Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1ALP Pharm
03 1BCN Peptides
04 1Chengdu Shengnuo Biopharm
05 1Ipsen
06 1Jiangsu Sinopep Allsino Biopharmaceutical
07 1Sun Pharmaceutical Industries Limited
08 1Blank
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-03
Pay. Date : 2019-02-01
DMF Number : 33336
Submission : 2019-02-08
Status :
Type : II
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A Somatuline Depot manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Somatuline Depot, including repackagers and relabelers. The FDA regulates Somatuline Depot manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Somatuline Depot 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 Somatuline Depot supplier is an individual or a company that provides Somatuline Depot active pharmaceutical ingredient (API) or Somatuline Depot finished formulations upon request. The Somatuline Depot suppliers may include Somatuline Depot API manufacturers, exporters, distributors and traders.
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A Somatuline Depot DMF (Drug Master File) is a document detailing the whole manufacturing process of Somatuline Depot active pharmaceutical ingredient (API) in detail. Different forms of Somatuline Depot DMFs exist exist since differing nations have different regulations, such as Somatuline Depot USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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