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