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ABOUT THIS PAGE
A Bismuth Potassium Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bismuth Potassium Citrate, including repackagers and relabelers. The FDA regulates Bismuth Potassium Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bismuth Potassium Citrate 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 Potassium Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bismuth Potassium Citrate supplier is an individual or a company that provides Bismuth Potassium Citrate active pharmaceutical ingredient (API) or Bismuth Potassium Citrate finished formulations upon request. The Bismuth Potassium Citrate suppliers may include Bismuth Potassium Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Bismuth Potassium Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bismuth Potassium Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Bismuth Potassium Citrate active pharmaceutical ingredient (API) in detail. Different forms of Bismuth Potassium Citrate DMFs exist exist since differing nations have different regulations, such as Bismuth Potassium Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bismuth Potassium Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Bismuth Potassium Citrate USDMF includes data on Bismuth Potassium Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bismuth Potassium Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bismuth Potassium Citrate suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Bismuth Potassium Citrate Drug Master File in Korea (Bismuth Potassium Citrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bismuth Potassium Citrate. The MFDS reviews the Bismuth Potassium Citrate KDMF as part of the drug registration process and uses the information provided in the Bismuth Potassium Citrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bismuth Potassium Citrate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Bismuth Potassium Citrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bismuth Potassium Citrate suppliers with KDMF on PharmaCompass.
Bismuth Potassium Citrate 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 Potassium Citrate 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 Potassium Citrate GMP manufacturer or Bismuth Potassium Citrate GMP API supplier for your needs.
A Bismuth Potassium Citrate CoA (Certificate of Analysis) is a formal document that attests to Bismuth Potassium Citrate's compliance with Bismuth Potassium Citrate specifications and serves as a tool for batch-level quality control.
Bismuth Potassium Citrate CoA mostly includes findings from lab analyses of a specific batch. For each Bismuth Potassium Citrate 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 Potassium Citrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Bismuth Potassium Citrate EP), Bismuth Potassium Citrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bismuth Potassium Citrate USP).
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