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