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USDMF
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36655
Submission : 2022-01-08
Status :
Type : II
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AMI Lifesciences is Driven by Chemistry. Powered by People.
Date of Issue : 2022-08-11
Valid Till : 2025-06-26
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post. Karakhadi, Tal-Padra, City Karakhadi -39145...
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ABOUT THIS PAGE
A Brivaracetam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brivaracetam, including repackagers and relabelers. The FDA regulates Brivaracetam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brivaracetam 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 Brivaracetam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Brivaracetam supplier is an individual or a company that provides Brivaracetam active pharmaceutical ingredient (API) or Brivaracetam finished formulations upon request. The Brivaracetam suppliers may include Brivaracetam API manufacturers, exporters, distributors and traders.
click here to find a list of Brivaracetam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Brivaracetam DMF (Drug Master File) is a document detailing the whole manufacturing process of Brivaracetam active pharmaceutical ingredient (API) in detail. Different forms of Brivaracetam DMFs exist exist since differing nations have different regulations, such as Brivaracetam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Brivaracetam DMF submitted to regulatory agencies in the US is known as a USDMF. Brivaracetam USDMF includes data on Brivaracetam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Brivaracetam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Brivaracetam suppliers with USDMF 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 Brivaracetam Drug Master File in Korea (Brivaracetam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Brivaracetam. The MFDS reviews the Brivaracetam KDMF as part of the drug registration process and uses the information provided in the Brivaracetam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Brivaracetam 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 Brivaracetam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Brivaracetam suppliers with KDMF on PharmaCompass.
A Brivaracetam CEP of the European Pharmacopoeia monograph is often referred to as a Brivaracetam Certificate of Suitability (COS). The purpose of a Brivaracetam CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Brivaracetam EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Brivaracetam to their clients by showing that a Brivaracetam CEP has been issued for it. The manufacturer submits a Brivaracetam CEP (COS) as part of the market authorization procedure, and it takes on the role of a Brivaracetam CEP holder for the record. Additionally, the data presented in the Brivaracetam CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Brivaracetam DMF.
A Brivaracetam CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Brivaracetam 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 Brivaracetam suppliers with CEP (COS) on PharmaCompass.
A Brivaracetam written confirmation (Brivaracetam WC) is an official document issued by a regulatory agency to a Brivaracetam manufacturer, verifying that the manufacturing facility of a Brivaracetam active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Brivaracetam APIs or Brivaracetam finished pharmaceutical products to another nation, regulatory agencies frequently require a Brivaracetam WC (written confirmation) as part of the regulatory process.
click here to find a list of Brivaracetam 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 Brivaracetam as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Brivaracetam 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 Brivaracetam 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 Brivaracetam and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Brivaracetam NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Brivaracetam suppliers with NDC on PharmaCompass.
Brivaracetam 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 Brivaracetam 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 Brivaracetam GMP manufacturer or Brivaracetam GMP API supplier for your needs.
A Brivaracetam CoA (Certificate of Analysis) is a formal document that attests to Brivaracetam's compliance with Brivaracetam specifications and serves as a tool for batch-level quality control.
Brivaracetam CoA mostly includes findings from lab analyses of a specific batch. For each Brivaracetam 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.
Brivaracetam may be tested according to a variety of international standards, such as European Pharmacopoeia (Brivaracetam EP), Brivaracetam JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Brivaracetam USP).
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