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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Rifabutin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rifabutin, including repackagers and relabelers. The FDA regulates Rifabutin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rifabutin 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 Rifabutin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rifabutin supplier is an individual or a company that provides Rifabutin active pharmaceutical ingredient (API) or Rifabutin finished formulations upon request. The Rifabutin suppliers may include Rifabutin API manufacturers, exporters, distributors and traders.
click here to find a list of Rifabutin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rifabutin DMF (Drug Master File) is a document detailing the whole manufacturing process of Rifabutin active pharmaceutical ingredient (API) in detail. Different forms of Rifabutin DMFs exist exist since differing nations have different regulations, such as Rifabutin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rifabutin DMF submitted to regulatory agencies in the US is known as a USDMF. Rifabutin USDMF includes data on Rifabutin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rifabutin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rifabutin suppliers with USDMF on PharmaCompass.
A Rifabutin CEP of the European Pharmacopoeia monograph is often referred to as a Rifabutin Certificate of Suitability (COS). The purpose of a Rifabutin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rifabutin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rifabutin to their clients by showing that a Rifabutin CEP has been issued for it. The manufacturer submits a Rifabutin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rifabutin CEP holder for the record. Additionally, the data presented in the Rifabutin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rifabutin DMF.
A Rifabutin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rifabutin 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 Rifabutin suppliers with CEP (COS) on PharmaCompass.
A Rifabutin written confirmation (Rifabutin WC) is an official document issued by a regulatory agency to a Rifabutin manufacturer, verifying that the manufacturing facility of a Rifabutin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rifabutin APIs or Rifabutin finished pharmaceutical products to another nation, regulatory agencies frequently require a Rifabutin WC (written confirmation) as part of the regulatory process.
click here to find a list of Rifabutin 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 Rifabutin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rifabutin 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 Rifabutin 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 Rifabutin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rifabutin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rifabutin suppliers with NDC on PharmaCompass.
Rifabutin 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 Rifabutin 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 Rifabutin GMP manufacturer or Rifabutin GMP API supplier for your needs.
A Rifabutin CoA (Certificate of Analysis) is a formal document that attests to Rifabutin's compliance with Rifabutin specifications and serves as a tool for batch-level quality control.
Rifabutin CoA mostly includes findings from lab analyses of a specific batch. For each Rifabutin 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.
Rifabutin may be tested according to a variety of international standards, such as European Pharmacopoeia (Rifabutin EP), Rifabutin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rifabutin USP).
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