01 1Apothecon Pharmaceuticals
02 1Dipharma
03 1Viatris
01 3MIGLUSTAT
01 1India
02 1Italy
03 1U.S.A
01 3Active
01 3Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-09-29
Pay. Date : 2023-09-07
DMF Number : 36453
Submission : 2021-11-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-14
Pay. Date : 2015-05-07
DMF Number : 29329
Submission : 2015-06-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-24
Pay. Date : 2013-01-28
DMF Number : 26294
Submission : 2013-03-08
Status : Active
Type : II
A Miglustat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Miglustat, including repackagers and relabelers. The FDA regulates Miglustat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Miglustat 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 Miglustat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Miglustat supplier is an individual or a company that provides Miglustat active pharmaceutical ingredient (API) or Miglustat finished formulations upon request. The Miglustat suppliers may include Miglustat API manufacturers, exporters, distributors and traders.
click here to find a list of Miglustat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Miglustat DMF (Drug Master File) is a document detailing the whole manufacturing process of Miglustat active pharmaceutical ingredient (API) in detail. Different forms of Miglustat DMFs exist exist since differing nations have different regulations, such as Miglustat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Miglustat DMF submitted to regulatory agencies in the US is known as a USDMF. Miglustat USDMF includes data on Miglustat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Miglustat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Miglustat suppliers with USDMF on PharmaCompass.
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