Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
01 1STREPTOZOTOCIN (S-119)
01 1U.S.A
01 1Active
01 1Blank
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2614
Submission : 1976-02-17
Status : Active
Type : II
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A Streptozocin, Zanosar, STZ,Streptozotocin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Streptozocin, Zanosar, STZ,Streptozotocin, including repackagers and relabelers. The FDA regulates Streptozocin, Zanosar, STZ,Streptozotocin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Streptozocin, Zanosar, STZ,Streptozotocin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Streptozocin, Zanosar, STZ,Streptozotocin DMF (Drug Master File) is a document detailing the whole manufacturing process of Streptozocin, Zanosar, STZ,Streptozotocin active pharmaceutical ingredient (API) in detail. Different forms of Streptozocin, Zanosar, STZ,Streptozotocin DMFs exist exist since differing nations have different regulations, such as Streptozocin, Zanosar, STZ,Streptozotocin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Streptozocin, Zanosar, STZ,Streptozotocin DMF submitted to regulatory agencies in the US is known as a USDMF. Streptozocin, Zanosar, STZ,Streptozotocin USDMF includes data on Streptozocin, Zanosar, STZ,Streptozotocin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Streptozocin, Zanosar, STZ,Streptozotocin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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