01 1Cambridge Isotope Laboratories
02 1Center of Molecular Research
03 1HUAYI ISOTOPE CO
04 1Rotem Industries
05 1TAIYO NIPPON SANSO CORP
01 1OXYGEN 18 ENRICHED WATER
02 1OXYGEN-18 ENRICHED WATER
03 1OXYGEN-18 ENRICHED WATER, CIL PART NUMBER OLM-240
04 1OXYGEN-18 WATER
05 1WATER-18O
01 1China
02 1Israel
03 1Japan
04 1Russia
05 1U.S.A
01 4Active
02 1Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17418
Submission : 2004-05-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24614
Submission : 2011-02-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25469
Submission : 2011-10-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19758
Submission : 2006-09-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21848
Submission : 2008-07-30
Status : Active
Type : II
A Water-18O manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Water-18O, including repackagers and relabelers. The FDA regulates Water-18O manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Water-18O 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 Water-18O supplier is an individual or a company that provides Water-18O active pharmaceutical ingredient (API) or Water-18O finished formulations upon request. The Water-18O suppliers may include Water-18O API manufacturers, exporters, distributors and traders.
click here to find a list of Water-18O suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Water-18O DMF (Drug Master File) is a document detailing the whole manufacturing process of Water-18O active pharmaceutical ingredient (API) in detail. Different forms of Water-18O DMFs exist exist since differing nations have different regulations, such as Water-18O USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Water-18O DMF submitted to regulatory agencies in the US is known as a USDMF. Water-18O USDMF includes data on Water-18O's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Water-18O USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Water-18O suppliers with USDMF on PharmaCompass.
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