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JDMF
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South Africa
DRUG PRODUCT COMPOSITIONS
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API SUPPLIERS
AMI Lifesciences is Driven by Chemistry. Powered by People.
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC 
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
Maithri Drugs: Dedicated to your API needs.
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
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USDMF
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EUROAPI
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Brivaracetam 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 Brivaracetam manufacturer or Brivaracetam supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Brivaracetam manufacturer or Brivaracetam supplier.
PharmaCompass also assists you with knowing the Brivaracetam API Price utilized in the formulation of products. Brivaracetam API Price is not always fixed or binding as the Brivaracetam Price is obtained through a variety of data sources. The Brivaracetam Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Briviact manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Briviact, including repackagers and relabelers. The FDA regulates Briviact manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Briviact 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 Briviact manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Briviact supplier is an individual or a company that provides Briviact active pharmaceutical ingredient (API) or Briviact finished formulations upon request. The Briviact suppliers may include Briviact API manufacturers, exporters, distributors and traders.
click here to find a list of Briviact suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Briviact DMF (Drug Master File) is a document detailing the whole manufacturing process of Briviact active pharmaceutical ingredient (API) in detail. Different forms of Briviact DMFs exist exist since differing nations have different regulations, such as Briviact USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Briviact DMF submitted to regulatory agencies in the US is known as a USDMF. Briviact USDMF includes data on Briviact's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Briviact USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Briviact 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 Briviact Drug Master File in Korea (Briviact KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Briviact. The MFDS reviews the Briviact KDMF as part of the drug registration process and uses the information provided in the Briviact KDMF to evaluate the safety and efficacy of the drug.
After submitting a Briviact 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 Briviact API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Briviact suppliers with KDMF on PharmaCompass.
A Briviact CEP of the European Pharmacopoeia monograph is often referred to as a Briviact Certificate of Suitability (COS). The purpose of a Briviact CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Briviact EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Briviact to their clients by showing that a Briviact CEP has been issued for it. The manufacturer submits a Briviact CEP (COS) as part of the market authorization procedure, and it takes on the role of a Briviact CEP holder for the record. Additionally, the data presented in the Briviact CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Briviact DMF.
A Briviact CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Briviact 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 Briviact suppliers with CEP (COS) on PharmaCompass.
A Briviact written confirmation (Briviact WC) is an official document issued by a regulatory agency to a Briviact manufacturer, verifying that the manufacturing facility of a Briviact active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Briviact APIs or Briviact finished pharmaceutical products to another nation, regulatory agencies frequently require a Briviact WC (written confirmation) as part of the regulatory process.
click here to find a list of Briviact 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 Briviact as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Briviact 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 Briviact 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 Briviact and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Briviact NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Briviact suppliers with NDC on PharmaCompass.
Briviact 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 Briviact 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 Briviact GMP manufacturer or Briviact GMP API supplier for your needs.
A Briviact CoA (Certificate of Analysis) is a formal document that attests to Briviact's compliance with Briviact specifications and serves as a tool for batch-level quality control.
Briviact CoA mostly includes findings from lab analyses of a specific batch. For each Briviact 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.
Briviact may be tested according to a variety of international standards, such as European Pharmacopoeia (Briviact EP), Briviact JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Briviact USP).
