01 2Biovectra Inc
02 1NOF CORPORATION
01 120 KDA MPEG-O-2-METHYLPROPIONALDEHYDE
02 1METHOXYPOLY (ETHYLENE GLYCOL)-PROPYLALDEHYDE MW 20000
03 1MPEG PROPIONALDEHYDE 20,000 DA
01 2Canada
02 1Japan
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30207
Submission : 2016-01-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20435
Submission : 2007-04-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20029
Submission : 2006-12-10
Status : Active
Type : II
A Isobutyraldehyde manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isobutyraldehyde, including repackagers and relabelers. The FDA regulates Isobutyraldehyde manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isobutyraldehyde 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 Isobutyraldehyde supplier is an individual or a company that provides Isobutyraldehyde active pharmaceutical ingredient (API) or Isobutyraldehyde finished formulations upon request. The Isobutyraldehyde suppliers may include Isobutyraldehyde API manufacturers, exporters, distributors and traders.
click here to find a list of Isobutyraldehyde suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Isobutyraldehyde DMF (Drug Master File) is a document detailing the whole manufacturing process of Isobutyraldehyde active pharmaceutical ingredient (API) in detail. Different forms of Isobutyraldehyde DMFs exist exist since differing nations have different regulations, such as Isobutyraldehyde USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Isobutyraldehyde DMF submitted to regulatory agencies in the US is known as a USDMF. Isobutyraldehyde USDMF includes data on Isobutyraldehyde's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Isobutyraldehyde USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Isobutyraldehyde suppliers with USDMF on PharmaCompass.
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