Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1Avantor Performance Materials
01 1A, A-TREHALOSE DIHYDRATE, API
02 1TREHALOSE DIHYDRATE
01 2U.S.A
01 2Active
01 2Blank
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 : 33548
Submission : 2019-02-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34595
Submission : 2020-05-06
Status : Active
Type : II
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A D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0%, including repackagers and relabelers. The FDA regulates D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% 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 D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% supplier is an individual or a company that provides D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% active pharmaceutical ingredient (API) or D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% finished formulations upon request. The D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% suppliers may include D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% API manufacturers, exporters, distributors and traders.
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A D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% DMF (Drug Master File) is a document detailing the whole manufacturing process of D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% active pharmaceutical ingredient (API) in detail. Different forms of D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% DMFs exist exist since differing nations have different regulations, such as D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% DMF submitted to regulatory agencies in the US is known as a USDMF. D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% USDMF includes data on D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0%'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The D-(+)-Trehalose dihydrate, SAJ special grade, >=99.0% USDMF is kept confidential to protect the manufacturer’s intellectual property.
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