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1. Chain, Insulin B
2. Iletin
3. Insulin
4. Insulin A Chain
5. Insulin B Chain
6. Insulin, Regular
7. Insulin, Sodium
8. Insulin, Soluble
9. Novolin
10. Regular Insulin
11. Sodium Insulin
12. Soluble Insulin
1. 9004-10-8
2. Iletin
3. Endopancrine
4. Decurvon
5. Dermulin
6. Humilin
7. Insular
8. Insulyl
9. Iszilin
10. Musulin
11. Insulin-human
12. Dal-insulinum
13. Intesulin B
14. Aerx
15. Insulin, Dalanated
16. Insulina Dalanatada
17. Insulinum Dalanatum
18. Imusay-131
19. Insulin Injection
20. Dalanated Insulin [inn]
21. Insulina Iniettabile Neutra
22. Insulini Injectio Neutralis
23. Injectable Insulini Neutrale
24. Inyectable Neutro De Insulina
25. Ccris 5464
26. Hsdb 3102
27. Insulin, Dalanated [usan:inn]
28. Insulinum Dalanatum [inn-latin]
29. Aerx [insulin Management System]
30. Insulina Dalanatada [inn-spanish]
31. Solute Neutre Injectable D'insuline
32. Hmr 4006
33. Insulina Iniettabile Neutra [dcit]
34. Einecs 232-672-8
35. S.n. 44
36. Insulini Injectio Neutralis [inn-latin]
37. Inyectable Neutro De Insulina [inn-spanish]
38. Solute Neutre Injectable D'insuline [inn-french]
Molecular Weight | 5794 g/mol |
---|---|
Molecular Formula | C256H381N65O77S6 |
XLogP3 | -12.8 |
Hydrogen Bond Donor Count | 78 |
Hydrogen Bond Acceptor Count | 89 |
Rotatable Bond Count | 178 |
Exact Mass | 5791.6287098 g/mol |
Monoisotopic Mass | 5789.6220002 g/mol |
Topological Polar Surface Area | 2450 Ų |
Heavy Atom Count | 404 |
Formal Charge | 0 |
Complexity | 14600 |
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 | 1 |
1 of 2 | |
---|---|
Drug Name | Afrezza |
PubMed Health | Insulin Human Inhaled (Inhalation route) |
Drug Classes | Antidiabetic, Insulin, Rapid Acting |
Active Ingredient | Insulin recombinant human |
Dosage Form | Powder |
Route | Inhalation |
Strength | 4 units/inh; 8 units/inh |
Market Status | Prescription |
Company | Mannkind |
2 of 2 | |
---|---|
Drug Name | Afrezza |
PubMed Health | Insulin Human Inhaled (Inhalation route) |
Drug Classes | Antidiabetic, Insulin, Rapid Acting |
Active Ingredient | Insulin recombinant human |
Dosage Form | Powder |
Route | Inhalation |
Strength | 4 units/inh; 8 units/inh |
Market Status | Prescription |
Company | Mannkind |
INSULIN INJECTION...INSULIN OF CHOICE IN PRESENCE OF UNSTABLE DIABETES WHEN COMPLICATIONS SUCH AS INFECTION, SHOCK, OR SURGICAL TRAUMA OCCUR. ...IS ONLY INSULIN PREPN THAT MAY BE GIVEN IV AS WELL AS SC.
American Medical Association, AMA Department of Drugs, AMA Drug Evaluations. 3rd ed. Littleton, Massachusetts: PSG Publishing Co., Inc., 1977., p. 589
/INSULIN/ HAS BEEN USED TO PRODUCE CONVULSIVE SHOCK SEIZURES FOR TREATMENT OF CERTAIN PSYCHIATRIC CASES. IT IS ALSO USED FOR TREATMENT OF UNDERWEIGHT INDIVIDUALS, PURPOSE BEING TO STIMULATE APPETITE BY LOWERING LEVEL OF BLOOD SUGAR.
Osol, A. and J.E. Hoover, et al. (eds.). Remington's Pharmaceutical Sciences. 15th ed. Easton, Pennsylvania: Mack Publishing Co., 1975., p. 901
RECOMMENDED TECHNIQUE IS TO INJECT INSULIN INTO POCKET BETWEEN FATTY LAYER OF SKIN & UNDERLYING MUSCLE. RECOMMENDED AREAS ARE THIGHS, ABDOMEN, UPPER BACK, & UPPER ARMS. NO ONE SITE IS USED MORE OFTEN THAN EVERY 4-6 WK. PREVENTS TISSUE HYPERTROPHY.
BURKE EL; AMER J NURS 72 (DEC) 2194-6 (1972)
STERILE, ACIDIFIED OR NEUTRAL SOLN OF ACTIVE PRINCIPAL OF PANCREAS WHICH AFFECTS GLUCOSE METABOLISM. CONTAINS 40, 80, 100, OR 500 USP INSULIN UNITS/ML. ... ONSET OF ACTION OCCURS WITHIN 1 HR AFTER SUBCUTANEOUS INJECTION, REACHING ITS MAXIMUM IN 2-3 HR. DURATION OF EFFECT, 6-8 HR.
The Merck Index. 9th ed. Rahway, New Jersey: Merck & Co., Inc., 1976., p. 659
EVERY DIABETIC PATIENT TAKING INSULIN SHOULD CARRY AN IDENTIFICATION CARD CONTAINING PERTINENT MEDICAL INFORMATION.
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1519
PATIENTS WHO EXPERIENCE ATROPHY OF SC FAT AT SITE OF INJECTION (INSULIN LIPOATROPHY) SHOULD INJECT INSULIN IN AREAS THAT ARE USUALLY COVERED BY CLOTHING; PROBLEM MAY BE MINIMIZED BY CHANGING SITE OF INJECTION FREQUENTLY.
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1519
...SINCE SEVERAL WEEKS MAY BE REQUIRED TO STABILIZE OSMOTIC EQUILIBRIUM IN THE EYE, ALTERATIONS OF PRESCRIPTIONS FOR CORRECTIVE LENSES SHOULD BE POSTPONED FOR 3-6 WEEKS.
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1519
...DIABETIC PT RECEIVING THYROID HORMONE REPLACEMENT THERAPY SHOULD BE MONITORED FOR INCR INSULIN REQUIREMENTS. /MECHANISM OF ACTION ONLY THEORIZED/
Evaluations of Drug Interactions. 2nd ed. and supplements. Washington, DC: American Pharmaceutical Assn., 1976, 1978., p. 553
OVERDOSAGE CAN BE FATAL.
Hawley, G.G. The Condensed Chemical Dictionary. 9th ed. New York: Van Nostrand Reinhold Co., 1977., p. 468
Hypoglycemic Agents
Substances which lower blood glucose levels. (See all compounds classified as Hypoglycemic Agents.)
FRACTION OF...EXOGENOUS INSULIN IN PLASMA MAY BE ASSOC WITH CERTAIN PROTEINS, CHIEFLY ALPHA- & BETA-GLOBULINS. ...THESE ASSOC ARE OF IMPORTANCE FOR TRANSPORT OF INSULIN...WHICH APPEARS TO CIRCULATE IN BLOOD & LYMPH... VOL OF DISTRIBUTION OF INSULIN APPROXIMATES VOL OF EXTRACELLULAR FLUID.
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1511
WHILE INSULIN CAN BE DETECTED IN URINE, THE KIDNEY FILTERS & REABSORBS THE HORMONE & RENAL EXCRETION IS NOT MAJOR ROUTE OF ELIMINATION. LIVER & KIDNEY ARE OF PRIMARY IMPORTANCE IN DEGRADING HORMONE & EACH IS CAPABLE OF DESTROYING ALMOST 40% OF INSULIN PRODUCED PER DAY (30 TO 50 UNITS).
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1511
SEVERE IMPAIRMENT OF RENAL FUNCTION APPEARS TO AFFECT RATE OF DISAPPEARANCE OF CIRCULATING INSULIN TO GREATER EXTENT THAN DOES HEPATIC DISEASE...
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1511
IN ABSENCE OF INSULIN THERE IS MARKED REDUCTION IN RATE OF TRANSPORT OF GLUCOSE ACROSS CERTAIN CELL MEMBRANES.
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1512
SERIAL IMMUNOREACTIVE INSULIN CONCN WERE MUCH HIGHER AFTER EXERCISE THAN THOSE ASSOC WITH REST. THE ENHANCED ABSORPTION OF INSULIN FROM SC TISSUE IS PROBABLY THROUGH AN INCR IN BLOOD FLOW IN INJECTED LIMB.
DANDONA P ET AL; BR MED J 1 (FEB) 479-80 (1978)
IN-VITRO EXPT SUGGESTS 2 SYSTEMS INVOLVED IN DEGRADATION OF INSULIN BY LIVER: (1) ENZYME TERMED GLUTATHIONE-INSULIN TRANSHYDROGENASE, WHICH UTILIZES REDUCED GLUTATHIONE TO REDUCE DISULFIDE BRIDGES; & (2) PROTEOLYTIC ENZYME(S) THAT CLEAVES REDUCED & SEPARATED CHAINS TO PEPTIDES & AMINO ACIDS.
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1511
A PROTEOLYTIC ENZYME THAT DEGRADES BOTH INSULIN & GLUCAGON HAS BEEN EXTENSIVELY PURIFIED FROM RAT SKELETAL MUSCLE.
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1512
PLASMA HALF-LIFE OF INSULIN INJECTED INTRAVENOUSLY IS LESS THAN 9 MINUTES IN MAN.
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1511
INSULIN HAS DIRECT INHIBITORY EFFECT ON LIPASE CONCERNED WITH MOBILIZATION OF FATTY ACIDS, WHILE GROWTH HORMONE, GLUCOCORTICOIDS, THYROID HORMONES & CATECHOLAMINES ENHANCE LIPOLYSIS.
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1515
IN ABSENCE OF INSULIN THERE IS ABNORMALLY HIGH RATE OF CONVERSION OF PROTEIN TO GLUCOSE. ... PROTEINS & AMINO ACIDS ARE CONVERTED TO GLUCOSE @ ABNORMALLY HIGH RATE IN INSULIN DEFICIENCY. THE LIVER IS SITE OF CONVERSION. PROTEIN & AMINO ACIDS ARE MOBILIZED FROM PERIPHERAL TISSUES.
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1514
INSULIN ACTS TO.../STIMULATE/ GLYCOGEN SYNTHESIS.
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1515
MECHANISM OF IMPORTANT ACTIONS OF INSULIN TO ENHANCE FACILITATED DIFFUSION OF GLUCOSE & ACTIVE TRANSPORT OF AMINO ACIDS ARE NOT KNOWN.
Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1516
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28677
Submission : 2014-10-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34779
Submission : 2020-04-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2921
Submission : 1977-05-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27440
Submission : 2013-08-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3536
Submission : 1979-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3830
Submission : 1980-05-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5758
Submission : 1985-02-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13240
Submission : 1998-09-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16482
Submission : 2003-03-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13240
Submission : 1998-09-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2921
Submission : 1977-05-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1713
Submission : 1971-04-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28677
Submission : 2014-10-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16482
Submission : 2003-03-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3536
Submission : 1979-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5758
Submission : 1985-02-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3830
Submission : 1980-05-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27440
Submission : 2013-08-15
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2446
Submission : 1975-05-07
Status : Inactive
Type : II
Portfolio PDF
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Corporate PDF
NDC Package Code : 69098-101
Start Marketing Date : 2014-07-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69098-101
Start Marketing Date : 2014-07-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 82196-020
Start Marketing Date : 2024-12-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (28.5mg/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
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Details:
Under the agreement, Oramed will accelerate the development and commercialization of oral ORMD-0801 (insulin), which is being evaluated for the treatment of Type 2 Diabetes Mellitus.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Brand Name: ORMD-0801
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Hefei Tianhui Biotech
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 11, 2025
Lead Product(s) : Insulin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Hefei Tianhui Biotech
Deal Size : Undisclosed
Deal Type : Agreement
Oramed Forms Joint Venture to Advance Oral Insulin Development & Sales
Details : Under the agreement, Oramed will accelerate the development and commercialization of oral ORMD-0801 (insulin), which is being evaluated for the treatment of Type 2 Diabetes Mellitus.
Product Name : ORMD-0801
Product Type : Hormone
Upfront Cash : Undisclosed
February 11, 2025
Details:
The funding will support the pre-clinical development of ABV100, the Company’s initial proprietary insulin-glucagon combination candidate developing to treat diabetes.
Lead Product(s): Insulin,Glucagon
Therapeutic Area: Endocrinology Brand Name: ABV100
Study Phase: PreclinicalProduct Type: Hormone
Sponsor: Helmsley Charitable Trust
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Financing October 09, 2024
Lead Product(s) : Insulin,Glucagon
Therapeutic Area : Endocrinology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Helmsley Charitable Trust
Deal Size : Undisclosed
Deal Type : Financing
Abvance Gets $3.9M Investment from Helmsley Trust For Insulin-Glucagon Drug
Details : The funding will support the pre-clinical development of ABV100, the Company’s initial proprietary insulin-glucagon combination candidate developing to treat diabetes.
Product Name : ABV100
Product Type : Hormone
Upfront Cash : Undisclosed
October 09, 2024
Details:
The collaboration aims to develop a novel, high concentration, thermostable insulin for use by Medtronic’s Diabetes business in a next-generation implantable pump.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Hormone
Sponsor: Medtronic Plc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration September 05, 2024
Lead Product(s) : Insulin
Therapeutic Area : Endocrinology
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Medtronic Plc
Deal Size : Undisclosed
Deal Type : Collaboration
Arecor and Medtronic Collaborate to Develop Novel Thermostable Insulin for Pump Delivery
Details : The collaboration aims to develop a novel, high concentration, thermostable insulin for use by Medtronic’s Diabetes business in a next-generation implantable pump.
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Undisclosed
September 05, 2024
Details:
The insulin delivery technology company with the first FDA-cleared patch pump, designed specifically to target all adult "almost-pumpers," offers a user-friendly and affordable solution for obesity.
Lead Product(s): Insulin
Therapeutic Area: Nutrition and Weight Loss Brand Name: Undisclosed
Study Phase: PreclinicalProduct Type: Hormone
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 11, 2024
Lead Product(s) : Insulin
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Modular Medical Announces Results from a Successful GLP-1 Proof of Concept Study
Details : The insulin delivery technology company with the first FDA-cleared patch pump, designed specifically to target all adult "almost-pumpers," offers a user-friendly and affordable solution for obesity.
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Inapplicable
July 11, 2024
Details:
Insulin is a peptide based drug, which is indicated for the treatment of patients with type 1 and 2 diabetes.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Brand Name: Omnipod
Study Phase: Approved FDFProduct Type: Hormone
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 09, 2024
Lead Product(s) : Insulin
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Embecta Secures FDA Clearance for Insulin Patch Pump in Type 1 and Type 2 Diabetes
Details : Insulin is a peptide based drug, which is indicated for the treatment of patients with type 1 and 2 diabetes.
Product Name : Omnipod
Product Type : Hormone
Upfront Cash : Inapplicable
March 09, 2024
Details:
ORMD-0801 (oral insulin) Capsule, with enhanced patient compliance, is currently undergoing phase III clinical trials for the T2DM indication. Drug has the potential to delay the disease progression or even eliminating late-stage complications.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Brand Name: ORMD-0801
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 01, 2023
Lead Product(s) : Insulin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ORMD-0801 (oral insulin) Capsule, with enhanced patient compliance, is currently undergoing phase III clinical trials for the T2DM indication. Drug has the potential to delay the disease progression or even eliminating late-stage complications.
Product Name : ORMD-0801
Product Type : Hormone
Upfront Cash : Inapplicable
November 01, 2023
Details:
ORMD-0801 (oral insulin) capsule, with enhanced patient compliance, is currently undergoing phase III clinical trials for the T2DM indication. Drug has the potential to delay the disease progression or even eliminating late-stage complications.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Brand Name: ORMD-0801
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Oramed Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 15, 2023
Lead Product(s) : Insulin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Oramed Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ORMD-0801 (oral insulin) capsule, with enhanced patient compliance, is currently undergoing phase III clinical trials for the T2DM indication. Drug has the potential to delay the disease progression or even eliminating late-stage complications.
Product Name : ORMD-0801
Product Type : Hormone
Upfront Cash : Inapplicable
May 15, 2023
Details:
ORMD-0801 (Oral insulin) Capsule, with enhanced patient compliance, is currently undergoing phase III clinical trials for the T2DM indication. Drug has the potential to delay the disease progression or even eliminating late-stage complications.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Brand Name: ORMD-0801
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 01, 2023
Lead Product(s) : Insulin
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ORMD-0801 (Oral insulin) Capsule, with enhanced patient compliance, is currently undergoing phase III clinical trials for the T2DM indication. Drug has the potential to delay the disease progression or even eliminating late-stage complications.
Product Name : ORMD-0801
Product Type : Hormone
Upfront Cash : Inapplicable
April 01, 2023
Details:
The collaboration will focus on the integration of Novo Nordisk's new generation of connected pens, NovoPen® 6 and NovoPen Echo® Plus with DBL-4pen™. Diabeloop is planning a study for Type 2 diabetes to evaluate the efficacy and clinical benefits of the combined technologies.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Hormone
Sponsor: Novo Nordisk
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration March 21, 2023
Lead Product(s) : Insulin
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Novo Nordisk
Deal Size : Undisclosed
Deal Type : Collaboration
Details : The collaboration will focus on the integration of Novo Nordisk's new generation of connected pens, NovoPen® 6 and NovoPen Echo® Plus with DBL-4pen™. Diabeloop is planning a study for Type 2 diabetes to evaluate the efficacy and clinical benefits of ...
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Undisclosed
March 21, 2023
Details:
Under the agreement, Californians with diabetes will have access to Civica’s low-cost insulins via the CalRx Biosimilar Insulin Initiative. Civica will produce three insulins, glargine, lispro and aspart, available both in vials and prefilled pens under the CalRx label.
Lead Product(s): Insulin
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Hormone
Sponsor: CalRx Biosimilar Insulin Initiative
Deal Size: $50.0 million Upfront Cash: Undisclosed
Deal Type: Partnership March 18, 2023
Lead Product(s) : Insulin
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : CalRx Biosimilar Insulin Initiative
Deal Size : $50.0 million
Deal Type : Partnership
California Selects Civica Rx as Its Insulin Manufacturing Partner
Details : Under the agreement, Californians with diabetes will have access to Civica’s low-cost insulins via the CalRx Biosimilar Insulin Initiative. Civica will produce three insulins, glargine, lispro and aspart, available both in vials and prefilled pens unde...
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Undisclosed
March 18, 2023
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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 Insulinum humanum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Insulinum humanum, including repackagers and relabelers. The FDA regulates Insulinum humanum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Insulinum humanum 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 Insulinum humanum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Insulinum humanum supplier is an individual or a company that provides Insulinum humanum active pharmaceutical ingredient (API) or Insulinum humanum finished formulations upon request. The Insulinum humanum suppliers may include Insulinum humanum API manufacturers, exporters, distributors and traders.
click here to find a list of Insulinum humanum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Insulinum humanum DMF (Drug Master File) is a document detailing the whole manufacturing process of Insulinum humanum active pharmaceutical ingredient (API) in detail. Different forms of Insulinum humanum DMFs exist exist since differing nations have different regulations, such as Insulinum humanum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Insulinum humanum DMF submitted to regulatory agencies in the US is known as a USDMF. Insulinum humanum USDMF includes data on Insulinum humanum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Insulinum humanum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Insulinum humanum 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 Insulinum humanum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Insulinum humanum 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 Insulinum humanum 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 Insulinum humanum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Insulinum humanum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Insulinum humanum suppliers with NDC on PharmaCompass.
Insulinum humanum 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 Insulinum humanum 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 Insulinum humanum GMP manufacturer or Insulinum humanum GMP API supplier for your needs.
A Insulinum humanum CoA (Certificate of Analysis) is a formal document that attests to Insulinum humanum's compliance with Insulinum humanum specifications and serves as a tool for batch-level quality control.
Insulinum humanum CoA mostly includes findings from lab analyses of a specific batch. For each Insulinum humanum 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.
Insulinum humanum may be tested according to a variety of international standards, such as European Pharmacopoeia (Insulinum humanum EP), Insulinum humanum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Insulinum humanum USP).