Synopsis
Synopsis
0
CEP/COS
0
EU WC
0
KDMF
0
NDC API
0
VMF
DRUG PRODUCT COMPOSITIONS
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
1. 28(b)-lys-29(b)-pro-insulin
2. 28(b)-lysine-29(b)-prolineinsulin
3. Humalog
4. Humalog Kwikpen
5. Insulin, Lys(28b)-pro(29b)-
6. Insulin, Lysyl(28b)-prolyl(28b)-
7. Kwikpen, Humalog
8. Lispro
9. Lispro, Insulin
10. Lyspro
1. 133107-64-9
2. Insulin Lispro (5.97 Mg)
3. Insulin-lispro
4. Dtxsid90157956
Molecular Weight | 5814 g/mol |
---|---|
Molecular Formula | C257H389N65O77S6 |
Hydrogen Bond Donor Count | 84 |
Hydrogen Bond Acceptor Count | 89 |
Rotatable Bond Count | 185 |
Exact Mass | 5811.6913101 g/mol |
Monoisotopic Mass | 5809.6846004 g/mol |
Topological Polar Surface Area | 2310 Ų |
Heavy Atom Count | 405 |
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 | Humalog |
PubMed Health | Insulin Lispro |
Drug Classes | Antidiabetic |
Drug Label | Humalog Mix50/50 [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)] is a mixture of insulin lispro solution, a rapid-acting blood glucose-lowering agent and insulin lispro protamine suspension, an intermedi... |
Active Ingredient | Insulin lispro recombinant |
Dosage Form | Injectable |
Route | Injection |
Strength | 100 units/ml |
Market Status | Prescription |
Company | Lilly |
2 of 2 | |
---|---|
Drug Name | Humalog |
PubMed Health | Insulin Lispro |
Drug Classes | Antidiabetic |
Drug Label | Humalog Mix50/50 [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)] is a mixture of insulin lispro solution, a rapid-acting blood glucose-lowering agent and insulin lispro protamine suspension, an intermedi... |
Active Ingredient | Insulin lispro recombinant |
Dosage Form | Injectable |
Route | Injection |
Strength | 100 units/ml |
Market Status | Prescription |
Company | Lilly |
Insulin lispro is indicated to improve glycemic control in adults and children with diabetes mellitus.
FDA Label
Treatment of diabetes mellitus in adults.
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Insulin lispro Sanofi is also indicated for the initial stabilisation of diabetes mellitus.
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilisation of diabetes mellitus.
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes mellitus.
For the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Liprolog is also indicated for the initial stabilization of diabetes mellitus. Liprolog is a short acting insulin and may be used in conjunction with a longer acting human insulin. Liprolog is indicated for preprandial administration.
Insulin is a natural hormone produced by beta cells of the pancreas. In non-diabetic individuals, a basal level of insulin is supplemented with insulin spikes following meals. Increased insulin secretion following meals is responsible for the metabolic changes that occur as the body transitions from a postabsorptive to absorptive state. Insulin promotes cellular uptake of glucose, particularly in muscle and adipose tissues, promotes energy storage via glycogenesis, opposes catabolism of energy stores, increases DNA replication and protein synthesis by stimulating amino acid uptake by liver, muscle and adipose tissue, and modifies the activity of numerous enzymes involved in glycogen synthesis and glycolysis. Insulin also promotes growth and is required for the actions of growth hormone (e.g. protein synthesis, cell division, DNA synthesis). Insulin lispro is a rapid-acting insulin analogue used to mimic postprandial insulin spikes in diabetic individuals. The onset of action of insulin lispro is 10-15 minutes. Its activity peaks 60 minutes following subcutaneous injection and its duration of action is 4-5 hours. Compared to regular human insulin, insulin lispro has a more rapid onset of action and a shorter duration of action. Insulin lispro is also shown to be equipotent to human insulin on a molar basis.
Hypoglycemic Agents
Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)
A10AB04
A10AB04
A10AB04, A10AD04
A10AB04, A10AD04
A10AB04
A - Alimentary tract and metabolism
A10 - Drugs used in diabetes
A10A - Insulins and analogues
A10AB - Insulins and analogues for injection, fast-acting
A10AB04 - Insulin lispro
A - Alimentary tract and metabolism
A10 - Drugs used in diabetes
A10A - Insulins and analogues
A10AC - Insulins and analogues for injection, intermediate-acting
A10AC04 - Insulin lispro
A - Alimentary tract and metabolism
A10 - Drugs used in diabetes
A10A - Insulins and analogues
A10AD - Insulins and analogues for injection, intermediate- or long-acting combined with fast-acting
A10AD04 - Insulin lispro
Absorption
Insulin lispro is rapidly absorbed following subcutaneous administration. It is also absorbed more quickly than regular human insulin. Peak serum levels occur 30-90 minutes after injection in healthy subjects. Absorption also differs depending on the site of injection. After insulin lispro was administered in the abdomen, serum drug levels were higher and the duration of action was slightly shorter than after deltoid or thigh administration. The absolute bioavailability after subcutaneous injection ranges from 55% to 77% with doses between 0.1 to 0.2 unit/kg, inclusive. The mean observed area under the serum insulin concentration-time curve from time zero to infinity was 2360 pmol hr/L and 2390 pmol hr/L for HUMALOG U-200 and HUMALOG U-100, respectively. The corresponding mean peak serum insulin concentration was 795 pmol/L and 909 pmol/L for HUMALOG U-200 and HUMALOG U-100, respectively. The median time to maximum concentration was 1.0 hour for both formulations.
Volume of Distribution
When administered intravenously as bolus injections of 0.1 and 0.2 U/kg dose in two separate groups of healthy subjects, the mean volume of distribution of insulin lispro appeared to decrease with increase in dose (1.55 and 0.72 L/kg, respectively).
Clearance
Clearance is dose dependent. When a dose of 0.1 unit/kg and 0.2 unit/kg were administered intravenously, the mean clearance was 21.0 mL/min/kg and 9.6 mL/min/kg respectively.
Insulin is predominantly cleared by metabolic degradation via a receptor-mediated process.
After subcutaneous administration of insulin lispro, the t1/2 is shorter than that of regular human insulin (1 versus 1.5 hours, respectively).
Insulin lispro binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor autophosphorylates and phosphorylates numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. Activation of these proteins leads to the activation of downstream signaling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC), both of which play critical roles in metabolism and catabolism. In humans, insulin is stored in the form of hexamers; however, only insulin monomers are able to interact with IR. Reversal of the proline and lysine residues at positions B28 and B29 of native insulin eliminates hydrophobic interactions and weakens some of the hydrogen bonds that contribute to the stability of the insulin dimers that comprise insulin hexamers. Hexamers of insulin lispro are produced in the presence of zinc and m-cresol. These weakly associated hexamers quickly dissociate upon subcutaneous injection and are absorbed as monomers through vascular endothelial cells. These properties give insulin lispro its fast-acting properties.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4846
Submission : 1983-03-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23892
Submission : 2010-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5527
Submission : 1984-09-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5533
Submission : 1984-09-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17123
Submission : 2004-01-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27702
Submission : 2013-11-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32125
Submission : 2017-12-01
Status : Inactive
Type : II
Registration Number : 303MF10175
Registrant's Address : 65th Infantry Road, Km. 12.6, Carolina, Puerto Rico 00985
Initial Date of Registration : 2021-12-09
Latest Date of Registration :
Registration Number : 217MF10534
Registrant's Address : Lilly Corporate Center, Indianapolis, Indiana 46285, USA
Initial Date of Registration : 2005-09-09
Latest Date of Registration :
Registration Number : 219MF10053
Registrant's Address : 65th Infantry Road, Km. 12.6, Carolina, Puerto Rico 00985
Initial Date of Registration : 2007-03-05
Latest Date of Registration :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4846
Submission : 1983-03-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23892
Submission : 2010-06-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17123
Submission : 2004-01-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32125
Submission : 2017-12-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27702
Submission : 2013-11-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5533
Submission : 1984-09-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5527
Submission : 1984-09-14
Status : Inactive
Type : II
Insulin lispro (genetical recombination)
Registration Number : 303MF10175
Registrant's Address : 65th Infantry Road, Km. 12.6, Carolina, Puerto Rico 00985
Initial Date of Registration : 2021-12-09
Latest Date of Registration : 2021-12-09
Insulin lispro (genetical recombination)
Registration Number : 226MF10225
Registrant's Address : Lilly Corporate Center, Indianapolis, Indiana 46285, USA
Initial Date of Registration : 2014-12-08
Latest Date of Registration : 2017-12-25
Insulin lispro (genetical recombination)
Registration Number : 217MF10534
Registrant's Address : Lilly Corporate Center, Indianapolis, Indiana 46285, USA
Initial Date of Registration : 2005-09-09
Latest Date of Registration : 2017-12-25
Insulin lispro (genetical recombination)
Registration Number : 229MF10064
Registrant's Address : 65th Infantry Road, Km. 12.6, Carolina, Puerto Rico 00985
Initial Date of Registration : 2017-03-13
Latest Date of Registration : 2017-12-25
Insulin lispro (genetical recombination)
Registration Number : 219MF10053
Registrant's Address : 65th Infantry Road, Km. 12.6, Carolina, Puerto Rico 00985
Initial Date of Registration : 2007-03-05
Latest Date of Registration : 2017-12-25
About the Company : Wanbang Biopharmaceuticals is a leading anti-diabetic pharmaceutical company in China and a core member of Fosun Group (SH600196; HK02196). Wanbang Biopharma has been focusing at t...
Details:
Insulin Lispro is a Peptide drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Diabetes Mellitus, Type 1.
Lead Product(s): Insulin Lispro,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 04, 2019
Lead Product(s) : Insulin Lispro,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Insulin Lispro is a Peptide drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Diabetes Mellitus, Type 1.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
April 04, 2019
Details:
Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 1.
Lead Product(s): Insulin Glargine,Insulin Lispro,Insulin aspart,Insulin Glulisine
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Peptide, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 24, 2017
Lead Product(s) : Insulin Glargine,Insulin Lispro,Insulin aspart,Insulin Glulisine
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Insulin Glargine is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 1.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
August 24, 2017
Details:
SAR342434 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Diabetes Mellitus, Type 1.
Lead Product(s): SAR342434,Insulin Lispro
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 11, 2015
Lead Product(s) : SAR342434,Insulin Lispro
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Assessment of the Safety of SAR342434 and Humalog® When Administered as Continuous Subcutaneous...
Details : SAR342434 is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Diabetes Mellitus, Type 1.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
November 11, 2015
Details:
Human Insulin is a Protein drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Lead Product(s): Insulin Lispro,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Protein
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 28, 2012
Lead Product(s) : Insulin Lispro,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy and Safety of Insuman Basal/Comb/Rapid in Patients With Type 2 Diabetes
Details : Human Insulin is a Protein drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
June 28, 2012
Details:
Human Insulin is a Protein drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diabetes Mellitus, Type 2.
Lead Product(s): Insulin Lispro,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Protein
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 13, 2011
Lead Product(s) : Insulin Lispro,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Assessment of Efficacy and Safety of Insuman Comb 25 Versus Novolin® 30R Twice Daily Over 24 We...
Details : Human Insulin is a Protein drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diabetes Mellitus, Type 2.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
May 13, 2011
Details:
Human Insulin is a Protein drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diabetes Mellitus, Type 1.
Lead Product(s): Insulin Lispro,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Protein
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 03, 2010
Lead Product(s) : Insulin Lispro,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Human Insulin is a Protein drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diabetes Mellitus, Type 1.
Product Name : Undisclosed
Product Type : Protein
Upfront Cash : Inapplicable
September 03, 2010
Details:
Haloperidol is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of unspecified medical condition.
Lead Product(s): Haloperidol,Insulin Lispro,Sodium Chloride
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Physician Services Incorporated
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 07, 2025
Lead Product(s) : Haloperidol,Insulin Lispro,Sodium Chloride
Therapeutic Area : Undisclosed
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Physician Services Incorporated
Deal Size : Inapplicable
Deal Type : Inapplicable
Do Antipsychotics Block Insulin Action in the Brain: is it a Class Effect?
Details : Haloperidol is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of unspecified medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 07, 2025
Details:
Through the acquisition, Lupin will enhance its portfolio and gain the right to commercialize Humulin N (human insulin) in India. It is indicated for the treatment of diabetes mellitus.
Lead Product(s): Insulin Lispro,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Humulin N
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Lupin Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 30, 2024
Lead Product(s) : Insulin Lispro,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Lupin Ltd
Deal Size : Undisclosed
Deal Type : Acquisition
Lupin Acquires Huminsulin from Lilly, Enhance Diabetes Portfolio
Details : Through the acquisition, Lupin will enhance its portfolio and gain the right to commercialize Humulin N (human insulin) in India. It is indicated for the treatment of diabetes mellitus.
Product Name : Humulin N
Product Type : Peptide, Unconjugated
Upfront Cash : Undisclosed
December 30, 2024
Details:
Humalog (insulin) is a peptide based drug, works by showing agonistic action for GLP-1R, mainly indicated for the treatment of patients with type 1 and 2 diabetes.
Lead Product(s): Insulin Lispro,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Humalog
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Sponsor: Eli Lilly
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 17, 2024
Lead Product(s) : Insulin Lispro,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Eli Lilly
Deal Size : Inapplicable
Deal Type : Inapplicable
Lilly, EVA Pharma Announce Regulatory Approval for Locally Manufactured Insulin
Details : Humalog (insulin) is a peptide based drug, works by showing agonistic action for GLP-1R, mainly indicated for the treatment of patients with type 1 and 2 diabetes.
Product Name : Humalog
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
December 17, 2024
Details:
Insulin Lispro is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Lead Product(s): Insulin Lispro,Insulin Glargine
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Peptide, Unconjugated
Sponsor: Cipla
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 17, 2024
Lead Product(s) : Insulin Lispro,Insulin Glargine
Therapeutic Area : Endocrinology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Cipla
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India
Details : Insulin Lispro is a Peptide drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetes Mellitus, Type 2.
Product Name : Undisclosed
Product Type : Peptide, Unconjugated
Upfront Cash : Inapplicable
April 17, 2024
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD :
TE Code :
Brand Name : ADMELOG
Dosage Form : SOLUTION;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 1000 UNITS/10ML (100 UNITS/ML)
Approval Date :
Application Number : 209196
RX/OTC/DISCN :
RLD :
TE Code :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD :
TE Code :
Brand Name : ADMELOG SOLOSTAR
Dosage Form : SOLUTION;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 300 UNITS/3ML (100 UNITS/ML)
Approval Date :
Application Number : 209196
RX/OTC/DISCN :
RLD :
TE Code :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RLD :
TE Code :
Brand Name : ADMELOG
Dosage Form : SOLUTION;INTRAVENOUS, SUBCUTANEOUS
Dosage Strength : 300 UNITS/3ML (100 UNITS/ML)
Approval Date :
Application Number : 209196
RX/OTC/DISCN :
RLD :
TE Code :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Basal
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Comb 25
Dosage Form : Injection fluid, suspension
Dosage Strength : 100 IE/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Norway
Brand Name : Insuman Rapid
Dosage Form : Injection fluid, resolution
Dosage Strength : 100 IE/ml
Packaging : Sylinderampulle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Insuman Infusat
Dosage Form : Injectable Solution
Dosage Strength : 100IU/ml
Packaging :
Approval Date : 11/11/1998
Application Number : 19970221000111
Regulatory Info : Approved
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Approved
Registration Country : Sweden
Human Insulin (Soluble); Human Insulin Isophane (NPH)
Brand Name : Insuman Comb 25 Solostar
Dosage Form : Suspension For Injection
Dosage Strength : 100IU/ml
Packaging :
Approval Date : 31/10/2008
Application Number : 20081016000103
Regulatory Info : Approved
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Approved
Registration Country : Sweden
Human Insulin (Soluble); Human Insulin Isophane (NPH)
Brand Name : Insuman Comb 50
Dosage Form : Injectable Solution
Dosage Strength : 100IU/ml
Packaging :
Approval Date : 11/11/1998
Application Number : 19970221000098
Regulatory Info : Approved
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Deregistered
Registration Country : Sweden
Human Insulin (Soluble); Human Insulin Isophane (NPH)
Brand Name : Insulin Human Winthrop Comb 15
Dosage Form : Injectable Solution
Dosage Strength : 100IU/ml
Packaging :
Approval Date : 17/01/2007
Application Number : 20060824000116
Regulatory Info : Deregistered
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Deregistered
Registration Country : Sweden
Human Insulin (Soluble); Human Insulin Isophane (NPH)
Brand Name : Insulin Human Winthrop Comb 25
Dosage Form : Injectable Solution
Dosage Strength : 100IU/ml
Packaging :
Approval Date : 17/01/2007
Application Number : 20060824000147
Regulatory Info : Deregistered
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Deregistered
Registration Country : Sweden
Human Insulin (Soluble); Human Insulin Isophane (NPH)
Brand Name : Insulin Human Winthrop Comb 25
Dosage Form : Injectable Solution
Dosage Strength : 100IU/ml
Packaging :
Approval Date : 17/01/2007
Application Number : 20060824000154
Regulatory Info : Deregistered
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Deregistered
Registration Country : Sweden
Human Insulin (Soluble); Human Insulin Isophane (NPH)
Brand Name : Insulin Human Winthrop Comb 30
Dosage Form : Injectable Solution
Dosage Strength : 100IU/ml
Packaging :
Approval Date : 19/02/2009
Application Number : 20080112000109
Regulatory Info : Deregistered
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : ADMELOG
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 3ML CARTRIDGE
Approval Date :
Application Number : 2469898
Regulatory Info : Schedule D
Registration Country : Canada
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : ADMELOG SOLOSTAR
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 3ML PREFILLED PEN
Approval Date :
Application Number : 2469871
Regulatory Info : Schedule D
Registration Country : Canada
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : ADMELOG
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 10ML VIAL
Approval Date :
Application Number : 2469901
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : HUMALOG
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 3/10ML
Approval Date :
Application Number : 2229704
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : HUMALOG (CARTRIDGE)
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 1.5/3ML
Approval Date :
Application Number : 2229705
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
INSULIN LISPRO PROTAMINE SUSPENSION
Brand Name : HUMALOG MIX 50 (CARTRIDGE)
Dosage Form : SUSPENSION
Dosage Strength : 50UNIT/ML
Packaging : 3.0ML
Approval Date :
Application Number : 2240297
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : HUMALOG MIX 50 (CARTRIDGE)
Dosage Form : SUSPENSION
Dosage Strength : 50UNIT/ML
Packaging : 3.0ML
Approval Date :
Application Number : 2240297
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
INSULIN LISPRO PROTAMINE SUSPENSION
Brand Name : HUMALOG MIX 25 (KWIKPEN)
Dosage Form : SUSPENSION
Dosage Strength : 75UNIT/ML
Packaging :
Approval Date :
Application Number : 2403420
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
INSULIN LISPRO PROTAMINE SUSPENSION
Brand Name : HUMALOG MIX 50 (KWIKPEN)
Dosage Form : SUSPENSION
Dosage Strength : 50UNIT/ML
Packaging : 3ML/PEN
Approval Date :
Application Number : 2403439
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : HUMALOG 200 UNITS/ML KWIKPEN
Dosage Form : SOLUTION
Dosage Strength : 200UNIT/ML
Packaging : 3ML
Approval Date :
Application Number : 2439611
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Humalog U200 Kwikpen
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Humalog KwikPen
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Humalog
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Humalog
Dosage Form :
Dosage Strength :
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Related Excipient Companies
Excipients by Applications
Global Sales Information
Company : Sanofi-Aventis
Insulin Lispro
Drug Cost (USD) : 1,393,724
Year : 2023
Prescribers : 4971
Prescriptions : 10933
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Sanofi-Aventis
Insulin Lispro
Drug Cost (USD) : 4,074,927
Year : 2023
Prescribers : 11113
Prescriptions : 24807
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Eli Lilly & Co.
Insulin Lispro
Drug Cost (USD) : 458,058,582
Year : 2023
Prescribers : 156031
Prescriptions : 572082
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Eli Lilly & Co.
Insulin Lispro
Drug Cost (USD) : 9,905,950
Year : 2023
Prescribers : 5648
Prescriptions : 15111
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Eli Lilly & Co.
Insulin Lispro
Drug Cost (USD) : 1,208,385,334
Year : 2023
Prescribers : 418431
Prescriptions : 1363952
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Eli Lilly & Co.
Insulin Lispro
Drug Cost (USD) : 224,440,404
Year : 2023
Prescribers : 40611
Prescriptions : 143978
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Eli Lilly & Co.
Insulin Lispro Protamin/Lispro
Drug Cost (USD) : 6,085,553
Year : 2023
Prescribers : 1297
Prescriptions : 6483
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Eli Lilly & Co.
Insulin Lispro Protamin/Lispro
Drug Cost (USD) : 20,294,452
Year : 2023
Prescribers : 3890
Prescriptions : 16268
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Eli Lilly & Co.
Insulin Lispro Protamin/Lispro
Drug Cost (USD) : 59,917,382
Year : 2023
Prescribers : 12749
Prescriptions : 62177
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Company : Eli Lilly & Co.
Insulin Lispro Protamin/Lispro
Drug Cost (USD) : 213,875,690
Year : 2023
Prescribers : 40527
Prescriptions : 171187
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Main Therapeutic Indication : Diabetes
Currency : USD
2019 Revenue in Millions : 273
2018 Revenue in Millions : 101
Growth (%) : 169
Main Therapeutic Indication : Diabetes
Currency : USD
2018 Revenue in Millions : 105
2017 Revenue in Millions : 0
Growth (%) : NA
Main Therapeutic Indication : Diabetes
Currency : USD
2020 Revenue in Millions : 2,626
2019 Revenue in Millions : 2,821
Growth (%) : -7
Main Therapeutic Indication : Diabetes
Currency : USD
2021 Revenue in Millions : 2,453
2020 Revenue in Millions : 2,626
Growth (%) : -7
Main Therapeutic Indication : Diabetes
Currency : USD
2022 Revenue in Millions : 2,061
2021 Revenue in Millions : 2,453
Growth (%) : -16
Main Therapeutic Indication : Diabetes
Currency : USD
2023 Revenue in Millions : 1,663
2022 Revenue in Millions : 2,061
Growth (%) : -19
Main Therapeutic Indication : Diabetes
Currency : USD
2024 Revenue in Millions : 2,325
2023 Revenue in Millions : 1,663
Growth (%) : 40
Main Therapeutic Indication : Diabetes
Currency : USD
2015 Revenue in Millions : 2,785
2014 Revenue in Millions : 2,842
Growth (%) : 2%
Main Therapeutic Indication : Diabetes
Currency : USD
2014 Revenue in Millions : 6.70%
2013 Revenue in Millions :
Growth (%) :
Main Therapeutic Indication : Diabetes
Currency : USD
2016 Revenue in Millions : 2,769
2015 Revenue in Millions : 2,842
Growth (%) : -3
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
41
PharmaCompass offers a list of Insulin Lispro 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 Lispro manufacturer or Insulin Lispro supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Insulin Lispro manufacturer or Insulin Lispro supplier.
PharmaCompass also assists you with knowing the Insulin Lispro API Price utilized in the formulation of products. Insulin Lispro API Price is not always fixed or binding as the Insulin Lispro Price is obtained through a variety of data sources. The Insulin Lispro Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Insulin Lispro manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Insulin Lispro, including repackagers and relabelers. The FDA regulates Insulin Lispro manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Insulin Lispro 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 Lispro manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Insulin Lispro supplier is an individual or a company that provides Insulin Lispro active pharmaceutical ingredient (API) or Insulin Lispro finished formulations upon request. The Insulin Lispro suppliers may include Insulin Lispro API manufacturers, exporters, distributors and traders.
click here to find a list of Insulin Lispro suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Insulin Lispro DMF (Drug Master File) is a document detailing the whole manufacturing process of Insulin Lispro active pharmaceutical ingredient (API) in detail. Different forms of Insulin Lispro DMFs exist exist since differing nations have different regulations, such as Insulin Lispro USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Insulin Lispro DMF submitted to regulatory agencies in the US is known as a USDMF. Insulin Lispro USDMF includes data on Insulin Lispro's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Insulin Lispro USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Insulin Lispro suppliers with USDMF on PharmaCompass.
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 Insulin Lispro Drug Master File in Japan (Insulin Lispro JDMF) empowers Insulin Lispro 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 Insulin Lispro JDMF during the approval evaluation for pharmaceutical products. At the time of Insulin Lispro 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 Insulin Lispro suppliers with JDMF on PharmaCompass.
Insulin Lispro 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 Lispro 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 Lispro GMP manufacturer or Insulin Lispro GMP API supplier for your needs.
A Insulin Lispro CoA (Certificate of Analysis) is a formal document that attests to Insulin Lispro's compliance with Insulin Lispro specifications and serves as a tool for batch-level quality control.
Insulin Lispro CoA mostly includes findings from lab analyses of a specific batch. For each Insulin Lispro 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 Lispro may be tested according to a variety of international standards, such as European Pharmacopoeia (Insulin Lispro EP), Insulin Lispro JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Insulin Lispro USP).