01 1Emcure Pharmaceuticals
02 2Sai Life Sciences Limited
03 1Xian Libang Pharmaceutical Co.,Ltd
01 1IBUTILIDE FUMARATE
02 2IBUTILIDE FUMARATE USP
03 1IBUTILIDE FUMARATE, NON-STERILE BULK DRUG
01 1China
02 3India
01 2Active
02 2Inactive
01 1Complete
02 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25763
Submission : 2012-03-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-16
Pay. Date : 2015-09-08
DMF Number : 21470
Submission : 2008-03-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20252
Submission : 2007-02-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21553
Submission : 2008-04-14
Status : Inactive
Type : II
A Ibutilide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibutilide, including repackagers and relabelers. The FDA regulates Ibutilide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibutilide 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 Ibutilide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ibutilide supplier is an individual or a company that provides Ibutilide active pharmaceutical ingredient (API) or Ibutilide finished formulations upon request. The Ibutilide suppliers may include Ibutilide API manufacturers, exporters, distributors and traders.
click here to find a list of Ibutilide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ibutilide DMF (Drug Master File) is a document detailing the whole manufacturing process of Ibutilide active pharmaceutical ingredient (API) in detail. Different forms of Ibutilide DMFs exist exist since differing nations have different regulations, such as Ibutilide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ibutilide DMF submitted to regulatory agencies in the US is known as a USDMF. Ibutilide USDMF includes data on Ibutilide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ibutilide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ibutilide suppliers with USDMF on PharmaCompass.
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