01 1Novartis Pharmaceuticals Corporation
01 1FLUVASTATIN DRUG SUBSTANCE
01 1Switzerland
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23901
Submission : 2010-06-30
Status : Active
Type : II
A Fluvastatin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluvastatin, including repackagers and relabelers. The FDA regulates Fluvastatin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluvastatin 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 Fluvastatin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluvastatin supplier is an individual or a company that provides Fluvastatin active pharmaceutical ingredient (API) or Fluvastatin finished formulations upon request. The Fluvastatin suppliers may include Fluvastatin API manufacturers, exporters, distributors and traders.
click here to find a list of Fluvastatin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluvastatin DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluvastatin active pharmaceutical ingredient (API) in detail. Different forms of Fluvastatin DMFs exist exist since differing nations have different regulations, such as Fluvastatin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluvastatin DMF submitted to regulatory agencies in the US is known as a USDMF. Fluvastatin USDMF includes data on Fluvastatin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluvastatin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluvastatin suppliers with USDMF on PharmaCompass.
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