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API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Huzhou Sunflower Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
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REF. STANDARDS & IMPURITIES
USP
ABOUT THIS PAGE
A Bismuth Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bismuth Nitrate, including repackagers and relabelers. The FDA regulates Bismuth Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bismuth Nitrate 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 Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bismuth Nitrate supplier is an individual or a company that provides Bismuth Nitrate active pharmaceutical ingredient (API) or Bismuth Nitrate finished formulations upon request. The Bismuth Nitrate suppliers may include Bismuth Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Bismuth Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bismuth Nitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Bismuth Nitrate active pharmaceutical ingredient (API) in detail. Different forms of Bismuth Nitrate DMFs exist exist since differing nations have different regulations, such as Bismuth Nitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bismuth Nitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Bismuth Nitrate USDMF includes data on Bismuth Nitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bismuth Nitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bismuth Nitrate 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 Bismuth Nitrate Drug Master File in Japan (Bismuth Nitrate JDMF) empowers Bismuth Nitrate 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 Bismuth Nitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Bismuth Nitrate 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 Bismuth Nitrate suppliers with JDMF 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 Nitrate Drug Master File in Korea (Bismuth Nitrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bismuth Nitrate. The MFDS reviews the Bismuth Nitrate KDMF as part of the drug registration process and uses the information provided in the Bismuth Nitrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bismuth Nitrate 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 Nitrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bismuth Nitrate suppliers with KDMF on PharmaCompass.
A Bismuth Nitrate CEP of the European Pharmacopoeia monograph is often referred to as a Bismuth Nitrate Certificate of Suitability (COS). The purpose of a Bismuth Nitrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bismuth Nitrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bismuth Nitrate to their clients by showing that a Bismuth Nitrate CEP has been issued for it. The manufacturer submits a Bismuth Nitrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bismuth Nitrate CEP holder for the record. Additionally, the data presented in the Bismuth Nitrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bismuth Nitrate DMF.
A Bismuth Nitrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bismuth Nitrate 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 Bismuth Nitrate 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 Bismuth Nitrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bismuth Nitrate 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 Nitrate 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 Nitrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bismuth Nitrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bismuth Nitrate suppliers with NDC on PharmaCompass.
Bismuth Nitrate 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 Nitrate 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 Nitrate GMP manufacturer or Bismuth Nitrate GMP API supplier for your needs.
A Bismuth Nitrate CoA (Certificate of Analysis) is a formal document that attests to Bismuth Nitrate's compliance with Bismuth Nitrate specifications and serves as a tool for batch-level quality control.
Bismuth Nitrate CoA mostly includes findings from lab analyses of a specific batch. For each Bismuth Nitrate 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 Nitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Bismuth Nitrate EP), Bismuth Nitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bismuth Nitrate USP).
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