01 1CURIUM US LLC
02 1Dr. Paul Lohmann GmbH KG
03 1Isotopes Incl
04 1Blank
01 1RADIOCHEMICAL STRONTIUM CHLORIDE SR-82
02 1STRONTIUM CHLORIDE (SR-82) API STARTING MATERIAL
03 1STRONTIUM SR-89 CHLORIDE
04 1STRONTIUM Sr-82 CONCENTRATE
01 1Germany
02 2U.S.A
03 1Blank
01 1Active
02 3Inactive
01 4Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31438
Submission : 2017-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7571
Submission : 1988-07-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14704
Submission : 2000-02-02
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7423
Submission : 1988-04-12
Status : Inactive
Type : II
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A Strontium-89 Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Strontium-89 Chloride, including repackagers and relabelers. The FDA regulates Strontium-89 Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Strontium-89 Chloride 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-89 Chloride supplier is an individual or a company that provides Strontium-89 Chloride active pharmaceutical ingredient (API) or Strontium-89 Chloride finished formulations upon request. The Strontium-89 Chloride suppliers may include Strontium-89 Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Strontium-89 Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Strontium-89 Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Strontium-89 Chloride active pharmaceutical ingredient (API) in detail. Different forms of Strontium-89 Chloride DMFs exist exist since differing nations have different regulations, such as Strontium-89 Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Strontium-89 Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Strontium-89 Chloride USDMF includes data on Strontium-89 Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Strontium-89 Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Strontium-89 Chloride suppliers with USDMF on PharmaCompass.
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