01 1NCM USA
02 1Blank
01 1ZIRCONIUM
02 1ZIRCONIUM-89 (ZR-89) OXALATE SOLUTION
01 1U.S.A
02 1Blank
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28783
Submission : 2014-10-27
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 212
Submission : 1940-01-01
Status : Inactive
Type : II
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A Zirconium-89 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zirconium-89, including repackagers and relabelers. The FDA regulates Zirconium-89 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zirconium-89 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 Zirconium-89 supplier is an individual or a company that provides Zirconium-89 active pharmaceutical ingredient (API) or Zirconium-89 finished formulations upon request. The Zirconium-89 suppliers may include Zirconium-89 API manufacturers, exporters, distributors and traders.
click here to find a list of Zirconium-89 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zirconium-89 DMF (Drug Master File) is a document detailing the whole manufacturing process of Zirconium-89 active pharmaceutical ingredient (API) in detail. Different forms of Zirconium-89 DMFs exist exist since differing nations have different regulations, such as Zirconium-89 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zirconium-89 DMF submitted to regulatory agencies in the US is known as a USDMF. Zirconium-89 USDMF includes data on Zirconium-89's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zirconium-89 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zirconium-89 suppliers with USDMF on PharmaCompass.
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