01 1MSN Laboratories
02 1Zhejiang Yongtai Technology
01 1TERT-BUTYL 2-[(4R,6S)-6-[(E)-2-[4-(4-FLUOROPHENYL)-2-[METHYL (METHYLSULFONYL)AMINO]-6-PROPAN-2-YLPYRIMIDIN-5-YL]ETHENYL]-2,2-DIMETHYL-1,3-DIOXAN-4-YL]ACETATE
02 1TERTIARY BUTYL AMINE SALT OF ROSUVASTATIN [ROUTE CODE - ROC1]
01 1China
02 1India
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23599
Submission : 2010-03-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35320
Submission : 2020-10-28
Status : Active
Type : II
A Crestor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Crestor, including repackagers and relabelers. The FDA regulates Crestor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Crestor 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 Crestor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Crestor supplier is an individual or a company that provides Crestor active pharmaceutical ingredient (API) or Crestor finished formulations upon request. The Crestor suppliers may include Crestor API manufacturers, exporters, distributors and traders.
click here to find a list of Crestor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Crestor DMF (Drug Master File) is a document detailing the whole manufacturing process of Crestor active pharmaceutical ingredient (API) in detail. Different forms of Crestor DMFs exist exist since differing nations have different regulations, such as Crestor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Crestor DMF submitted to regulatory agencies in the US is known as a USDMF. Crestor USDMF includes data on Crestor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Crestor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Crestor suppliers with USDMF on PharmaCompass.
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