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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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NDC
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
JDMF
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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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 : 32703
Submission : 2018-06-08
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 : 2015-05-07
Pay. Date : 2015-04-27
DMF Number : 18277
Submission : 2005-04-12
Status :
Type : II
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ABOUT THIS PAGE
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PharmaCompass offers a list of Glucagon 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 Glucagon manufacturer or Glucagon supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Glucagon manufacturer or Glucagon supplier.
PharmaCompass also assists you with knowing the Glucagon API Price utilized in the formulation of products. Glucagon API Price is not always fixed or binding as the Glucagon Price is obtained through a variety of data sources. The Glucagon Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Glucagone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glucagone, including repackagers and relabelers. The FDA regulates Glucagone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glucagone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Glucagone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glucagone supplier is an individual or a company that provides Glucagone active pharmaceutical ingredient (API) or Glucagone finished formulations upon request. The Glucagone suppliers may include Glucagone API manufacturers, exporters, distributors and traders.
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A Glucagone DMF (Drug Master File) is a document detailing the whole manufacturing process of Glucagone active pharmaceutical ingredient (API) in detail. Different forms of Glucagone DMFs exist exist since differing nations have different regulations, such as Glucagone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glucagone DMF submitted to regulatory agencies in the US is known as a USDMF. Glucagone USDMF includes data on Glucagone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glucagone USDMF is kept confidential to protect the manufacturer’s intellectual property.
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The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Glucagone Drug Master File in Japan (Glucagone JDMF) empowers Glucagone API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Glucagone JDMF during the approval evaluation for pharmaceutical products. At the time of Glucagone JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Glucagone suppliers with JDMF on PharmaCompass.
A Glucagone CEP of the European Pharmacopoeia monograph is often referred to as a Glucagone Certificate of Suitability (COS). The purpose of a Glucagone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Glucagone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Glucagone to their clients by showing that a Glucagone CEP has been issued for it. The manufacturer submits a Glucagone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Glucagone CEP holder for the record. Additionally, the data presented in the Glucagone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Glucagone DMF.
A Glucagone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Glucagone CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Glucagone suppliers with CEP (COS) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Glucagone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Glucagone API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Glucagone as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Glucagone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Glucagone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Glucagone suppliers with NDC on PharmaCompass.
Glucagone 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 Glucagone 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 Glucagone GMP manufacturer or Glucagone GMP API supplier for your needs.
A Glucagone CoA (Certificate of Analysis) is a formal document that attests to Glucagone's compliance with Glucagone specifications and serves as a tool for batch-level quality control.
Glucagone CoA mostly includes findings from lab analyses of a specific batch. For each Glucagone 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.
Glucagone may be tested according to a variety of international standards, such as European Pharmacopoeia (Glucagone EP), Glucagone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glucagone USP).
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