01 1Biocon
02 1Chongqing DaXin Pharmaceutical
03 1Ercros
04 2Livzon New North River Pharmaceutical
05 2Zhejiang Hisun Pharmaceutical
01 2COMPACTIN
02 1COMPACTIN (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT)
03 2MEVASTATIN
04 2MEVASTATIN (NON-STERILE, BULK FORM)
01 5China
02 1India
03 1Spain
01 4Active
02 3Inactive
01 7Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16049
Submission : 2002-07-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28531
Submission : 2014-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19411
Submission : 2006-04-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20273
Submission : 2007-01-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18540
Submission : 2005-07-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22227
Submission : 2008-11-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17434
Submission : 2004-05-25
Status : Inactive
Type : II
A Mevastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mevastatin, including repackagers and relabelers. The FDA regulates Mevastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mevastatin 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 Mevastatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mevastatin supplier is an individual or a company that provides Mevastatin active pharmaceutical ingredient (API) or Mevastatin finished formulations upon request. The Mevastatin suppliers may include Mevastatin API manufacturers, exporters, distributors and traders.
click here to find a list of Mevastatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mevastatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Mevastatin active pharmaceutical ingredient (API) in detail. Different forms of Mevastatin DMFs exist exist since differing nations have different regulations, such as Mevastatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mevastatin DMF submitted to regulatory agencies in the US is known as a USDMF. Mevastatin USDMF includes data on Mevastatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mevastatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mevastatin suppliers with USDMF on PharmaCompass.
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