01 1Amino Chemicals
02 1Aurobindo Pharma Limited
03 1Hetero Drugs
04 1Quimica Sintetica
05 1RANBAXY LABORATORIES LIMITED
06 1Zhejiang Huahai Pharmaceutical
01 3FOSINOPRIL SODIUM
02 2FOSINOPRIL SODIUM USP
03 1FOSINOPRIL SODIUM USP (NON-STERILE BULK)
01 1China
02 3India
03 1Malta
04 1Spain
01 3Active
02 3Inactive
01 1Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15326
Submission : 2001-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19711
Submission : 2006-08-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16008
Submission : 2002-06-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15934
Submission : 2002-04-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16321
Submission : 2002-12-17
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-06
Pay. Date : 2012-11-23
DMF Number : 17805
Submission : 2004-10-27
Status : Active
Type : II
A Fosinopril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosinopril, including repackagers and relabelers. The FDA regulates Fosinopril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosinopril 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 Fosinopril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fosinopril supplier is an individual or a company that provides Fosinopril active pharmaceutical ingredient (API) or Fosinopril finished formulations upon request. The Fosinopril suppliers may include Fosinopril API manufacturers, exporters, distributors and traders.
click here to find a list of Fosinopril suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fosinopril DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosinopril active pharmaceutical ingredient (API) in detail. Different forms of Fosinopril DMFs exist exist since differing nations have different regulations, such as Fosinopril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosinopril DMF submitted to regulatory agencies in the US is known as a USDMF. Fosinopril USDMF includes data on Fosinopril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosinopril USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosinopril suppliers with USDMF on PharmaCompass.
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