Xellia Delivering Reliable Anti-Infective Solutions Through Expertise, Quality, and Uninterrupted Global Supply.
01 1Xellia Pharmaceuticals
02 4BrightGene Bio-Medical Technology Co.,Ltd
03 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
04 1Yacht Bio-Technology
01 4DALBAVANCIN HYDROCHLORIDE
02 1DALBAVANCIN HYDROCHLORIDE (DB)
03 1DALBAVANCIN PRECURSOR A40926
04 1DALBAVANCIN PRECURSOR A40926 (CBR48)
01 6China
02 1Denmark
01 5Active
02 2Inactive
01 3Complete
02 4Blank
Xellia Delivering Reliable Anti-Infective Solutions Through Expertise, Quality, and Uninterrupted Global Supply.
GDUFA
DMF Review : Complete
Rev. Date : 2024-04-23
Pay. Date : 2024-01-29
DMF Number : 39378
Submission : 2024-03-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-18
Pay. Date : 2022-12-12
DMF Number : 37186
Submission : 2022-11-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37185
Submission : 2022-09-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36025
Submission : 2021-08-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35874
Submission : 2021-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-01
Pay. Date : 2021-05-10
DMF Number : 35428
Submission : 2021-01-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40827
Submission : 2024-12-13
Status : Active
Type : II
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PharmaCompass offers a list of Dalbavancin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Dalbavancin manufacturer or Dalbavancin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dalbavancin manufacturer or Dalbavancin supplier.
A Zeven manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zeven, including repackagers and relabelers. The FDA regulates Zeven manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zeven 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 Zeven manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Zeven supplier is an individual or a company that provides Zeven active pharmaceutical ingredient (API) or Zeven finished formulations upon request. The Zeven suppliers may include Zeven API manufacturers, exporters, distributors and traders.
click here to find a list of Zeven suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Zeven DMF (Drug Master File) is a document detailing the whole manufacturing process of Zeven active pharmaceutical ingredient (API) in detail. Different forms of Zeven DMFs exist exist since differing nations have different regulations, such as Zeven USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Zeven DMF submitted to regulatory agencies in the US is known as a USDMF. Zeven USDMF includes data on Zeven's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Zeven USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Zeven suppliers with USDMF on PharmaCompass.
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