01 1Polydrug Laboratories Private Limited
02 1Siegfried AG
01 14-CHLORBUTANAL SODIUM BISULPHATE ADDUCT
02 1CHLOROBUTANOL (HEMIHYDRATE)
01 1India
02 1Switzerland
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23069
Submission : 2009-08-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9006
Submission : 1991-02-25
Status : Active
Type : II
A Chlorobutanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlorobutanol, including repackagers and relabelers. The FDA regulates Chlorobutanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlorobutanol 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 Chlorobutanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chlorobutanol supplier is an individual or a company that provides Chlorobutanol active pharmaceutical ingredient (API) or Chlorobutanol finished formulations upon request. The Chlorobutanol suppliers may include Chlorobutanol API manufacturers, exporters, distributors and traders.
click here to find a list of Chlorobutanol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chlorobutanol DMF (Drug Master File) is a document detailing the whole manufacturing process of Chlorobutanol active pharmaceutical ingredient (API) in detail. Different forms of Chlorobutanol DMFs exist exist since differing nations have different regulations, such as Chlorobutanol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chlorobutanol DMF submitted to regulatory agencies in the US is known as a USDMF. Chlorobutanol USDMF includes data on Chlorobutanol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chlorobutanol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chlorobutanol suppliers with USDMF on PharmaCompass.
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