01 1Bayer AG
02 1Eagle Chemical
03 1Merck Group
01 1MEGLUMINE
02 1MEGLUMINE (D(-) N- METHYLGLUIAMINE)
03 1MEGLUMINE USP
01 2Germany
02 1India
01 2Active
02 1Inactive
01 1Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4308
Submission : 1981-08-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36102
Submission : 2021-07-13
Status : Active
Type : IV
GDUFA
DMF Review : Complete
Rev. Date : 2016-11-10
Pay. Date : 2016-09-30
DMF Number : 3413
Submission : 1978-10-17
Status : Active
Type : II
A Meglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Meglumine, including repackagers and relabelers. The FDA regulates Meglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Meglumine 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 Meglumine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Meglumine supplier is an individual or a company that provides Meglumine active pharmaceutical ingredient (API) or Meglumine finished formulations upon request. The Meglumine suppliers may include Meglumine API manufacturers, exporters, distributors and traders.
click here to find a list of Meglumine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Meglumine DMF (Drug Master File) is a document detailing the whole manufacturing process of Meglumine active pharmaceutical ingredient (API) in detail. Different forms of Meglumine DMFs exist exist since differing nations have different regulations, such as Meglumine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Meglumine DMF submitted to regulatory agencies in the US is known as a USDMF. Meglumine USDMF includes data on Meglumine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Meglumine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Meglumine suppliers with USDMF on PharmaCompass.
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