Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1Debiopharm
03 1Hainan Shuangcheng Pharmaceuticals
01 1TRIPTORELIN
02 1TRIPTORELIN PAMOATE
03 1TRIPTORELIN PAMOATE MICROGRANULES
01 1China
02 2Switzerland
01 3Active
01 3Blank
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 : 6291
Submission : 1986-04-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30364
Submission : 2016-03-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39931
Submission : 2024-06-27
Status : Active
Type : II
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A Ipsen Brand of Triptorelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ipsen Brand of Triptorelin, including repackagers and relabelers. The FDA regulates Ipsen Brand of Triptorelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ipsen Brand of Triptorelin 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 Ipsen Brand of Triptorelin supplier is an individual or a company that provides Ipsen Brand of Triptorelin active pharmaceutical ingredient (API) or Ipsen Brand of Triptorelin finished formulations upon request. The Ipsen Brand of Triptorelin suppliers may include Ipsen Brand of Triptorelin API manufacturers, exporters, distributors and traders.
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A Ipsen Brand of Triptorelin DMF (Drug Master File) is a document detailing the whole manufacturing process of Ipsen Brand of Triptorelin active pharmaceutical ingredient (API) in detail. Different forms of Ipsen Brand of Triptorelin DMFs exist exist since differing nations have different regulations, such as Ipsen Brand of Triptorelin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ipsen Brand of Triptorelin DMF submitted to regulatory agencies in the US is known as a USDMF. Ipsen Brand of Triptorelin USDMF includes data on Ipsen Brand of Triptorelin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ipsen Brand of Triptorelin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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