01 1Aesica Queenborough Limited
02 2Lunan Pharmaceutical
03 1Piramal Enterprises Limited
04 2Blank
01 4ISOFLURANE
02 1ISOFLURANE (NON-STERILE BULK)
03 1ISOFLURANE USP
01 2China
02 1India
03 1United Kingdom
04 2Blank
01 4Active
02 2Inactive
01 2Complete
02 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9087
Submission : 1991-04-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-02-24
Pay. Date : 2021-01-11
DMF Number : 35361
Submission : 2020-12-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18995
Submission : 2005-11-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-30
Pay. Date : 2013-01-04
DMF Number : 9791
Submission : 1992-07-22
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12045
Submission : 1996-07-15
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10363
Submission : 1993-07-19
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Isoflurane manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoflurane, including repackagers and relabelers. The FDA regulates Isoflurane manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoflurane 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 Isoflurane manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isoflurane supplier is an individual or a company that provides Isoflurane active pharmaceutical ingredient (API) or Isoflurane finished formulations upon request. The Isoflurane suppliers may include Isoflurane API manufacturers, exporters, distributors and traders.
click here to find a list of Isoflurane suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isoflurane DMF (Drug Master File) is a document detailing the whole manufacturing process of Isoflurane active pharmaceutical ingredient (API) in detail. Different forms of Isoflurane DMFs exist exist since differing nations have different regulations, such as Isoflurane USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isoflurane DMF submitted to regulatory agencies in the US is known as a USDMF. Isoflurane USDMF includes data on Isoflurane's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isoflurane USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isoflurane suppliers with USDMF on PharmaCompass.
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