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
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 :
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 :
Type : II
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A Goserelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Goserelin, including repackagers and relabelers. The FDA regulates Goserelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Goserelin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Goserelin supplier is an individual or a company that provides Goserelin active pharmaceutical ingredient (API) or Goserelin finished formulations upon request. The Goserelin suppliers may include Goserelin API manufacturers, exporters, distributors and traders.
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A Goserelin DMF (Drug Master File) is a document detailing the whole manufacturing process of Goserelin active pharmaceutical ingredient (API) in detail. Different forms of Goserelin DMFs exist exist since differing nations have different regulations, such as Goserelin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Goserelin DMF submitted to regulatory agencies in the US is known as a USDMF. Goserelin USDMF includes data on Goserelin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Goserelin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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