Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1BrightGene Bio-Medical Technology Co.,Ltd
03 2Lonza Group
04 1Teva Pharmaceutical Industries
01 4VOCLOSPORIN
02 1VOCLOSPORIN (IE-001)
01 1China
02 1Israel
03 1Spain
04 2Switzerland
01 4Active
02 1Inactive
01 3Complete
02 2Blank
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-11
Pay. Date : 2024-07-19
DMF Number : 40162
Submission : 2024-08-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-19
Pay. Date : 2024-07-11
DMF Number : 39556
Submission : 2024-07-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33779
Submission : 2020-04-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23335
Submission : 2009-12-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-08-09
Pay. Date : 2024-06-10
DMF Number : 40089
Submission : 2024-07-24
Status : Active
Type : II
A Voclosporin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Voclosporin, including repackagers and relabelers. The FDA regulates Voclosporin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Voclosporin 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 Voclosporin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Voclosporin supplier is an individual or a company that provides Voclosporin active pharmaceutical ingredient (API) or Voclosporin finished formulations upon request. The Voclosporin suppliers may include Voclosporin API manufacturers, exporters, distributors and traders.
click here to find a list of Voclosporin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Voclosporin DMF (Drug Master File) is a document detailing the whole manufacturing process of Voclosporin active pharmaceutical ingredient (API) in detail. Different forms of Voclosporin DMFs exist exist since differing nations have different regulations, such as Voclosporin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Voclosporin DMF submitted to regulatory agencies in the US is known as a USDMF. Voclosporin USDMF includes data on Voclosporin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Voclosporin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Voclosporin suppliers with USDMF on PharmaCompass.
We have 4 companies offering Voclosporin
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