Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
01 1AC-137
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 : 10068
Submission : 1993-02-04
Status : Active
Type : II
A N-T-Boc-2,5-Dihydropyrrole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N-T-Boc-2,5-Dihydropyrrole, including repackagers and relabelers. The FDA regulates N-T-Boc-2,5-Dihydropyrrole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N-T-Boc-2,5-Dihydropyrrole API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A N-T-Boc-2,5-Dihydropyrrole supplier is an individual or a company that provides N-T-Boc-2,5-Dihydropyrrole active pharmaceutical ingredient (API) or N-T-Boc-2,5-Dihydropyrrole finished formulations upon request. The N-T-Boc-2,5-Dihydropyrrole suppliers may include N-T-Boc-2,5-Dihydropyrrole API manufacturers, exporters, distributors and traders.
click here to find a list of N-T-Boc-2,5-Dihydropyrrole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A N-T-Boc-2,5-Dihydropyrrole DMF (Drug Master File) is a document detailing the whole manufacturing process of N-T-Boc-2,5-Dihydropyrrole active pharmaceutical ingredient (API) in detail. Different forms of N-T-Boc-2,5-Dihydropyrrole DMFs exist exist since differing nations have different regulations, such as N-T-Boc-2,5-Dihydropyrrole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N-T-Boc-2,5-Dihydropyrrole DMF submitted to regulatory agencies in the US is known as a USDMF. N-T-Boc-2,5-Dihydropyrrole USDMF includes data on N-T-Boc-2,5-Dihydropyrrole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N-T-Boc-2,5-Dihydropyrrole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of N-T-Boc-2,5-Dihydropyrrole suppliers with USDMF on PharmaCompass.
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