01 1Baxter Healthcare Corporation
02 1Bayer AG
03 1CSL
04 1Italfarmaco S.p.A
05 8Laboratorios Farmaceuticos Rovi
06 1Luitpold Pharmaceuticals, Inc.
07 1Merck Serono
08 1Otsuka Chemical Co Ltd
09 1Teva Pharmaceutical Industries
10 1Vetter Pharma-Fertigung GmbH & Co
11 1Blank
01 5STERILE WATER FOR INJECTION
02 1STERILE WATER FOR INJECTION 10 ML PREFILLED SYRINGE
03 1STERILE WATER FOR INJECTION 2.2ML PREFILLED SYRINGE
04 1STERILE WATER FOR INJECTION FOR RECONSTITUTION
05 2STERILE WATER FOR INJECTION USP
06 1STERILE WATER FOR INJECTION USP 0.5 ML
07 1STERILE WATER FOR INJECTION USP 2.0 ML
08 1STERILE WATER FOR INJECTION USP, 2 ML VIAL
09 1STERILE WATER FOR INJECTION, 0.5-1.0 ML PREFILLED SYRINGE
10 1STERILE WATER FOR INJECTION, 1 ML PREFILLED SYRINGE
11 1STERILE WATER FOR INJECTION, 5-10 ML PREFILLED SYRINGE
12 1STERILE WATER FOR INJECTION, USP, 5.0 ML
13 1STERILE WATER FOR INJECTION,USP
01 1Australia
02 3Germany
03 1Israel
04 1Italy
05 1Japan
06 8Spain
07 2U.S.A
08 1Blank
01 8Active
02 10Inactive
01 18Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15925
Submission : 2002-04-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19257
Submission : 2006-03-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30419
Submission : 2016-03-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26758
Submission : 2012-12-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25234
Submission : 2011-08-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37945
Submission : 2023-01-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23992
Submission : 2010-07-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30768
Submission : 2016-07-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10473
Submission : 1993-09-14
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10696
Submission : 1994-01-25
Status : Inactive
Type : II
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A Water manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Water, including repackagers and relabelers. The FDA regulates Water manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Water 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 Water manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Water supplier is an individual or a company that provides Water active pharmaceutical ingredient (API) or Water finished formulations upon request. The Water suppliers may include Water API manufacturers, exporters, distributors and traders.
click here to find a list of Water suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Water DMF (Drug Master File) is a document detailing the whole manufacturing process of Water active pharmaceutical ingredient (API) in detail. Different forms of Water DMFs exist exist since differing nations have different regulations, such as Water USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Water DMF submitted to regulatory agencies in the US is known as a USDMF. Water USDMF includes data on Water's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Water USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Water suppliers with USDMF on PharmaCompass.
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