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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Huayi Isotope Co to the U.S. FDA. Original Data : FDA Website

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01 18F-FDG REAGENT KITS (1)

02 Cryptand 222 (1)

03 GOZETOTIDE FOR RADIOPHARMACEUTICAL PREPARATIONS (PSMA-11) (1)

04 MANNOSE TRIFLATE (1)

05 NON-PRODUCT SPECIFIC DOCUMENTATION FOR STERILIZATION PROCESS VALIDATION APPLICATIONS FOR HUMAN AND VETERINARY DRUG PRODUCTS (1)

06 OXYGEN-18 WATER (1)

07 RK-100 (1)

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01 HUAYI ISOTOPE CO (1)

02 HUAYI ISOTOPES CO (5)

03 HUAYI ISOTOPES CORP (1)

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01 China (7)

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01 Active (4)

02 Inactive (3)

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01 Blank (7)

URL Supplier Web Content
HUAYI ISOTOPES CO
Active
30323
N/A
2016-01-18
II
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HUAYI ISOTOPES CO
Active
21089
N/A
2007-11-16
II
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HUAYI ISOTOPES CORP
Inactive
22515
N/A
2009-01-16
II
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HUAYI ISOTOPES CO
Active
25469
N/A
2011-10-10
II
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HUAYI ISOTOPES CO
Inactive
25468
N/A
2011-10-19
II
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Cryptand 222

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HUAYI ISOTOPE CO
Inactive
21142
N/A
2007-11-28
II
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GOZETOTIDE FOR RADIOPHARMACEUTICAL ...

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HUAYI ISOTOPES CO
Active
38399
N/A
2023-10-18
II
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