01 1ISO TEX DIAGNOSTICS INC
02 1Nordion Canada
03 1PerkinElmer
04 1Blank
01 1YTTRIUM 90 AS REVIALLED IN ONTARIO, CANADA
02 1YTTRIUM-90
03 2YTTRIUM-90 (Y-90)
01 1Canada
02 2U.S.A
03 1Blank
01 1Active
02 3Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14045
Submission : 1999-03-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8342
Submission : 1989-12-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14129
Submission : 1999-05-05
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8735
Submission : 1990-09-13
Status : Inactive
Type : II
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A Yttrium Radioisotopes manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Yttrium Radioisotopes, including repackagers and relabelers. The FDA regulates Yttrium Radioisotopes manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Yttrium Radioisotopes 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 Yttrium Radioisotopes supplier is an individual or a company that provides Yttrium Radioisotopes active pharmaceutical ingredient (API) or Yttrium Radioisotopes finished formulations upon request. The Yttrium Radioisotopes suppliers may include Yttrium Radioisotopes API manufacturers, exporters, distributors and traders.
click here to find a list of Yttrium Radioisotopes suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Yttrium Radioisotopes DMF (Drug Master File) is a document detailing the whole manufacturing process of Yttrium Radioisotopes active pharmaceutical ingredient (API) in detail. Different forms of Yttrium Radioisotopes DMFs exist exist since differing nations have different regulations, such as Yttrium Radioisotopes USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Yttrium Radioisotopes DMF submitted to regulatory agencies in the US is known as a USDMF. Yttrium Radioisotopes USDMF includes data on Yttrium Radioisotopes's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Yttrium Radioisotopes USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Yttrium Radioisotopes suppliers with USDMF on PharmaCompass.
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