01 1Blue-Zone Technologies
02 1Central Glass Europe
03 2Jiangsu Hengrui Medicine
04 2Lunan Pharmaceutical
01 1SEVOFLURANE
02 1SEVOFLURANE (NON-STERILE BULK FORM)
03 3SEVOFLURANE USP
04 1SEVOFLURANE USP, NON-STERILE, BULK DRUG SUBSTANCE
01 1Canada
02 4China
03 1United Kingdom
01 4Active
02 2Inactive
01 2Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38857
Submission : 2023-10-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11132
Submission : 1994-10-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-11-04
Pay. Date : 2016-08-15
DMF Number : 30570
Submission : 2016-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24903
Submission : 2011-04-29
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-12-09
Pay. Date : 2019-09-27
DMF Number : 22740
Submission : 2009-04-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19091
Submission : 2005-12-20
Status : Inactive
Type : II
A Sevoflurane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sevoflurane, including repackagers and relabelers. The FDA regulates Sevoflurane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sevoflurane 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 Sevoflurane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sevoflurane supplier is an individual or a company that provides Sevoflurane active pharmaceutical ingredient (API) or Sevoflurane finished formulations upon request. The Sevoflurane suppliers may include Sevoflurane API manufacturers, exporters, distributors and traders.
click here to find a list of Sevoflurane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sevoflurane DMF (Drug Master File) is a document detailing the whole manufacturing process of Sevoflurane active pharmaceutical ingredient (API) in detail. Different forms of Sevoflurane DMFs exist exist since differing nations have different regulations, such as Sevoflurane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sevoflurane DMF submitted to regulatory agencies in the US is known as a USDMF. Sevoflurane USDMF includes data on Sevoflurane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sevoflurane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sevoflurane suppliers with USDMF on PharmaCompass.
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