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Rochem International Inc
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
38
PharmaCompass offers a list of Rifampicin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Rifampicin manufacturer or Rifampicin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rifampicin manufacturer or Rifampicin supplier.
A Riforal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Riforal, including repackagers and relabelers. The FDA regulates Riforal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Riforal 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 Riforal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Riforal supplier is an individual or a company that provides Riforal active pharmaceutical ingredient (API) or Riforal finished formulations upon request. The Riforal suppliers may include Riforal API manufacturers, exporters, distributors and traders.
click here to find a list of Riforal suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Riforal DMF (Drug Master File) is a document detailing the whole manufacturing process of Riforal active pharmaceutical ingredient (API) in detail. Different forms of Riforal DMFs exist exist since differing nations have different regulations, such as Riforal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Riforal DMF submitted to regulatory agencies in the US is known as a USDMF. Riforal USDMF includes data on Riforal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Riforal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Riforal 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 Riforal Drug Master File in Japan (Riforal JDMF) empowers Riforal 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 Riforal JDMF during the approval evaluation for pharmaceutical products. At the time of Riforal 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 Riforal 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 Riforal Drug Master File in Korea (Riforal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Riforal. The MFDS reviews the Riforal KDMF as part of the drug registration process and uses the information provided in the Riforal KDMF to evaluate the safety and efficacy of the drug.
After submitting a Riforal 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 Riforal API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Riforal suppliers with KDMF on PharmaCompass.
A Riforal CEP of the European Pharmacopoeia monograph is often referred to as a Riforal Certificate of Suitability (COS). The purpose of a Riforal CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Riforal EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Riforal to their clients by showing that a Riforal CEP has been issued for it. The manufacturer submits a Riforal CEP (COS) as part of the market authorization procedure, and it takes on the role of a Riforal CEP holder for the record. Additionally, the data presented in the Riforal CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Riforal DMF.
A Riforal CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Riforal 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 Riforal suppliers with CEP (COS) on PharmaCompass.
A Riforal written confirmation (Riforal WC) is an official document issued by a regulatory agency to a Riforal manufacturer, verifying that the manufacturing facility of a Riforal active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Riforal APIs or Riforal finished pharmaceutical products to another nation, regulatory agencies frequently require a Riforal WC (written confirmation) as part of the regulatory process.
click here to find a list of Riforal 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 Riforal as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Riforal 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 Riforal 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 Riforal and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Riforal NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Riforal suppliers with NDC on PharmaCompass.
Riforal 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 Riforal GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Riforal GMP manufacturer or Riforal GMP API supplier for your needs.
A Riforal CoA (Certificate of Analysis) is a formal document that attests to Riforal's compliance with Riforal specifications and serves as a tool for batch-level quality control.
Riforal CoA mostly includes findings from lab analyses of a specific batch. For each Riforal 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.
Riforal may be tested according to a variety of international standards, such as European Pharmacopoeia (Riforal EP), Riforal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Riforal USP).
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