API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
USA (Orange Book)
Europe
0
Canada
Australia
0
South Africa
0
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
92
PharmaCompass offers a list of Bismuth Subsalicylate 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 Subsalicylate manufacturer or Bismuth Subsalicylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bismuth Subsalicylate manufacturer or Bismuth Subsalicylate supplier.
PharmaCompass also assists you with knowing the Bismuth Subsalicylate API Price utilized in the formulation of products. Bismuth Subsalicylate API Price is not always fixed or binding as the Bismuth Subsalicylate Price is obtained through a variety of data sources. The Bismuth Subsalicylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bismuth Subsalicylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bismuth Subsalicylate, including repackagers and relabelers. The FDA regulates Bismuth Subsalicylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bismuth Subsalicylate 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 Bismuth Subsalicylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bismuth Subsalicylate supplier is an individual or a company that provides Bismuth Subsalicylate active pharmaceutical ingredient (API) or Bismuth Subsalicylate finished formulations upon request. The Bismuth Subsalicylate suppliers may include Bismuth Subsalicylate API manufacturers, exporters, distributors and traders.
click here to find a list of Bismuth Subsalicylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bismuth Subsalicylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Bismuth Subsalicylate active pharmaceutical ingredient (API) in detail. Different forms of Bismuth Subsalicylate DMFs exist exist since differing nations have different regulations, such as Bismuth Subsalicylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bismuth Subsalicylate DMF submitted to regulatory agencies in the US is known as a USDMF. Bismuth Subsalicylate USDMF includes data on Bismuth Subsalicylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bismuth Subsalicylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bismuth Subsalicylate suppliers with USDMF 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 Bismuth Subsalicylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bismuth Subsalicylate 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 Subsalicylate 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 Subsalicylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bismuth Subsalicylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bismuth Subsalicylate suppliers with NDC on PharmaCompass.
Bismuth Subsalicylate 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 Subsalicylate 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 Subsalicylate GMP manufacturer or Bismuth Subsalicylate GMP API supplier for your needs.
A Bismuth Subsalicylate CoA (Certificate of Analysis) is a formal document that attests to Bismuth Subsalicylate's compliance with Bismuth Subsalicylate specifications and serves as a tool for batch-level quality control.
Bismuth Subsalicylate CoA mostly includes findings from lab analyses of a specific batch. For each Bismuth Subsalicylate 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 Subsalicylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Bismuth Subsalicylate EP), Bismuth Subsalicylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bismuth Subsalicylate USP).