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
A Trehalose Dihydrate API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trehalose Dihydrate API, including repackagers and relabelers. The FDA regulates Trehalose Dihydrate API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trehalose Dihydrate API 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 Trehalose Dihydrate API manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trehalose Dihydrate API supplier is an individual or a company that provides Trehalose Dihydrate API active pharmaceutical ingredient (API) or Trehalose Dihydrate API finished formulations upon request. The Trehalose Dihydrate API suppliers may include Trehalose Dihydrate API API manufacturers, exporters, distributors and traders.
click here to find a list of Trehalose Dihydrate API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trehalose Dihydrate API DMF (Drug Master File) is a document detailing the whole manufacturing process of Trehalose Dihydrate API active pharmaceutical ingredient (API) in detail. Different forms of Trehalose Dihydrate API DMFs exist exist since differing nations have different regulations, such as Trehalose Dihydrate API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trehalose Dihydrate API DMF submitted to regulatory agencies in the US is known as a USDMF. Trehalose Dihydrate API USDMF includes data on Trehalose Dihydrate API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trehalose Dihydrate API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trehalose Dihydrate API suppliers with USDMF on PharmaCompass.
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