Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 2Bachem AG
02 1ALP Pharm
03 1AmbioPharm
04 1Amphastar Pharmaceuticals
05 1Asymchem Laboratories
06 1Auro Peptides Limited
07 1Biocon
08 2Chengdu Shengnuo Biopharm
09 1Fresenius SE & Co. KGaA
10 1Hangzhou Jiuyuan Gene Engineering
11 2Hybio Pharmaceutical
12 2Jiangsu Sinopep Allsino Biopharmaceutical
13 1PolyPeptide Group
14 1ScinoPharm Taiwan, Ltd
15 1Shenzhen JYMed Technology
16 1Sun Pharmaceutical Industries Limited
17 1Zhejiang Peptites Biotech Co.,Ltd
18 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 : 2016-10-07
Pay. Date : 2016-05-11
DMF Number : 30467
Submission : 2016-06-29
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 : 2020-11-05
Pay. Date : 2020-08-20
DMF Number : 33366
Submission : 2020-08-31
Status :
Type : II
A Liraglutide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Liraglutide, including repackagers and relabelers. The FDA regulates Liraglutide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Liraglutide 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 Liraglutide supplier is an individual or a company that provides Liraglutide active pharmaceutical ingredient (API) or Liraglutide finished formulations upon request. The Liraglutide suppliers may include Liraglutide API manufacturers, exporters, distributors and traders.
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A Liraglutide DMF (Drug Master File) is a document detailing the whole manufacturing process of Liraglutide active pharmaceutical ingredient (API) in detail. Different forms of Liraglutide DMFs exist exist since differing nations have different regulations, such as Liraglutide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Liraglutide DMF submitted to regulatory agencies in the US is known as a USDMF. Liraglutide USDMF includes data on Liraglutide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Liraglutide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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