01 1MK Silicone Products
02 8St. Gobain Performance Plastics
03 1Stepan Company
04 1TOYOX CO LTD
05 6The Dow Chemical Company
06 3Wacker Chemie AG
07 1Blank
01 1DEFOAMER FD 101, FD 102,FD 104, L-500 AND DREWFLOC 225 AND 412
02 1ELASTOSIL(R) LR 3003/20 A/B - RAL 6010
03 1ELASTOSIL(R) LR 3003/30 A/B - RAL 6010
04 1ELASTOSIL(R) LR 3003/70 A/B - RAL 6010
05 1LIVEO™ 7-48XX BIOMEDICAL GRADE LIQUID SILICONE RUBBERS
06 1LIVEO™ UNFILLED SILICONE ELASTOMER GELS
07 1LIVEO™7-4870 BIOMEDICAL GRADE LIQUID SILICONE RUBBER
08 1LIVEO™Q7-9180 SILICONE FLUIDS
09 1SANI-TECH STHT-C
10 1SANI-TECH ULTRA 50 SILICONE TUBING
11 1SANI-TECH® ULTRA 65 SILICONE TUBING
12 1SANITECH 65
13 1SANITECH STHT-C HIGH PURITY SILICONE TUBING
14 1SILASTIC 7-6840 BIOMEDICAL GRADE LIQUID SILICONE RUBBER
15 1SILICONE TRANSPARENT TUBING
16 2SILICONES
17 1TOYOX SILICONE HOSE, TOYOFUSSO HOSE SERIES
18 1TYGON 3350 SANITARY SILICONE TUBING
19 1TYGON 3350 SILICONE TUBING
20 1TYGON 33701B BRAID-REINFORCED SILICONE HOSE
01 8France
02 3Germany
03 1India
04 1Japan
05 7U.S.A
06 1Blank
01 13Active
02 8Inactive
01 21Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23097
Submission : 2009-09-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20262
Submission : 2007-02-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23967
Submission : 2010-07-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23420
Submission : 2009-12-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20233
Submission : 2007-01-31
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18443
Submission : 2005-06-21
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4940
Submission : 1983-03-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18419
Submission : 2005-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18431
Submission : 2005-06-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18429
Submission : 2005-06-13
Status : Active
Type : II
A Silicon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Silicon, including repackagers and relabelers. The FDA regulates Silicon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Silicon 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 Silicon supplier is an individual or a company that provides Silicon active pharmaceutical ingredient (API) or Silicon finished formulations upon request. The Silicon suppliers may include Silicon API manufacturers, exporters, distributors and traders.
click here to find a list of Silicon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Silicon DMF (Drug Master File) is a document detailing the whole manufacturing process of Silicon active pharmaceutical ingredient (API) in detail. Different forms of Silicon DMFs exist exist since differing nations have different regulations, such as Silicon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Silicon DMF submitted to regulatory agencies in the US is known as a USDMF. Silicon USDMF includes data on Silicon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Silicon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Silicon suppliers with USDMF on PharmaCompass.
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