01 4THERMAX LTD CHEMICAL DIV
01 1TULSION THERMACOAT L 100
02 1TULSION(R) 335
03 1TULSION(R) 339
04 1TULSION(R) 344
01 4India
01 4Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15532
Submission : 2001-07-16
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16549
Submission : 2003-04-23
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16548
Submission : 2003-04-23
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16155
Submission : 2002-09-27
Status : Inactive
Type : IV
A Alpha-Methylaconitate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alpha-Methylaconitate, including repackagers and relabelers. The FDA regulates Alpha-Methylaconitate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alpha-Methylaconitate 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 Alpha-Methylaconitate supplier is an individual or a company that provides Alpha-Methylaconitate active pharmaceutical ingredient (API) or Alpha-Methylaconitate finished formulations upon request. The Alpha-Methylaconitate suppliers may include Alpha-Methylaconitate API manufacturers, exporters, distributors and traders.
click here to find a list of Alpha-Methylaconitate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alpha-Methylaconitate DMF (Drug Master File) is a document detailing the whole manufacturing process of Alpha-Methylaconitate active pharmaceutical ingredient (API) in detail. Different forms of Alpha-Methylaconitate DMFs exist exist since differing nations have different regulations, such as Alpha-Methylaconitate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alpha-Methylaconitate DMF submitted to regulatory agencies in the US is known as a USDMF. Alpha-Methylaconitate USDMF includes data on Alpha-Methylaconitate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alpha-Methylaconitate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alpha-Methylaconitate suppliers with USDMF on PharmaCompass.
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