01 1Cambridge Isotope Laboratories
02 1Center of Molecular Research
03 1HUAYI ISOTOPE CO
04 1Rotem Industries
05 1TAIYO NIPPON SANSO CORP
01 1China
02 1Israel
03 1Japan
04 1Russia
05 1U.S.A
01 4Active
02 1Inactive
01 5Blank
01 5Blank
01 5Blank
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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 : 25469
Submission : 2011-10-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21848
Submission : 2008-07-30
Status : Active
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 : 17418
Submission : 2004-05-26
Status : Inactive
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.
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