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PharmaCompass offers a list of Degludec 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 Degludec manufacturer or Degludec supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Degludec manufacturer or Degludec supplier.
PharmaCompass also assists you with knowing the Degludec API Price utilized in the formulation of products. Degludec API Price is not always fixed or binding as the Degludec Price is obtained through a variety of data sources. The Degludec Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A insulin degludec manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of insulin degludec, including repackagers and relabelers. The FDA regulates insulin degludec manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. insulin degludec 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 insulin degludec manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A insulin degludec supplier is an individual or a company that provides insulin degludec active pharmaceutical ingredient (API) or insulin degludec finished formulations upon request. The insulin degludec suppliers may include insulin degludec API manufacturers, exporters, distributors and traders.
click here to find a list of insulin degludec suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A insulin degludec DMF (Drug Master File) is a document detailing the whole manufacturing process of insulin degludec active pharmaceutical ingredient (API) in detail. Different forms of insulin degludec DMFs exist exist since differing nations have different regulations, such as insulin degludec USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A insulin degludec DMF submitted to regulatory agencies in the US is known as a USDMF. insulin degludec USDMF includes data on insulin degludec's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The insulin degludec USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of insulin degludec suppliers with USDMF 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 insulin degludec as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for insulin degludec 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 insulin degludec 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 insulin degludec and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a insulin degludec NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of insulin degludec suppliers with NDC on PharmaCompass.
insulin degludec 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 insulin degludec 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 insulin degludec GMP manufacturer or insulin degludec GMP API supplier for your needs.
A insulin degludec CoA (Certificate of Analysis) is a formal document that attests to insulin degludec's compliance with insulin degludec specifications and serves as a tool for batch-level quality control.
insulin degludec CoA mostly includes findings from lab analyses of a specific batch. For each insulin degludec 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.
insulin degludec may be tested according to a variety of international standards, such as European Pharmacopoeia (insulin degludec EP), insulin degludec JP (Japanese Pharmacopeia) and the US Pharmacopoeia (insulin degludec USP).
