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1. Dtxsid10151274
Molecular Weight | 5832 g/mol |
---|---|
Molecular Formula | C256H387N65O79S6 |
Hydrogen Bond Donor Count | 86 |
Hydrogen Bond Acceptor Count | 91 |
Rotatable Bond Count | 188 |
Exact Mass | 5829.6654893 g/mol |
Monoisotopic Mass | 5827.6587796 g/mol |
Topological Polar Surface Area | 2350 Ų |
Heavy Atom Count | 406 |
Formal Charge | 0 |
Complexity | 13000 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 52 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Novolog |
PubMed Health | Insulin Aspart Protamine/Insulin Aspart (Injection) |
Drug Classes | Antidiabetic |
Drug Label | NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) is a human insulin analog suspension containing 70% insulin aspart protamine crystals and 30% soluble insulin aspart. NovoLog Mix 70/30 is a b... |
Active Ingredient | Insulin aspart recombinant |
Dosage Form | Injectable |
Route | Subcutaneous |
Strength | 1000 units/10ml (100 units/ml) |
Market Status | Prescription |
Company | Novo Nordisk |
2 of 2 | |
---|---|
Drug Name | Novolog |
PubMed Health | Insulin Aspart Protamine/Insulin Aspart (Injection) |
Drug Classes | Antidiabetic |
Drug Label | NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart injection, [rDNA origin]) is a human insulin analog suspension containing 70% insulin aspart protamine crystals and 30% soluble insulin aspart. NovoLog Mix 70/30 is a b... |
Active Ingredient | Insulin aspart recombinant |
Dosage Form | Injectable |
Route | Subcutaneous |
Strength | 1000 units/10ml (100 units/ml) |
Market Status | Prescription |
Company | Novo Nordisk |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32700
Submission : 2018-05-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27184
Submission : 2013-05-15
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39605
Submission : 2024-03-14
Status : Active
Type : II
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Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Insulin aspart manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Insulin aspart, including repackagers and relabelers. The FDA regulates Insulin aspart manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Insulin aspart 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 Insulin aspart supplier is an individual or a company that provides Insulin aspart active pharmaceutical ingredient (API) or Insulin aspart finished formulations upon request. The Insulin aspart suppliers may include Insulin aspart API manufacturers, exporters, distributors and traders.
click here to find a list of Insulin aspart suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Insulin aspart DMF (Drug Master File) is a document detailing the whole manufacturing process of Insulin aspart active pharmaceutical ingredient (API) in detail. Different forms of Insulin aspart DMFs exist exist since differing nations have different regulations, such as Insulin aspart USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Insulin aspart DMF submitted to regulatory agencies in the US is known as a USDMF. Insulin aspart USDMF includes data on Insulin aspart's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Insulin aspart USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Insulin aspart 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 aspart as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Insulin aspart 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 aspart 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 aspart and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Insulin aspart NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Insulin aspart suppliers with NDC on PharmaCompass.
Insulin aspart 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 aspart 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 aspart GMP manufacturer or Insulin aspart GMP API supplier for your needs.
A Insulin aspart CoA (Certificate of Analysis) is a formal document that attests to Insulin aspart's compliance with Insulin aspart specifications and serves as a tool for batch-level quality control.
Insulin aspart CoA mostly includes findings from lab analyses of a specific batch. For each Insulin aspart 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 aspart may be tested according to a variety of international standards, such as European Pharmacopoeia (Insulin aspart EP), Insulin aspart JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Insulin aspart USP).
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