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