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DOSAGE - INJECTABLE;INJECTION - 0.5MG/5ML (0....DOSAGE - INJECTABLE;INJECTION - 0.5MG/5ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20073
DOSAGE - INJECTABLE;INJECTION - 1MG/10ML (0.1...DOSAGE - INJECTABLE;INJECTION - 1MG/10ML (0.1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20073
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ABOUT THIS PAGE
A Flumazenil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flumazenil, including repackagers and relabelers. The FDA regulates Flumazenil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flumazenil 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 Flumazenil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flumazenil supplier is an individual or a company that provides Flumazenil active pharmaceutical ingredient (API) or Flumazenil finished formulations upon request. The Flumazenil suppliers may include Flumazenil API manufacturers, exporters, distributors and traders.
click here to find a list of Flumazenil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Flumazenil DMF (Drug Master File) is a document detailing the whole manufacturing process of Flumazenil active pharmaceutical ingredient (API) in detail. Different forms of Flumazenil DMFs exist exist since differing nations have different regulations, such as Flumazenil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flumazenil DMF submitted to regulatory agencies in the US is known as a USDMF. Flumazenil USDMF includes data on Flumazenil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flumazenil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Flumazenil 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 Flumazenil Drug Master File in Japan (Flumazenil JDMF) empowers Flumazenil 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 Flumazenil JDMF during the approval evaluation for pharmaceutical products. At the time of Flumazenil 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 Flumazenil 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 Flumazenil Drug Master File in Korea (Flumazenil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Flumazenil. The MFDS reviews the Flumazenil KDMF as part of the drug registration process and uses the information provided in the Flumazenil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Flumazenil 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 Flumazenil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Flumazenil suppliers with KDMF on PharmaCompass.
A Flumazenil CEP of the European Pharmacopoeia monograph is often referred to as a Flumazenil Certificate of Suitability (COS). The purpose of a Flumazenil CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Flumazenil EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Flumazenil to their clients by showing that a Flumazenil CEP has been issued for it. The manufacturer submits a Flumazenil CEP (COS) as part of the market authorization procedure, and it takes on the role of a Flumazenil CEP holder for the record. Additionally, the data presented in the Flumazenil CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Flumazenil DMF.
A Flumazenil CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Flumazenil 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 Flumazenil 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 Flumazenil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Flumazenil 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 Flumazenil 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 Flumazenil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Flumazenil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Flumazenil suppliers with NDC on PharmaCompass.
Flumazenil 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 Flumazenil 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 Flumazenil GMP manufacturer or Flumazenil GMP API supplier for your needs.
A Flumazenil CoA (Certificate of Analysis) is a formal document that attests to Flumazenil's compliance with Flumazenil specifications and serves as a tool for batch-level quality control.
Flumazenil CoA mostly includes findings from lab analyses of a specific batch. For each Flumazenil 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.
Flumazenil may be tested according to a variety of international standards, such as European Pharmacopoeia (Flumazenil EP), Flumazenil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Flumazenil USP).
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