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