01 1Emcure Pharmaceuticals
02 2Sai Life Sciences Limited
03 1Xian Libang Pharmaceutical Co.,Ltd
01 1China
02 3India
01 2Active
02 2Inactive
01 4Blank
01 4Blank
01 1WC-0130
02 3Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-16
Pay. Date : 2015-09-08
DMF Number : 21470
Submission : 2008-03-08
Status : Active
Type : II
NDC Package Code : 14474-040
Start Marketing Date : 2017-12-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25g/25g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25763
Submission : 2012-03-19
Status : Active
Type : II
NDC Package Code : 14593-858
Start Marketing Date : 2023-12-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21553
Submission : 2008-04-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20252
Submission : 2007-02-06
Status : Inactive
Type : II
Date of Issue : 2022-07-26
Valid Till : 2025-07-14
Written Confirmation Number : WC-0130
Address of the Firm :
NDC Package Code : 14474-040
Start Marketing Date : 2017-12-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25g/25g)
Marketing Category : BULK INGREDIENT
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.
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