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