Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 2Bachem AG
02 1ALP Pharm
03 2AstraZeneca
04 1Chemi SpA
01 5GOSERELIN ACETATE
02 1GOSERELIN ACETATE IMPLANT
01 1China
02 1Italy
03 2Switzerland
04 2United Kingdom
01 5Active
02 1Inactive
01 1Complete
02 5Blank
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2020-03-12
Pay. Date : 2019-11-29
DMF Number : 34363
Submission : 2019-12-19
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35689
Submission : 2024-05-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29713
Submission : 2015-09-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31489
Submission : 2017-04-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31488
Submission : 2017-04-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17768
Submission : 2004-10-18
Status : Inactive
Type : II
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A Goserelin acetate (JAN/USP) DMF (Drug Master File) is a document detailing the whole manufacturing process of Goserelin acetate (JAN/USP) active pharmaceutical ingredient (API) in detail. Different forms of Goserelin acetate (JAN/USP) DMFs exist exist since differing nations have different regulations, such as Goserelin acetate (JAN/USP) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Goserelin acetate (JAN/USP) DMF submitted to regulatory agencies in the US is known as a USDMF. Goserelin acetate (JAN/USP) USDMF includes data on Goserelin acetate (JAN/USP)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Goserelin acetate (JAN/USP) USDMF is kept confidential to protect the manufacturer’s intellectual property.
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