Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1Neuland Laboratories
03 1Abbott Laboratories
04 1Archimica
05 1AstraZeneca
06 1Curia
07 1Emcure Pharmaceuticals
08 1F.I.S. Fabbrica Italiana Sintetici
09 1Harman Finochem
10 1NOVADEL
11 1SI Group
12 1Unimark Remedies 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 : 2013-03-14
Pay. Date : 2012-12-18
DMF Number : 11204
Submission : 1994-11-22
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27418
Submission : 2013-08-13
Status :
Type : II
A Propofol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Propofol, including repackagers and relabelers. The FDA regulates Propofol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Propofol 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 Propofol supplier is an individual or a company that provides Propofol active pharmaceutical ingredient (API) or Propofol finished formulations upon request. The Propofol suppliers may include Propofol API manufacturers, exporters, distributors and traders.
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A Propofol DMF (Drug Master File) is a document detailing the whole manufacturing process of Propofol active pharmaceutical ingredient (API) in detail. Different forms of Propofol DMFs exist exist since differing nations have different regulations, such as Propofol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Propofol DMF submitted to regulatory agencies in the US is known as a USDMF. Propofol USDMF includes data on Propofol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Propofol USDMF is kept confidential to protect the manufacturer’s intellectual property.
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