01 1ORGANICA Feinchemie GmbH Wolfen
01 1STRONTIUM 87M GENERATOR
01 1Germany
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1482
Submission : 1970-02-06
Status : Inactive
Type : II
A Strontium-87 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Strontium-87, including repackagers and relabelers. The FDA regulates Strontium-87 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Strontium-87 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 Strontium-87 supplier is an individual or a company that provides Strontium-87 active pharmaceutical ingredient (API) or Strontium-87 finished formulations upon request. The Strontium-87 suppliers may include Strontium-87 API manufacturers, exporters, distributors and traders.
click here to find a list of Strontium-87 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Strontium-87 DMF (Drug Master File) is a document detailing the whole manufacturing process of Strontium-87 active pharmaceutical ingredient (API) in detail. Different forms of Strontium-87 DMFs exist exist since differing nations have different regulations, such as Strontium-87 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Strontium-87 DMF submitted to regulatory agencies in the US is known as a USDMF. Strontium-87 USDMF includes data on Strontium-87's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Strontium-87 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Strontium-87 suppliers with USDMF on PharmaCompass.
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