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PharmaCompass offers a list of Sodium Chloride 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 Sodium Chloride manufacturer or Sodium Chloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Chloride manufacturer or Sodium Chloride supplier.
PharmaCompass also assists you with knowing the Sodium Chloride API Price utilized in the formulation of products. Sodium Chloride API Price is not always fixed or binding as the Sodium Chloride Price is obtained through a variety of data sources. The Sodium Chloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sodium Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Chloride, including repackagers and relabelers. The FDA regulates Sodium Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Chloride 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 Sodium Chloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Chloride supplier is an individual or a company that provides Sodium Chloride active pharmaceutical ingredient (API) or Sodium Chloride finished formulations upon request. The Sodium Chloride suppliers may include Sodium Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Chloride active pharmaceutical ingredient (API) in detail. Different forms of Sodium Chloride DMFs exist exist since differing nations have different regulations, such as Sodium Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Chloride USDMF includes data on Sodium Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Chloride 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 Sodium Chloride Drug Master File in Japan (Sodium Chloride JDMF) empowers Sodium Chloride 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 Sodium Chloride JDMF during the approval evaluation for pharmaceutical products. At the time of Sodium Chloride 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 Sodium Chloride suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Sodium Chloride Drug Master File in Korea (Sodium Chloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sodium Chloride. The MFDS reviews the Sodium Chloride KDMF as part of the drug registration process and uses the information provided in the Sodium Chloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sodium Chloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Sodium Chloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sodium Chloride suppliers with KDMF on PharmaCompass.
A Sodium Chloride CEP of the European Pharmacopoeia monograph is often referred to as a Sodium Chloride Certificate of Suitability (COS). The purpose of a Sodium Chloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium Chloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium Chloride to their clients by showing that a Sodium Chloride CEP has been issued for it. The manufacturer submits a Sodium Chloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium Chloride CEP holder for the record. Additionally, the data presented in the Sodium Chloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium Chloride DMF.
A Sodium Chloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium Chloride 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 Sodium Chloride suppliers with CEP (COS) on PharmaCompass.
A Sodium Chloride written confirmation (Sodium Chloride WC) is an official document issued by a regulatory agency to a Sodium Chloride manufacturer, verifying that the manufacturing facility of a Sodium Chloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sodium Chloride APIs or Sodium Chloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Sodium Chloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Sodium Chloride 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 Sodium Chloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium Chloride 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 Sodium Chloride 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 Sodium Chloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium Chloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium Chloride suppliers with NDC on PharmaCompass.
Sodium Chloride 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 Sodium Chloride 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 Sodium Chloride GMP manufacturer or Sodium Chloride GMP API supplier for your needs.
A Sodium Chloride CoA (Certificate of Analysis) is a formal document that attests to Sodium Chloride's compliance with Sodium Chloride specifications and serves as a tool for batch-level quality control.
Sodium Chloride CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Chloride 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.
Sodium Chloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Chloride EP), Sodium Chloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Chloride USP).
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