01 1Biocon
02 1Concord Biotech
03 1Fresenius Kabi AB Brunna
04 1Sandoz B2B
05 1Sun Pharmaceutical Industries Limited
01 5TEMSIROLIMUS
01 3India
02 1Sweden
03 1Switzerland
01 4Active
02 1Inactive
01 3Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-05-15
Pay. Date : 2014-12-08
DMF Number : 28841
Submission : 2015-01-22
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-10
Pay. Date : 2014-03-25
DMF Number : 24921
Submission : 2011-05-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26019
Submission : 2012-05-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24964
Submission : 2011-05-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-01
Pay. Date : 2013-03-15
DMF Number : 26825
Submission : 2013-03-30
Status : Active
Type : II
A Temsirolimus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Temsirolimus, including repackagers and relabelers. The FDA regulates Temsirolimus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Temsirolimus API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Temsirolimus manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Temsirolimus supplier is an individual or a company that provides Temsirolimus active pharmaceutical ingredient (API) or Temsirolimus finished formulations upon request. The Temsirolimus suppliers may include Temsirolimus API manufacturers, exporters, distributors and traders.
click here to find a list of Temsirolimus suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Temsirolimus DMF (Drug Master File) is a document detailing the whole manufacturing process of Temsirolimus active pharmaceutical ingredient (API) in detail. Different forms of Temsirolimus DMFs exist exist since differing nations have different regulations, such as Temsirolimus USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Temsirolimus DMF submitted to regulatory agencies in the US is known as a USDMF. Temsirolimus USDMF includes data on Temsirolimus's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Temsirolimus USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Temsirolimus suppliers with USDMF on PharmaCompass.
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