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