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PharmaCompass offers a list of Bismuth 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 Bismuth manufacturer or Bismuth supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bismuth manufacturer or Bismuth supplier.
PharmaCompass also assists you with knowing the Bismuth API Price utilized in the formulation of products. Bismuth API Price is not always fixed or binding as the Bismuth Price is obtained through a variety of data sources. The Bismuth Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bismuth manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bismuth, including repackagers and relabelers. The FDA regulates Bismuth manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bismuth API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Bismuth supplier is an individual or a company that provides Bismuth active pharmaceutical ingredient (API) or Bismuth finished formulations upon request. The Bismuth suppliers may include Bismuth API manufacturers, exporters, distributors and traders.
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 Bismuth as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bismuth 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 Bismuth 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 Bismuth and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bismuth NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bismuth suppliers with NDC on PharmaCompass.
Bismuth 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 Bismuth 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 Bismuth GMP manufacturer or Bismuth GMP API supplier for your needs.
A Bismuth CoA (Certificate of Analysis) is a formal document that attests to Bismuth's compliance with Bismuth specifications and serves as a tool for batch-level quality control.
Bismuth CoA mostly includes findings from lab analyses of a specific batch. For each Bismuth 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.
Bismuth may be tested according to a variety of international standards, such as European Pharmacopoeia (Bismuth EP), Bismuth JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bismuth USP).
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