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PharmaCompass offers a list of Desflurane 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 Desflurane manufacturer or Desflurane supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Desflurane manufacturer or Desflurane supplier.
PharmaCompass also assists you with knowing the Desflurane API Price utilized in the formulation of products. Desflurane API Price is not always fixed or binding as the Desflurane Price is obtained through a variety of data sources. The Desflurane Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Desflurane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Desflurane, including repackagers and relabelers. The FDA regulates Desflurane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Desflurane 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 Desflurane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Desflurane supplier is an individual or a company that provides Desflurane active pharmaceutical ingredient (API) or Desflurane finished formulations upon request. The Desflurane suppliers may include Desflurane API manufacturers, exporters, distributors and traders.
click here to find a list of Desflurane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Desflurane DMF (Drug Master File) is a document detailing the whole manufacturing process of Desflurane active pharmaceutical ingredient (API) in detail. Different forms of Desflurane DMFs exist exist since differing nations have different regulations, such as Desflurane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Desflurane DMF submitted to regulatory agencies in the US is known as a USDMF. Desflurane USDMF includes data on Desflurane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Desflurane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Desflurane suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Desflurane Drug Master File in Japan (Desflurane JDMF) empowers Desflurane API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Desflurane JDMF during the approval evaluation for pharmaceutical products. At the time of Desflurane JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Desflurane suppliers with JDMF 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 Desflurane Drug Master File in Korea (Desflurane KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Desflurane. The MFDS reviews the Desflurane KDMF as part of the drug registration process and uses the information provided in the Desflurane KDMF to evaluate the safety and efficacy of the drug.
After submitting a Desflurane 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 Desflurane API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Desflurane suppliers with KDMF on PharmaCompass.
Desflurane 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 Desflurane 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 Desflurane GMP manufacturer or Desflurane GMP API supplier for your needs.
A Desflurane CoA (Certificate of Analysis) is a formal document that attests to Desflurane's compliance with Desflurane specifications and serves as a tool for batch-level quality control.
Desflurane CoA mostly includes findings from lab analyses of a specific batch. For each Desflurane 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.
Desflurane may be tested according to a variety of international standards, such as European Pharmacopoeia (Desflurane EP), Desflurane JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Desflurane USP).