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PharmaCompass offers a list of Perfluorobutane 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 Perfluorobutane manufacturer or Perfluorobutane supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Perfluorobutane manufacturer or Perfluorobutane supplier.
PharmaCompass also assists you with knowing the Perfluorobutane API Price utilized in the formulation of products. Perfluorobutane API Price is not always fixed or binding as the Perfluorobutane Price is obtained through a variety of data sources. The Perfluorobutane Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Perfluorobutane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perfluorobutane, including repackagers and relabelers. The FDA regulates Perfluorobutane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perfluorobutane API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Perfluorobutane supplier is an individual or a company that provides Perfluorobutane active pharmaceutical ingredient (API) or Perfluorobutane finished formulations upon request. The Perfluorobutane suppliers may include Perfluorobutane API manufacturers, exporters, distributors and traders.
click here to find a list of Perfluorobutane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Perfluorobutane DMF (Drug Master File) is a document detailing the whole manufacturing process of Perfluorobutane active pharmaceutical ingredient (API) in detail. Different forms of Perfluorobutane DMFs exist exist since differing nations have different regulations, such as Perfluorobutane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Perfluorobutane DMF submitted to regulatory agencies in the US is known as a USDMF. Perfluorobutane USDMF includes data on Perfluorobutane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Perfluorobutane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Perfluorobutane 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 Perfluorobutane Drug Master File in Korea (Perfluorobutane KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Perfluorobutane. The MFDS reviews the Perfluorobutane KDMF as part of the drug registration process and uses the information provided in the Perfluorobutane KDMF to evaluate the safety and efficacy of the drug.
After submitting a Perfluorobutane 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 Perfluorobutane API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Perfluorobutane suppliers with KDMF on PharmaCompass.
Perfluorobutane 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 Perfluorobutane 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 Perfluorobutane GMP manufacturer or Perfluorobutane GMP API supplier for your needs.
A Perfluorobutane CoA (Certificate of Analysis) is a formal document that attests to Perfluorobutane's compliance with Perfluorobutane specifications and serves as a tool for batch-level quality control.
Perfluorobutane CoA mostly includes findings from lab analyses of a specific batch. For each Perfluorobutane 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.
Perfluorobutane may be tested according to a variety of international standards, such as European Pharmacopoeia (Perfluorobutane EP), Perfluorobutane JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Perfluorobutane USP).
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