Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
Australia
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
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
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
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 : 3830
Submission : 1980-05-30
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 : 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
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD :
TE Code :
Brand Name : MYXREDLIN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 100 UNITS/100ML (1 UNIT/ML)
Approval Date :
Application Number : 208157
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : HUMULIN R KWIKPEN
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 1500 UNITS/3ML (500 UNITS/ML)
Approval Date :
Application Number : 18780
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : HUMULIN R
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : 10000 UNITS/20ML (500 UNITS/ML)
Approval Date :
Application Number : 18780
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : LYUMJEV
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 100UNITS/ML(U-100)
Approval Date :
Application Number : 761109
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : LYUMJEV
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 200UNITS/ML(U-200)
Approval Date :
Application Number : 761109
RX/OTC/DISCN :
RLD :
TE Code :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Insulin Human Winthrop Basal
Dosage Form : SUSPENSION FOR INJECTION
Dosage Strength : 100 IU / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Insulin Human Winthrop Basal SoloStar
Dosage Form : SUSPENSION FOR INJECTION IN PRE-FILLED
Dosage Strength : 100 IU / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Insulin Human Winthrop Infusat
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 100 IU / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Insulin Human Winthrop Rapid
Dosage Form : SOLUTION FOR INJECTION IN CARTRIDGE
Dosage Strength : 100 IU / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Insulin Human Winthrop Rapid SoloStar
Dosage Form : SOLUTION FOR INJECTION IN PRE-FILLED
Dosage Strength : 100 IU / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Insuman Basal
Dosage Form : SUSPENSION FOR INJECTION
Dosage Strength : 40 IU / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Insuman Basal SoloStar
Dosage Form : SUSPENSION FOR INJECTION IN PRE-FILLED
Dosage Strength : 100 IU / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Insuman Rapid
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 40 IU / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Insuman Rapid
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 100 IU / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Insulin Human Winthrop Basal OptiSet
Dosage Form : SUSPENSION FOR INJECTION IN PRE-FILLED
Dosage Strength : 100 IU / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : PROZINC
Dosage Form : SUSPENSION
Dosage Strength : 40UNIT/ML
Packaging : 10ML
Approval Date :
Application Number : 2405202
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
INSULIN INJECTION HUMAN BIOSYNTHETIC
Brand Name : HUMULIN 30/70 CARTRIDGE
Dosage Form : SUSPENSION
Dosage Strength : 30UNIT/ML
Packaging : 3ML
Approval Date :
Application Number : 1959212
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
INSULIN ISOPHANE HUMAN BIOSYNTHETIC
Brand Name : HUMULIN 30/70 CARTRIDGE
Dosage Form : SUSPENSION
Dosage Strength : 70UNIT/ML
Packaging : 3ML
Approval Date :
Application Number : 1959212
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
INSULIN INJECTION HUMAN BIOSYNTHETIC
Brand Name : HUMULIN R CARTRIDGE
Dosage Form : SOLUTION
Dosage Strength : 100UNIT/ML
Packaging : 3 ML
Approval Date :
Application Number : 1959220
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
Brand Name : HUMULIN 30/70 (INSULIN HUMAN BIOSYNTH INJ)
Dosage Form : SUSPENSION
Dosage Strength : 30UNIT/ML
Packaging : 10ML
Approval Date :
Application Number : 795879
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
INSULIN ISOPHANE HUMAN BIOSYNTHETIC
Brand Name : HUMULIN N (KWIKPEN)
Dosage Form : SUSPENSION
Dosage Strength : 100UNIT/ML
Packaging : 3 ML
Approval Date :
Application Number : 2403447
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
INSULIN INJECTION HUMAN BIOSYNTHETIC
Brand Name : ENTUZITY KWIKPEN
Dosage Form : SOLUTION
Dosage Strength : 500UNIT/ML
Packaging : 3ML
Approval Date :
Application Number : 2466864
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
INSULIN ISOPHANE HUMAN BIOSYNTHETIC
Brand Name : NOVOLIN GE 30/70 PENFILL
Dosage Form : SUSPENSION
Dosage Strength : 70UNIT/ML
Packaging : 3ML
Approval Date :
Application Number : 2025248
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
INSULIN ISOPHANE HUMAN BIOSYNTHETIC
Brand Name : NOVOLIN GE NPH PENFILL
Dosage Form : SUSPENSION
Dosage Strength : 100UNIT/ML
Packaging : 3ML CARTRIDGE
Approval Date :
Application Number : 2024268
Regulatory Info : Schedule D
Registration Country : Canada
Regulatory Info : Schedule D
Registration Country : Canada
INSULIN INJECTION HUMAN BIOSYNTHETIC
Brand Name : NOVOLIN GE 30/70
Dosage Form : SUSPENSION
Dosage Strength : 30UNIT/ML
Packaging : 10ML
Approval Date :
Application Number : 2024217
Regulatory Info : Schedule D
Registration Country : Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Insuman Comb 30/70 (300 IU/3 ml)
Dosage Form : INJ
Dosage Strength : 300IU/3ml
Packaging : 3X5IU/3ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Actrapid HM (ge)
Dosage Form : INJ
Dosage Strength : 100u/ml
Packaging : 10X1u/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Actrapid HM (ge)
Dosage Form : PED
Dosage Strength : 100u/ml
Packaging : 3X5u/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Dossiers
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 400IU/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 400IU/10ML
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 300IU/3ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 300IU/3ML
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 400IU/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 400IU/10ML
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 300IU/3ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging :
Regulatory Info :
Dosage : Injection
Dosage Strength : 300IU/3ML
Brand Name :
Approval Date :
Application Number :
Registration Country : China
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Capital Farma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Parenteral
Solubilizers
Topical
Emulsifying Agents
Film Formers & Plasticizers
Thickeners and Stabilizers
Surfactant & Foaming Agents
Fillers, Diluents & Binders
Coating Systems & Additives
API Stability Enhancers
Controlled & Modified Release
Direct Compression
Co-Processed Excipients
Rheology Modifiers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
CLINICAL TRIALS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ANALYTICAL
Analytical Methods
ABOUT THIS PAGE
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 Afrezza manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Afrezza, including repackagers and relabelers. The FDA regulates Afrezza manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Afrezza 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 Afrezza manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Afrezza supplier is an individual or a company that provides Afrezza active pharmaceutical ingredient (API) or Afrezza finished formulations upon request. The Afrezza suppliers may include Afrezza API manufacturers, exporters, distributors and traders.
click here to find a list of Afrezza suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Afrezza DMF (Drug Master File) is a document detailing the whole manufacturing process of Afrezza active pharmaceutical ingredient (API) in detail. Different forms of Afrezza DMFs exist exist since differing nations have different regulations, such as Afrezza USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Afrezza DMF submitted to regulatory agencies in the US is known as a USDMF. Afrezza USDMF includes data on Afrezza's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Afrezza USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Afrezza 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 Afrezza as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Afrezza 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 Afrezza 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 Afrezza and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Afrezza NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Afrezza suppliers with NDC on PharmaCompass.
Afrezza 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 Afrezza 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 Afrezza GMP manufacturer or Afrezza GMP API supplier for your needs.
A Afrezza CoA (Certificate of Analysis) is a formal document that attests to Afrezza's compliance with Afrezza specifications and serves as a tool for batch-level quality control.
Afrezza CoA mostly includes findings from lab analyses of a specific batch. For each Afrezza 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.
Afrezza may be tested according to a variety of international standards, such as European Pharmacopoeia (Afrezza EP), Afrezza JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Afrezza USP).
