01 1Lupin Ltd
02 1Meiji Seika Pharma
03 1Orchid Pharma
04 1Sun Pharmaceutical Industries Limited
05 1ZHEJIANG HUAFANG PHARMACEUTICAL CO LTD
01 3CEFDITOREN PIVOXIL
02 2CEFDITOREN PIVOXIL DRUG SUBSTANCE
01 1China
02 3India
03 1Japan
01 2Active
02 3Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23544
Submission : 2010-04-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17482
Submission : 2004-06-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20292
Submission : 2007-02-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19011
Submission : 2005-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25086
Submission : 2011-06-12
Status : Active
Type : II
79
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A CAS-117467-28-4 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-117467-28-4, including repackagers and relabelers. The FDA regulates CAS-117467-28-4 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-117467-28-4 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 CAS-117467-28-4 supplier is an individual or a company that provides CAS-117467-28-4 active pharmaceutical ingredient (API) or CAS-117467-28-4 finished formulations upon request. The CAS-117467-28-4 suppliers may include CAS-117467-28-4 API manufacturers, exporters, distributors and traders.
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A CAS-117467-28-4 DMF (Drug Master File) is a document detailing the whole manufacturing process of CAS-117467-28-4 active pharmaceutical ingredient (API) in detail. Different forms of CAS-117467-28-4 DMFs exist exist since differing nations have different regulations, such as CAS-117467-28-4 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A CAS-117467-28-4 DMF submitted to regulatory agencies in the US is known as a USDMF. CAS-117467-28-4 USDMF includes data on CAS-117467-28-4's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CAS-117467-28-4 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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