01 13M Company
02 1Arch Pharmalabs
03 1Blank
01 13-PHENYL-5-METHYL ISOXAZOLE-4-CARBONYL CHLORIDE (PMIC CHLORIDE)
02 1BETAPURE NT-P SERIES CARTRIDGE PRODUCTS
03 1CARBONYL CHLORIDE MNFG AT BOUND BROOK, NEW JERSEY
01 1India
02 1U.S.A
03 1Blank
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14467
Submission : 1999-09-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18215
Submission : 2005-03-28
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3902
Submission : 1980-07-16
Status : Inactive
Type : II
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A Phosgene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Phosgene, including repackagers and relabelers. The FDA regulates Phosgene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Phosgene 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 Phosgene supplier is an individual or a company that provides Phosgene active pharmaceutical ingredient (API) or Phosgene finished formulations upon request. The Phosgene suppliers may include Phosgene API manufacturers, exporters, distributors and traders.
click here to find a list of Phosgene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Phosgene DMF (Drug Master File) is a document detailing the whole manufacturing process of Phosgene active pharmaceutical ingredient (API) in detail. Different forms of Phosgene DMFs exist exist since differing nations have different regulations, such as Phosgene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Phosgene DMF submitted to regulatory agencies in the US is known as a USDMF. Phosgene USDMF includes data on Phosgene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Phosgene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Phosgene suppliers with USDMF on PharmaCompass.
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