01 1Abbott Laboratories
02 4Basildon Chemicals
03 2NuSil Technology
04 5RioCare India
05 3The Dow Chemical Company
06 1Blank
01 1LIVEO Q7-2243 LVA, SIMETHICONE USP
02 1LIVEO™ Q7-2587 30% SIMETHICONE EMULSION USP
03 1LIVEO™7-9245 30% SIMETHICONE EMULSION USP AND LIVEO™ MEDICAL ANTIFOAM C EMULSION
04 1MED-340 SIMETHICONE USP /EP
05 1MED-342 SIMETHICONE GS
06 1SIMETHICONE 50% POWDER
07 1SIMETHICONE COATED CELLULOSE (SONORX); MANFACTURED IN NORTH CHICAGO, IL
08 2SIMETHICONE EMULSION USP
09 1SIMETHICONE EMULSION USP (BC SIMETHICONE ANTIFOAM PD30S)
10 2SIMETHICONE USP
11 1SIMETHICONE USP (BASIDON CHEMICALS SIMETHICONE ANTIFOAM C100LV)
12 1SIMETHICONE USP (BASILDON CHEMICALS SIMETHICONE AFC2-2671)
13 1SIMETHICONE USP (BASILDON CHEMICALS SIMETHICONE ANTIFOAM C100F)
14 1SIMETHICONE USP (BULK FORM)
01 5India
02 6U.S.A
03 4United Kingdom
04 1Blank
01 14Active
02 2Inactive
01 2Complete
02 14Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14035
Submission : 1999-03-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30430
Submission : 2016-05-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30349
Submission : 2016-03-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27490
Submission : 2015-01-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2012-12-05
DMF Number : 14322
Submission : 1999-07-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18689
Submission : 2005-08-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18687
Submission : 2005-08-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27561
Submission : 2013-11-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27556
Submission : 2013-11-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-14
Pay. Date : 2017-09-22
DMF Number : 1467
Submission : 1969-12-31
Status : Active
Type : II
A Simethicone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Simethicone, including repackagers and relabelers. The FDA regulates Simethicone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Simethicone 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 Simethicone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Simethicone supplier is an individual or a company that provides Simethicone active pharmaceutical ingredient (API) or Simethicone finished formulations upon request. The Simethicone suppliers may include Simethicone API manufacturers, exporters, distributors and traders.
click here to find a list of Simethicone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Simethicone DMF (Drug Master File) is a document detailing the whole manufacturing process of Simethicone active pharmaceutical ingredient (API) in detail. Different forms of Simethicone DMFs exist exist since differing nations have different regulations, such as Simethicone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Simethicone DMF submitted to regulatory agencies in the US is known as a USDMF. Simethicone USDMF includes data on Simethicone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Simethicone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Simethicone suppliers with USDMF on PharmaCompass.
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