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 Hemihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chlorobutanol Hemihydrate, including repackagers and relabelers. The FDA regulates Chlorobutanol Hemihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chlorobutanol Hemihydrate 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 Hemihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chlorobutanol Hemihydrate supplier is an individual or a company that provides Chlorobutanol Hemihydrate active pharmaceutical ingredient (API) or Chlorobutanol Hemihydrate finished formulations upon request. The Chlorobutanol Hemihydrate suppliers may include Chlorobutanol Hemihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Chlorobutanol Hemihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chlorobutanol Hemihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Chlorobutanol Hemihydrate active pharmaceutical ingredient (API) in detail. Different forms of Chlorobutanol Hemihydrate DMFs exist exist since differing nations have different regulations, such as Chlorobutanol Hemihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chlorobutanol Hemihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Chlorobutanol Hemihydrate USDMF includes data on Chlorobutanol Hemihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chlorobutanol Hemihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chlorobutanol Hemihydrate suppliers with USDMF on PharmaCompass.
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