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