01 1Kyowa Hakko Bio
02 1Sato Yakuhin Kogyo Co., Ltd
01 1ACEGLUTAMIDE ALUMINUM GRANULES (KW-110)
02 1ACEGLUTAMIDE GRANULES (BULK)
01 2Japan
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5314
Submission : 1984-04-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5343
Submission : 1984-04-11
Status : Inactive
Type : II
A Aceglutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aceglutamide, including repackagers and relabelers. The FDA regulates Aceglutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aceglutamide 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 Aceglutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aceglutamide supplier is an individual or a company that provides Aceglutamide active pharmaceutical ingredient (API) or Aceglutamide finished formulations upon request. The Aceglutamide suppliers may include Aceglutamide API manufacturers, exporters, distributors and traders.
click here to find a list of Aceglutamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aceglutamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Aceglutamide active pharmaceutical ingredient (API) in detail. Different forms of Aceglutamide DMFs exist exist since differing nations have different regulations, such as Aceglutamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aceglutamide DMF submitted to regulatory agencies in the US is known as a USDMF. Aceglutamide USDMF includes data on Aceglutamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aceglutamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aceglutamide suppliers with USDMF on PharmaCompass.
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