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PharmaCompass offers a list of Sodium Acetate 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 Acetate manufacturer or Sodium Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Acetate manufacturer or Sodium Acetate supplier.
PharmaCompass also assists you with knowing the Sodium Acetate API Price utilized in the formulation of products. Sodium Acetate API Price is not always fixed or binding as the Sodium Acetate Price is obtained through a variety of data sources. The Sodium Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sodium Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Acetate, including repackagers and relabelers. The FDA regulates Sodium Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Acetate 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 Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Acetate supplier is an individual or a company that provides Sodium Acetate active pharmaceutical ingredient (API) or Sodium Acetate finished formulations upon request. The Sodium Acetate suppliers may include Sodium Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Acetate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Acetate DMFs exist exist since differing nations have different regulations, such as Sodium Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Acetate USDMF includes data on Sodium Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Acetate 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 Acetate Drug Master File in Japan (Sodium Acetate JDMF) empowers Sodium Acetate 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 Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Sodium Acetate 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 Acetate suppliers with JDMF 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 Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium Acetate 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 Acetate 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 Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium Acetate suppliers with NDC on PharmaCompass.
Sodium Acetate 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 Acetate 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 Acetate GMP manufacturer or Sodium Acetate GMP API supplier for your needs.
A Sodium Acetate CoA (Certificate of Analysis) is a formal document that attests to Sodium Acetate's compliance with Sodium Acetate specifications and serves as a tool for batch-level quality control.
Sodium Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Acetate 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 Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Acetate EP), Sodium Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Acetate USP).