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