Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
01 1Metrochem API Private Limited
02 1Aurobindo Pharma Limited
03 1Lupin Ltd
04 1MSN Laboratories
05 1Teva Pharmaceutical Industries
01 5MIGALASTAT HYDROCHLORIDE
01 4India
02 1Israel
01 5Active
01 3Complete
02 2Blank
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37632
Submission : 2023-02-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-08
Pay. Date : 2022-02-25
DMF Number : 36827
Submission : 2022-02-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-06-09
Pay. Date : 2022-05-26
DMF Number : 36729
Submission : 2022-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38135
Submission : 2023-03-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-03-17
Pay. Date : 2021-12-15
DMF Number : 36618
Submission : 2022-02-28
Status : Active
Type : II
A Migalastat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Migalastat, including repackagers and relabelers. The FDA regulates Migalastat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Migalastat 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 Migalastat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Migalastat supplier is an individual or a company that provides Migalastat active pharmaceutical ingredient (API) or Migalastat finished formulations upon request. The Migalastat suppliers may include Migalastat API manufacturers, exporters, distributors and traders.
click here to find a list of Migalastat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Migalastat DMF (Drug Master File) is a document detailing the whole manufacturing process of Migalastat active pharmaceutical ingredient (API) in detail. Different forms of Migalastat DMFs exist exist since differing nations have different regulations, such as Migalastat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Migalastat DMF submitted to regulatory agencies in the US is known as a USDMF. Migalastat USDMF includes data on Migalastat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Migalastat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Migalastat suppliers with USDMF on PharmaCompass.
We have 5 companies offering Migalastat
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