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