01 4BrightGene Bio-Medical Technology Co.,Ltd
02 1Livzon Group Fuzhou Fuxing Pharmaceutical Co., Ltd.
03 1Xellia Pharmaceuticals ApS
01 3DALBAVANCIN HYDROCHLORIDE
02 1DALBAVANCIN HYDROCHLORIDE (DB)
03 1DALBAVANCIN PRECURSOR A40926
04 1DALBAVANCIN PRECURSOR A40926 (CBR48)
01 5China
02 1Denmark
01 6Active
01 4Complete
02 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36025
Submission : 2021-08-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-25
Pay. Date : 2021-09-14
DMF Number : 35874
Submission : 2021-04-30
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 : 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 : Complete
Rev. Date : 2024-04-23
Pay. Date : 2024-01-29
DMF Number : 39378
Submission : 2024-03-27
Status : Active
Type : II
A Dalbavancin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dalbavancin, including repackagers and relabelers. The FDA regulates Dalbavancin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dalbavancin 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 Dalbavancin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dalbavancin supplier is an individual or a company that provides Dalbavancin active pharmaceutical ingredient (API) or Dalbavancin finished formulations upon request. The Dalbavancin suppliers may include Dalbavancin API manufacturers, exporters, distributors and traders.
click here to find a list of Dalbavancin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dalbavancin DMF (Drug Master File) is a document detailing the whole manufacturing process of Dalbavancin active pharmaceutical ingredient (API) in detail. Different forms of Dalbavancin DMFs exist exist since differing nations have different regulations, such as Dalbavancin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dalbavancin DMF submitted to regulatory agencies in the US is known as a USDMF. Dalbavancin USDMF includes data on Dalbavancin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dalbavancin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dalbavancin suppliers with USDMF on PharmaCompass.
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