Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1Dr. Reddy's Laboratories
03 1ALP Pharm
04 1BCN Peptides
05 1Chengdu Shengnuo Biopharm
06 1Ipsen
07 1Jiangsu Sinopep Allsino Biopharmaceutical
08 1Sun Pharmaceutical Industries Limited
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
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39768
Submission : 2024-06-28
Status :
Type : II
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PharmaCompass offers a list of Lanreotide Acetate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lanreotide Acetate manufacturer or Lanreotide Acetate supplier for your needs.
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A Lanreotide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lanreotide, including repackagers and relabelers. The FDA regulates Lanreotide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lanreotide 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 Lanreotide supplier is an individual or a company that provides Lanreotide active pharmaceutical ingredient (API) or Lanreotide finished formulations upon request. The Lanreotide suppliers may include Lanreotide API manufacturers, exporters, distributors and traders.
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A Lanreotide DMF (Drug Master File) is a document detailing the whole manufacturing process of Lanreotide active pharmaceutical ingredient (API) in detail. Different forms of Lanreotide DMFs exist exist since differing nations have different regulations, such as Lanreotide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lanreotide DMF submitted to regulatory agencies in the US is known as a USDMF. Lanreotide USDMF includes data on Lanreotide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lanreotide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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