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API SUPPLIERS
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
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USDMF
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 : 34276
Submission : 2019-11-21
Status :
Type : II
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ABOUT THIS PAGE
A Dasiglucagon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dasiglucagon, including repackagers and relabelers. The FDA regulates Dasiglucagon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dasiglucagon API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Dasiglucagon supplier is an individual or a company that provides Dasiglucagon active pharmaceutical ingredient (API) or Dasiglucagon finished formulations upon request. The Dasiglucagon suppliers may include Dasiglucagon API manufacturers, exporters, distributors and traders.
click here to find a list of Dasiglucagon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dasiglucagon DMF (Drug Master File) is a document detailing the whole manufacturing process of Dasiglucagon active pharmaceutical ingredient (API) in detail. Different forms of Dasiglucagon DMFs exist exist since differing nations have different regulations, such as Dasiglucagon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dasiglucagon DMF submitted to regulatory agencies in the US is known as a USDMF. Dasiglucagon USDMF includes data on Dasiglucagon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dasiglucagon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dasiglucagon suppliers with USDMF on PharmaCompass.
Dasiglucagon Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Dasiglucagon GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Dasiglucagon GMP manufacturer or Dasiglucagon GMP API supplier for your needs.
A Dasiglucagon CoA (Certificate of Analysis) is a formal document that attests to Dasiglucagon's compliance with Dasiglucagon specifications and serves as a tool for batch-level quality control.
Dasiglucagon CoA mostly includes findings from lab analyses of a specific batch. For each Dasiglucagon CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Dasiglucagon may be tested according to a variety of international standards, such as European Pharmacopoeia (Dasiglucagon EP), Dasiglucagon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dasiglucagon USP).
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