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