01 1F.I.S. Fabbrica Italiana Sintetici
02 1TATEYAMA KASEI CO LTD
01 1QUAZEPAM
02 1QUAZEPAM--BULK DRUG
01 1Italy
02 1Japan
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4386
Submission : 1982-06-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15031
Submission : 2000-09-04
Status : Active
Type : II
A Quazepam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Quazepam, including repackagers and relabelers. The FDA regulates Quazepam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Quazepam 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 Quazepam supplier is an individual or a company that provides Quazepam active pharmaceutical ingredient (API) or Quazepam finished formulations upon request. The Quazepam suppliers may include Quazepam API manufacturers, exporters, distributors and traders.
click here to find a list of Quazepam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Quazepam DMF (Drug Master File) is a document detailing the whole manufacturing process of Quazepam active pharmaceutical ingredient (API) in detail. Different forms of Quazepam DMFs exist exist since differing nations have different regulations, such as Quazepam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Quazepam DMF submitted to regulatory agencies in the US is known as a USDMF. Quazepam USDMF includes data on Quazepam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Quazepam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Quazepam suppliers with USDMF on PharmaCompass.
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