01 1AVT (Shanghai)
02 1BioSpectra
01 1TREHALOSE (FOR INJECTION) (NON-STERILE)
02 1TREHALOSE, DIHYDRATE
01 1China
02 1U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35566
Submission : 2021-01-31
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34764
Submission : 2020-08-04
Status : Active
Type : IV
A Trehalose API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trehalose API, including repackagers and relabelers. The FDA regulates Trehalose API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trehalose 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.
A Trehalose API supplier is an individual or a company that provides Trehalose API active pharmaceutical ingredient (API) or Trehalose API finished formulations upon request. The Trehalose API suppliers may include Trehalose API API manufacturers, exporters, distributors and traders.
click here to find a list of Trehalose API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trehalose API DMF (Drug Master File) is a document detailing the whole manufacturing process of Trehalose API active pharmaceutical ingredient (API) in detail. Different forms of Trehalose API DMFs exist exist since differing nations have different regulations, such as Trehalose API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trehalose API DMF submitted to regulatory agencies in the US is known as a USDMF. Trehalose API USDMF includes data on Trehalose API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trehalose API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trehalose API suppliers with USDMF on PharmaCompass.
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