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ABOUT THIS PAGE
A Benserazide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benserazide, including repackagers and relabelers. The FDA regulates Benserazide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benserazide 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 Benserazide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benserazide supplier is an individual or a company that provides Benserazide active pharmaceutical ingredient (API) or Benserazide finished formulations upon request. The Benserazide suppliers may include Benserazide API manufacturers, exporters, distributors and traders.
click here to find a list of Benserazide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benserazide DMF (Drug Master File) is a document detailing the whole manufacturing process of Benserazide active pharmaceutical ingredient (API) in detail. Different forms of Benserazide DMFs exist exist since differing nations have different regulations, such as Benserazide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benserazide DMF submitted to regulatory agencies in the US is known as a USDMF. Benserazide USDMF includes data on Benserazide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benserazide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benserazide 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 Benserazide Drug Master File in Korea (Benserazide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Benserazide. The MFDS reviews the Benserazide KDMF as part of the drug registration process and uses the information provided in the Benserazide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Benserazide 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 Benserazide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Benserazide suppliers with KDMF on PharmaCompass.
A Benserazide CEP of the European Pharmacopoeia monograph is often referred to as a Benserazide Certificate of Suitability (COS). The purpose of a Benserazide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Benserazide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Benserazide to their clients by showing that a Benserazide CEP has been issued for it. The manufacturer submits a Benserazide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Benserazide CEP holder for the record. Additionally, the data presented in the Benserazide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Benserazide DMF.
A Benserazide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Benserazide 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 Benserazide suppliers with CEP (COS) on PharmaCompass.
A Benserazide written confirmation (Benserazide WC) is an official document issued by a regulatory agency to a Benserazide manufacturer, verifying that the manufacturing facility of a Benserazide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Benserazide APIs or Benserazide finished pharmaceutical products to another nation, regulatory agencies frequently require a Benserazide WC (written confirmation) as part of the regulatory process.
click here to find a list of Benserazide suppliers with Written Confirmation (WC) on PharmaCompass.
Benserazide 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 Benserazide 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 Benserazide GMP manufacturer or Benserazide GMP API supplier for your needs.
A Benserazide CoA (Certificate of Analysis) is a formal document that attests to Benserazide's compliance with Benserazide specifications and serves as a tool for batch-level quality control.
Benserazide CoA mostly includes findings from lab analyses of a specific batch. For each Benserazide 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.
Benserazide may be tested according to a variety of international standards, such as European Pharmacopoeia (Benserazide EP), Benserazide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Benserazide USP).
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