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
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A Prestwick3_000859 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prestwick3_000859, including repackagers and relabelers. The FDA regulates Prestwick3_000859 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prestwick3_000859 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Prestwick3_000859 supplier is an individual or a company that provides Prestwick3_000859 active pharmaceutical ingredient (API) or Prestwick3_000859 finished formulations upon request. The Prestwick3_000859 suppliers may include Prestwick3_000859 API manufacturers, exporters, distributors and traders.
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A Prestwick3_000859 DMF (Drug Master File) is a document detailing the whole manufacturing process of Prestwick3_000859 active pharmaceutical ingredient (API) in detail. Different forms of Prestwick3_000859 DMFs exist exist since differing nations have different regulations, such as Prestwick3_000859 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prestwick3_000859 DMF submitted to regulatory agencies in the US is known as a USDMF. Prestwick3_000859 USDMF includes data on Prestwick3_000859's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prestwick3_000859 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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