Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
01 1HISTRELIN ACETATE
01 1Switzerland
01 1Active
01 1Blank
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 : 16997
Submission : 2003-10-30
Status : Active
Type : II
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A VANTAS manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of VANTAS, including repackagers and relabelers. The FDA regulates VANTAS manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. VANTAS 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 VANTAS supplier is an individual or a company that provides VANTAS active pharmaceutical ingredient (API) or VANTAS finished formulations upon request. The VANTAS suppliers may include VANTAS API manufacturers, exporters, distributors and traders.
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A VANTAS DMF (Drug Master File) is a document detailing the whole manufacturing process of VANTAS active pharmaceutical ingredient (API) in detail. Different forms of VANTAS DMFs exist exist since differing nations have different regulations, such as VANTAS USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A VANTAS DMF submitted to regulatory agencies in the US is known as a USDMF. VANTAS USDMF includes data on VANTAS's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The VANTAS USDMF is kept confidential to protect the manufacturer’s intellectual property.
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