01 13D IMAGING DRUG DESIGN AND DEVELOPMENT LLC
01 1ZIRCONIUM-89 OXALATE
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31399
Submission : 2017-02-22
Status : Active
Type : II
A Zirconium Oxalate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zirconium Oxalate, including repackagers and relabelers. The FDA regulates Zirconium Oxalate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zirconium Oxalate 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 Oxalate supplier is an individual or a company that provides Zirconium Oxalate active pharmaceutical ingredient (API) or Zirconium Oxalate finished formulations upon request. The Zirconium Oxalate suppliers may include Zirconium Oxalate API manufacturers, exporters, distributors and traders.
click here to find a list of Zirconium Oxalate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Zirconium Oxalate DMF (Drug Master File) is a document detailing the whole manufacturing process of Zirconium Oxalate active pharmaceutical ingredient (API) in detail. Different forms of Zirconium Oxalate DMFs exist exist since differing nations have different regulations, such as Zirconium Oxalate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zirconium Oxalate DMF submitted to regulatory agencies in the US is known as a USDMF. Zirconium Oxalate USDMF includes data on Zirconium Oxalate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zirconium Oxalate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zirconium Oxalate suppliers with USDMF on PharmaCompass.
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