API Suppliers
US DMFs Filed
CEP/COS Certifications
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JDMFs Filed
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EU WC
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Listed Suppliers
0
USA (Orange Book)
Europe
Canada
Australia
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South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
30
PharmaCompass offers a list of Insulin 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 Insulin manufacturer or Insulin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Insulin manufacturer or Insulin supplier.
PharmaCompass also assists you with knowing the Insulin API Price utilized in the formulation of products. Insulin API Price is not always fixed or binding as the Insulin Price is obtained through a variety of data sources. The Insulin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Insulin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Insulin, including repackagers and relabelers. The FDA regulates Insulin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Insulin 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Insulin supplier is an individual or a company that provides Insulin active pharmaceutical ingredient (API) or Insulin finished formulations upon request. The Insulin suppliers may include Insulin API manufacturers, exporters, distributors and traders.
click here to find a list of Insulin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Insulin DMF (Drug Master File) is a document detailing the whole manufacturing process of Insulin active pharmaceutical ingredient (API) in detail. Different forms of Insulin DMFs exist exist since differing nations have different regulations, such as Insulin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Insulin DMF submitted to regulatory agencies in the US is known as a USDMF. Insulin USDMF includes data on Insulin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Insulin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Insulin 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Insulin 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Insulin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Insulin suppliers with NDC on PharmaCompass.
Insulin 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 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 GMP manufacturer or Insulin GMP API supplier for your needs.
A Insulin CoA (Certificate of Analysis) is a formal document that attests to Insulin's compliance with Insulin specifications and serves as a tool for batch-level quality control.
Insulin CoA mostly includes findings from lab analyses of a specific batch. For each Insulin 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Insulin EP), Insulin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Insulin USP).