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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PharmaCompass offers a list of Triptorelin Pamoate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Triptorelin Pamoate manufacturer or Triptorelin Pamoate supplier for your needs.
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A Triptorelin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Triptorelin, including repackagers and relabelers. The FDA regulates Triptorelin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Triptorelin supplier is an individual or a company that provides Triptorelin active pharmaceutical ingredient (API) or Triptorelin finished formulations upon request. The Triptorelin suppliers may include Triptorelin API manufacturers, exporters, distributors and traders.
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A Triptorelin DMF (Drug Master File) is a document detailing the whole manufacturing process of Triptorelin active pharmaceutical ingredient (API) in detail. Different forms of Triptorelin DMFs exist exist since differing nations have different regulations, such as Triptorelin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Triptorelin DMF submitted to regulatory agencies in the US is known as a USDMF. Triptorelin USDMF includes data on Triptorelin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Triptorelin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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