Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-09
Pay. Date : 2014-04-10
DMF Number : 16760
Submission : 2003-08-13
Status :
Type : II
USV offers custom peptide synthesis ranging from gram to multi-gram to multi-kilogram quantities.
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-16
Pay. Date : 2013-02-27
DMF Number : 24288
Submission : 2010-11-01
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-27
Pay. Date : 2012-11-09
DMF Number : 17777
Submission : 2004-10-21
Status :
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-19
Pay. Date : 2019-09-19
DMF Number : 34145
Submission : 2019-09-27
Status :
Type : II
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 : 38662
Submission : 2023-10-23
Status :
Type : II
A Octreotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Octreotide, including repackagers and relabelers. The FDA regulates Octreotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Octreotide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Octreotide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Octreotide supplier is an individual or a company that provides Octreotide active pharmaceutical ingredient (API) or Octreotide finished formulations upon request. The Octreotide suppliers may include Octreotide API manufacturers, exporters, distributors and traders.
click here to find a list of Octreotide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Octreotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Octreotide active pharmaceutical ingredient (API) in detail. Different forms of Octreotide DMFs exist exist since differing nations have different regulations, such as Octreotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Octreotide DMF submitted to regulatory agencies in the US is known as a USDMF. Octreotide USDMF includes data on Octreotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Octreotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Octreotide suppliers with USDMF on PharmaCompass.
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