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