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
A Lactose Monohydrate API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lactose Monohydrate API, including repackagers and relabelers. The FDA regulates Lactose Monohydrate API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lactose Monohydrate API API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Lactose Monohydrate API supplier is an individual or a company that provides Lactose Monohydrate API active pharmaceutical ingredient (API) or Lactose Monohydrate API finished formulations upon request. The Lactose Monohydrate API suppliers may include Lactose Monohydrate API API manufacturers, exporters, distributors and traders.
click here to find a list of Lactose Monohydrate API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lactose Monohydrate API DMF (Drug Master File) is a document detailing the whole manufacturing process of Lactose Monohydrate API active pharmaceutical ingredient (API) in detail. Different forms of Lactose Monohydrate API DMFs exist exist since differing nations have different regulations, such as Lactose Monohydrate API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lactose Monohydrate API DMF submitted to regulatory agencies in the US is known as a USDMF. Lactose Monohydrate API USDMF includes data on Lactose Monohydrate API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lactose Monohydrate API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lactose Monohydrate API suppliers with USDMF on PharmaCompass.
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