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