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