharmaCompass.
A Isoconazole Nitrate written confirmation (Isoconazole Nitrate WC) is an official document issued by a regulatory agency to a Isoconazole Nitrate manufacturer, verifying that the manufacturing facility of a Isoconazole Nitrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Isoconazole Nitrate APIs or Isoconazole Nitrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Isoconazole Nitrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Isoconazole Nitrate suppliers with Written Confirmation (WC) on PharmaCompass.
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 Isoconazole Nitrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Isoconazole Nitrate 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 Isoconazole Nitrate 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 Isoconazole Nitrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Isoconazole Nitrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Isoconazole Nitrate suppliers with NDC on PharmaCompass.
Isoconazole Nitrate 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 Isoconazole Nitrate 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 Isoconazole Nitrate GMP manufacturer or Isoconazole Nitrate GMP API supplier for your needs.
A Isoconazole Nitrate CoA (Certificate of Analysis) is a formal document that attests to Isoconazole Nitrate's compliance with Isoconazole Nitrate specifications and serves as a tool for batch-level quality control.
Isoconazole Nitrate CoA mostly includes findings from lab analyses of a specific batch. For each Isoconazole Nitrate 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.
Isoconazole Nitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Isoconazole Nitrate EP), Isoconazole Nitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Isoconazole Nitrate USP).
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