01 3DFE Pharma
02 1India Phosphate
03 1Kerry
01 1LACTOSE MONOHYDRATE USP
02 1PHARMATOSE 200 M (DPI QUALITY)
03 1PHARMATOSE DCL 21
04 1PHARMATOSE® DCL 11
05 1SHEFFIELD BRAND MONOHYDRATE NF INHALATION 120MS
01 3Germany
02 1India
03 1U.S.A
01 4Active
02 1Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17576
Submission : 2004-07-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15917
Submission : 2002-03-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17577
Submission : 2004-07-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34463
Submission : 2020-01-31
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21596
Submission : 2008-05-07
Status : Inactive
Type : IV
44
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A UNII-EWQ57Q8I5X manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of UNII-EWQ57Q8I5X, including repackagers and relabelers. The FDA regulates UNII-EWQ57Q8I5X manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. UNII-EWQ57Q8I5X API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A UNII-EWQ57Q8I5X supplier is an individual or a company that provides UNII-EWQ57Q8I5X active pharmaceutical ingredient (API) or UNII-EWQ57Q8I5X finished formulations upon request. The UNII-EWQ57Q8I5X suppliers may include UNII-EWQ57Q8I5X API manufacturers, exporters, distributors and traders.
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A UNII-EWQ57Q8I5X DMF (Drug Master File) is a document detailing the whole manufacturing process of UNII-EWQ57Q8I5X active pharmaceutical ingredient (API) in detail. Different forms of UNII-EWQ57Q8I5X DMFs exist exist since differing nations have different regulations, such as UNII-EWQ57Q8I5X USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A UNII-EWQ57Q8I5X DMF submitted to regulatory agencies in the US is known as a USDMF. UNII-EWQ57Q8I5X USDMF includes data on UNII-EWQ57Q8I5X's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The UNII-EWQ57Q8I5X USDMF is kept confidential to protect the manufacturer’s intellectual property.
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