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    Chemistry

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    Also known as: 001, rad, 40-o-(2-hydroxyethyl)-rapamycin, 40-o-(2-hydroxyethyl)rapamycin, Afinitor, Certican, Rad
    Molecular Formula
    C53H83NO14
    Molecular Weight
    958.2  g/mol
    InChI Key
    HKVAMNSJSFKALM-GKUWKFKPSA-N
    FDA UNII
    9HW64Q8G6G
    Everolimus
    A derivative of sirolimus and an inhibitor of TOR SERINE-THREONINE KINASES. It is used to prevent GRAFT REJECTION in heart and kidney transplant patients by blocking cell proliferation signals. It is also an ANTINEOPLASTIC AGENT.
    Everolimus is a Kinase Inhibitor and mTOR Inhibitor Immunosuppressant. The mechanism of action of everolimus is as a Protein Kinase Inhibitor and Cytochrome P450 3A4 Inhibitor and Cytochrome P450 2D6 Inhibitor and mTOR Inhibitor. The physiologic effect of everolimus is by means of Decreased Immunologic Activity.
    1 2D Structure

    Everolimus

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-dihydroxy-12-[(2R)-1-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone
    2.1.2 InChI
    InChI=1S/C53H83NO14/c1-32-16-12-11-13-17-33(2)44(63-8)30-40-21-19-38(7)53(62,68-40)50(59)51(60)54-23-15-14-18-41(54)52(61)67-45(35(4)28-39-20-22-43(66-25-24-55)46(29-39)64-9)31-42(56)34(3)27-37(6)48(58)49(65-10)47(57)36(5)26-32/h11-13,16-17,27,32,34-36,38-41,43-46,48-49,55,58,62H,14-15,18-26,28-31H2,1-10H3/b13-11+,16-12+,33-17+,37-27+/t32-,34-,35-,36-,38-,39+,40+,41+,43-,44+,45+,46-,48-,49+,53-/m1/s1
    2.1.3 InChI Key
    HKVAMNSJSFKALM-GKUWKFKPSA-N
    2.1.4 Canonical SMILES
    CC1CCC2CC(C(=CC=CC=CC(CC(C(=O)C(C(C(=CC(C(=O)CC(OC(=O)C3CCCCN3C(=O)C(=O)C1(O2)O)C(C)CC4CCC(C(C4)OC)OCCO)C)C)O)OC)C)C)C)OC
    2.1.5 Isomeric SMILES
    C[C@@H]1CC[C@H]2C[C@@H](/C(=C/C=C/C=C/[C@H](C[C@H](C(=O)[C@@H]([C@@H](/C(=C/[C@H](C(=O)C[C@H](OC(=O)[C@@H]3CCCCN3C(=O)C(=O)[C@@]1(O2)O)[C@H](C)C[C@@H]4CC[C@H]([C@@H](C4)OC)OCCO)C)/C)O)OC)C)C)/C)OC
    2.2 Other Identifiers
    2.2.1 UNII
    9HW64Q8G6G
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 001, Rad

    2. 40-o-(2-hydroxyethyl)-rapamycin

    3. Afinitor

    4. Certican

    5. Rad 001

    6. Rad, Sdz

    7. Rad001

    8. Sdz Rad

    9. Sdz-rad

    10. Zortress

    2.3.2 Depositor-Supplied Synonyms

    1. 001, Rad

    2. 40-o-(2-hydroxyethyl)-rapamycin

    3. 40-o-(2-hydroxyethyl)rapamycin

    4. Afinitor

    5. Certican

    6. Rad

    7. Rad 001

    8. Rad, Sdz

    9. Rad001

    10. Sdz Rad

    11. Sdz-rad

    12. Zortress

    13. 159351-69-6

    14. Votubia

    15. 42-o-(2-hydroxyethyl)rapamycin

    16. Rad-001

    17. Afinitor Disperz

    18. Chebi:68478

    19. Rapamycin, 42-o-(2-hydroxyethyl)-

    20. 9hw64q8g6g

    21. Rad 666

    22. Rad-666

    23. Everolimus (inn)

    24. Ncgc00167512-01

    25. Everolimus (rad001)

    26. Everolimus [inn]

    27. (3s,6r,7e,9r,10r,12r,14s,15e,17e,19e,21s,23s,26r,27r,34as)-9,27-dihydroxy-3-{(2r)-1-[(1s,3r,4r)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl}-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-3h-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontine-1,5,11,28,29(4h,6h,31h)-pentone

    28. (1r,9s,12s,15r,16e,18r,19r,21r,23s,24e,26e,28e,30s,35r)-1,18-dihydroxy-12-{(2r)-1-[(1s,3r,4r)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]propan-2-yl}-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.0(4,9)]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone

    29. Everolimus [usan]

    30. Everolimusum

    31. Nsc733504

    32. Everolimus Solution

    33. Sdzrad

    34. Everolimus Solution, 1.0 Mg/ml In Acetonitrile

    35. Xience V

    36. Everolimus [mi]

    37. Everolimus - Rad001

    38. Everolimus [jan]

    39. Everolimus [vandf]

    40. Everolimus [mart.]

    41. Schembl4378

    42. Dsstox_cid_20599

    43. Dsstox_rid_79508

    44. Everolimus [usp-rs]

    45. Everolimus [who-dd]

    46. Nvp-rad001

    47. Unii-9hw64q8g6g

    48. Dsstox_gsid_40599

    49. Everolimus [ema Epar]

    50. Everolimus [usan:inn:ban]

    51. Nvp-rad-001

    52. Everolimus, Analytical Standard

    53. Gtpl5889

    54. Rad-001c

    55. Chembl1908360

    56. Dtxsid0040599

    57. Everolimus [orange Book]

    58. Hsdb 8255

    59. Everolimus [ep Monograph]

    60. Everolimus; Rad001; Sdz-rad

    61. 42-o-(2-hydroxyethyl)-rapamycin

    62. Ex-a2057

    63. Tox21_112510

    64. Bdbm50088378

    65. Akos015850977

    66. Zinc169677008

    67. Cs-0064

    68. Db01590

    69. (1r,9s,12s,15r,16e,18r,19r,21r,23s,24e,26e,28e,30s,32s,35r)-1,18-dihydroxy-12-((1r)-2-((1s,3r,4r)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl)-1-methylethyl)-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo(30.3.1.0(sup 4,9))hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone

    70. (1r,9s,12s,15r,16e,18r,19r,21r,23s,24e,26e,28e,30s,32s,35r)-1,18-dihydroxy-12-((1r)-2-((1s,3r,4r)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl)-1-methylethyl)-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo(30.3.1.04,9)hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentaone

    71. (3s,6r,7e,9r,10r,12r,14s,15e,17e,19e,21s,23s,26r,27r,34as)-9,10,12,13,14,21,22,23,24,25,26,27,32,33,34,34a-hexadecahydro-9,27-dihydroxy-3-((1r)-2-((1s,3r,4r)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl)-1-methylethyl)-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-23,27-epoxy-3h-pyrido(2,1-c)(1,4)oxaazacyclohentriacontine-1,5,11,28,29(4h,6h,31h)-pentone

    72. As-16971

    73. Hy-10218

    74. Cas-159351-69-6

    75. 351e696

    76. Q421052

    77. Q-101413

    78. Brd-k13514097-001-01-2

    79. Brd-k13514097-001-05-3

    80. Dihydroxy-[(1r)-2-[(1s,3r,4r)-4-(2-hydroxyethoxy)-3-methoxy-cyclohexyl]-1-methyl-ethyl]-dimethoxy-hexamethyl-[?]pentone

    81. Everolimus Solution, 1.0 Mg/ml In Acetonitrile, Ampule Of 1 Ml, Certified Reference Material

    2.4 Create Date
    2006-04-28
    3 Chemical and Physical Properties
    Molecular Weight 958.2 g/mol
    Molecular Formula C53H83NO14
    XLogP35.9
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count14
    Rotatable Bond Count9
    Exact Mass957.58135632 g/mol
    Monoisotopic Mass957.58135632 g/mol
    Topological Polar Surface Area205 Ų
    Heavy Atom Count68
    Formal Charge0
    Complexity1810
    Isotope Atom Count0
    Defined Atom Stereocenter Count15
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count4
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 4  
    Drug NameAfinitor
    PubMed HealthEverolimus (By mouth)
    Drug ClassesAntineoplastic Agent, Immune Suppressant
    Drug LabelAFINITOR (everolimus), an inhibitor of mammalian target of rapamycin (mTOR), is an antineoplastic agent.The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxy...
    Active IngredientEverolimus
    Dosage FormTablet
    RouteOral
    Strength2.5mg; 5mg; 7.5mg; 10mg
    Market StatusPrescription
    CompanyNovartis

    2 of 4  
    Drug NameZortress
    PubMed HealthEverolimus (By mouth)
    Drug ClassesAntineoplastic Agent, Immune Suppressant
    Drug LabelZortress (everolimus) is a macrolide immunosuppressant.The chemical name of everolimus is(1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-m...
    Active IngredientEverolimus
    Dosage FormTablet
    RouteOral
    Strength0.5mg; 0.25mg; 0.75mg
    Market StatusPrescription
    CompanyNovartis

    3 of 4  
    Drug NameAfinitor
    PubMed HealthEverolimus (By mouth)
    Drug ClassesAntineoplastic Agent, Immune Suppressant
    Drug LabelAFINITOR (everolimus), an inhibitor of mammalian target of rapamycin (mTOR), is an antineoplastic agent.The chemical name of everolimus is (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxy...
    Active IngredientEverolimus
    Dosage FormTablet
    RouteOral
    Strength2.5mg; 5mg; 7.5mg; 10mg
    Market StatusPrescription
    CompanyNovartis

    4 of 4  
    Drug NameZortress
    PubMed HealthEverolimus (By mouth)
    Drug ClassesAntineoplastic Agent, Immune Suppressant
    Drug LabelZortress (everolimus) is a macrolide immunosuppressant.The chemical name of everolimus is(1R, 9S, 12S, 15R, 16E, 18R, 19R, 21R, 23S, 24E, 26E, 28E, 30S, 32S, 35R)-1, 18-dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-m...
    Active IngredientEverolimus
    Dosage FormTablet
    RouteOral
    Strength0.5mg; 0.25mg; 0.75mg
    Market StatusPrescription
    CompanyNovartis

    4.2 Therapeutic Uses

    Immunosuppressive Agents

    National Library of Medicine's Medical Subject Headings. Everolimus. Online file (MeSH, 2015). Available from, as of May 1, 2015: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    /CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health(NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Everolimus is included in the database.

    NIH/NLM; ClinicalTrials.Gov. Available from, as of July 18, 2015: https://clinicaltrials.gov/search/intervention=Everolimus

    Afinitor is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Afinitor (Everolimus) Tablet; Afinitor Disperz (Everolimus) Tablet, For Suspension (Updated: January 2015). Available from, as of May 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2150f73a-179b-4afc-b8ce-67c85cc72f04

    Afinitor Tablets and Afinitor Disperz are indicated in pediatric and adult patients with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. /Included in US product label/c

    NIH; DailyMed. Current Medication Information for Afinitor (Everolimus) Tablet; Afinitor Disperz (Everolimus) Tablet, For Suspension (Updated: January 2015). Available from, as of May 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2150f73a-179b-4afc-b8ce-67c85cc72f04

    For more Therapeutic Uses (Complete) data for EVEROLIMUS (9 total), please visit the HSDB record page.

    4.3 Drug Warning

    /BOXED WARNING/ WARNING: MALIGNANCIES AND SERIOUS INFECTIONS. Only physicians experienced in immunosuppressive therapy and management of transplant patients should prescribe Zortress. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient. Increased susceptibility to infection and the possible development of malignancies such as lymphoma and skin cancer may result from immunosuppression.

    NIH; DailyMed. Current Medication Information for Zortress (Everolimus) Tablet (Updated: January 2015). Available from, as of May 19, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e082a024-7850-400b-a5c2-2a140612562a

    /BOXED WARNING/ WARNING: KIDNEY GRAFT THROMBOSIS. An increased risk of kidney arterial and venous thrombosis, resulting in graft loss, was reported, mostly within the first 30 days post-transplantation.

    NIH; DailyMed. Current Medication Information for Zortress (Everolimus) Tablet (Updated: January 2015). Available from, as of May 19, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e082a024-7850-400b-a5c2-2a140612562a

    /BOXED WARNING/ WARNING: NEPHROTOXICITY. Increased nephrotoxicity can occur with use of standard doses of cyclosporine in combination with Zortress. Therefore reduced doses of cyclosporine should be used in combination with Zortress in order to reduce renal dysfunction. It is important to monitor the cyclosporine and everolimus whole blood trough concentrations.

    NIH; DailyMed. Current Medication Information for Zortress (Everolimus) Tablet (Updated: January 2015). Available from, as of May 19, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e082a024-7850-400b-a5c2-2a140612562a

    /BOXED WARNING/ WARNING: MORTALITY IN HEART TRANSPLANTATION. Increased mortality, often associated with serious infections, within the first three months post-transplantation was observed in a clinical trial of de novo heart transplant patients receiving immunosuppressive regimens with or without induction therapy. Use in heart transplantation is not recommended.

    NIH; DailyMed. Current Medication Information for Zortress (Everolimus) Tablet (Updated: January 2015). Available from, as of May 19, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e082a024-7850-400b-a5c2-2a140612562a

    For more Drug Warnings (Complete) data for EVEROLIMUS (32 total), please visit the HSDB record page.

    4.4 Drug Indication

    Everolimus is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole. Indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease. Indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. Indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. Indicated in pediatric and adult patients with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.

    FDA Label

    * Hormone-receptor-positive advanced breast:

    * cancer :

    Afinitor is indicated for the treatment of hormone-receptor-positive, HER2/neu-negative advanced breast cancer , in combination with exemestane, in post-menopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor.

    * Neuroendocrine tumours of pancreatic origin:

    Afinitor is indicated for the treatment of unresectable or metastatic, well or moderately differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease.

    * Neuroendocrine tumours of gastrointestinal or lung origin:

    Afinitor is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease.

    * Renal-cell carcinoma:

    Afinitor is indicated for the treatment of patients with advanced renal-cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.

    * Renal angiomyolipoma associated with tuberous sclerosis complex (TSC):

    Votubia is indicated for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumour size or presence of aneurysm, or presence of multiple or bilateral tumours) but who do not require immediate surgery.

    The evidence is based on analysis of change in sum of angiomyolipoma volume.

    * Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC):

    Votubia is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who require therapeutic intervention but are not amenable to surgery.

    The evidence is based on analysis of change in SEGA volume. Further clinical benefit, such as improvement in diseaserelated symptoms, has not been demonstrated.

    Treatment of tuberous sclerosis complex

    Treatment of thoracic neuroendocrine tumour

    Carcinoid tumours

    Prevention of rejection of transplanted liver, Prevention of rejection of transplanted heart, Prevention of rejection of transplanted kidney

    Treatment of angiomyolipoma, Treatment of subependymal giant-cell astrocytoma

    Renal cell carcinoma and pancreatic neuroendocrine tumour

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Immunosuppressive Agents

    Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)

    MTOR Inhibitors

    Agents that inhibit the activity of TOR SERINE-THREONINE KINASES. (See all compounds classified as MTOR Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    EVEROLIMUS
    5.2.2 FDA UNII
    9HW64Q8G6G
    5.2.3 Pharmacological Classes
    Cytochrome P450 3A4 Inhibitors [MoA]; Decreased Immunologic Activity [PE]; Kinase Inhibitor [EPC]; P-Glycoprotein Inhibitors [MoA]; Protein Kinase Inhibitors [MoA]; mTOR Inhibitor Immunosuppressant [EPC]; mTOR Inhibitors [MoA]; Cytochrome P450 2D6 Inhibitors [MoA]
    5.3 ATC Code

    L01XE10

    L01XE10

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01E - Protein kinase inhibitors

    L01EG - Mammalian target of rapamycin (mtor) kinase inhibitors

    L01EG02 - Everolimus

    L - Antineoplastic and immunomodulating agents

    L04 - Immunosuppressants

    L04A - Immunosuppressants

    L04AA - Selective immunosuppressants

    L04AA18 - Everolimus

    5.4 Absorption, Distribution and Excretion

    Absorption

    In patients with advanced solid tumors, peak everolimus concentrations are reached 1 to 2 hours after administration of oral doses ranging from 5 mg to 70 mg. Following single doses, Cmax is dose-proportional between 5 mg and 10 mg. At doses of 20 mg and higher, the increase in Cmax is less than dose-proportional, however AUC shows dose-proportionality over the 5 mg to 70 mg dose range. Steady-state was achieved within 2 weeks following once-daily dosing. Dose Proportionality in Patients with SEGA (subependymal giant-cell astrocytomas) and TSC (tuberous sclerosis complex): In patients with SEGA and TSC, everolimus Cmin was approximately dose-proportional within the dose range from 1.35 mg/m2 to 14.4 mg/m2.

    Route of Elimination

    After a single dose of radiolabeled everolimus was given to transplant patients receiving cyclosporine, the majority (80%) of radioactivity was recovered from the feces and only a minor amount (5%) was excreted in urine.

    Volume of Distribution

    The blood-to-plasma ratio of everolimus is 17% to 73%.

    Clearance

    Following a 3 mg radiolabeled dose of everolimus, 80% of the radioactivity was recovered from the feces, while 5% was excreted in the urine.

    The blood-to-plasma ratio of everolimus is concentration dependent ranging from 17% to 73% over the range of 5 ng/mL to 5000 ng/mL. Plasma protein binding is approximately 74% in healthy subjects and in patients with moderate hepatic impairment. The apparent distribution volume associated with the terminal phase (Vz/F) from a single-dose pharmacokinetic study in maintenance kidney transplant patients is 342 to 107 L (range 128 to 589 L).

    NIH; DailyMed. Current Medication Information for Zortress (Everolimus) Tablet (Updated: January 2015). Available from, as of May 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e082a024-7850-400b-a5c2-2a140612562a

    The blood-to-plasma ratio of everolimus, which is concentration-dependent over the range of 5 to 5000 ng/mL, is 17% to 73%. The amount of everolimus confined to the plasma is approximately 20% at blood concentrations observed in cancer patients given Afinitor 10 mg/day. Plasma protein binding is approximately 74% both in healthy subjects and in patients with moderate hepatic impairment.

    NIH; DailyMed. Current Medication Information for Afinitor (Everolimus) Tablet; Afinitor Disperz (Everolimus) Tablet, For Suspension (Updated: January 2015). Available from, as of May 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2150f73a-179b-4afc-b8ce-67c85cc72f04

    After administration of Afinitor tablets in patients with advanced solid tumors, peak everolimus concentrations are reached 1 to 2 hours after administration of oral doses ranging from 5 mg to 70 mg. Following single doses, Cmax is dose-proportional with daily dosing between 5 mg and 10 mg. With single doses of 20 mg and higher, the increase in Cmax is less than dose-proportional, however AUC shows dose-proportionality over the 5 mg to 70 mg dose range. Steady-state was achieved within 2 weeks following once-daily dosing.

    NIH; DailyMed. Current Medication Information for Afinitor (Everolimus) Tablet; Afinitor Disperz (Everolimus) Tablet, For Suspension (Updated: January 2015). Available from, as of May 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2150f73a-179b-4afc-b8ce-67c85cc72f04

    No specific elimination studies have been undertaken in cancer patients. Following the administration of a 3 mg single dose of radiolabeled everolimus in patients who were receiving cyclosporine, 80% of the radioactivity was recovered from the feces, while 5% was excreted in the urine. The parent substance was not detected in urine or feces. The mean elimination half-life of everolimus is approximately 30 hours.

    NIH; DailyMed. Current Medication Information for Afinitor (Everolimus) Tablet; Afinitor Disperz (Everolimus) Tablet, For Suspension (Updated: January 2015). Available from, as of May 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2150f73a-179b-4afc-b8ce-67c85cc72f04

    For more Absorption, Distribution and Excretion (Complete) data for EVEROLIMUS (7 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    Everolimus is a substrate of CYP3A4 and PgP (phosphoglycolate phosphatase). Three monohydroxylated metabolites, two hydrolytic ring-opened products, and a phosphatidylcholine conjugate of everolimus were the 6 primary metabolites detected in human blood. In vitro, everolimus competitively inhibited the metabolism of CYP3A4 and was a mixed inhibitor of the CYP2D6 substrate dextromethorphan.

    Everolimus is a substrate of CYP3A4 and PgP. Following oral administration, everolimus is the main circulating component in human blood. Six main metabolites of everolimus have been detected in human blood, including three monohydroxylated metabolites, two hydrolytic ring-opened products, and a phosphatidylcholine conjugate of everolimus. These metabolites were also identified in animal species used in toxicity studies, and showed approximately 100-times less activity than everolimus itself.

    NIH; DailyMed. Current Medication Information for Afinitor (Everolimus) Tablet; Afinitor Disperz (Everolimus) Tablet, For Suspension (Updated: January 2015). Available from, as of May 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2150f73a-179b-4afc-b8ce-67c85cc72f04

    Everolimus has known human metabolites that include (1R,9S,12S,15R,16Z,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18-Dihydroxy-12-[(2R)-1-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]propan-2-yl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone and (1R,9S,12S,15R,16Z,18R,19R,21R,23S,24E,30S,32S,35R)-1,18-dihydroxy-12-[(2R)-1-[(1S,3R,4R)-3-hydroxy-4-(2-hydroxyethoxy)cyclohexyl]propan-2-yl]-19,30-dimethoxy-15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-azatricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20-pentone.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.6 Biological Half-Life

    ~30 hours.

    The mean elimination half-life of everolimus is approximately 30 hours.

    NIH; DailyMed. Current Medication Information for Afinitor (Everolimus) Tablet; Afinitor Disperz (Everolimus) Tablet, For Suspension (Updated: January 2015). Available from, as of May 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2150f73a-179b-4afc-b8ce-67c85cc72f04

    5.7 Mechanism of Action

    Everolimus is a mTOR inhibitor that binds with high affinity to the FK506 binding protein-12 (FKBP-12), thereby forming a drug complex that inhibits the activation of mTOR. This inhibition reduces the activity of effectors downstream, which leads to a blockage in the progression of cells from G1 into S phase, and subsequently inducing cell growth arrest and apoptosis. Everolimus also inhibits the expression of hypoxia-inducible factor, leading to a decrease in the expression of vascular endothelial growth factor. The result of everolimus inhibition of mTOR is a reduction in cell proliferation, angiogenesis, and glucose uptake.

    Mechanistic target of rapamycin (mTOR) is a serine-threonine kinase that functions via two multiprotein complexes, namely mTORC1 and mTORC2, each characterized by different binding partners that confer separate functions. mTORC1 function is tightly regulated by PI3-K/Akt and is sensitive to rapamycin. mTORC2 is sensitive to growth factors, not nutrients, and is associated with rapamycin-insensitivity. mTORC1 regulates protein synthesis and cell growth through downstream molecules: 4E-BP1 (also called EIF4E-BP1) and S6K. Also, mTORC2 is thought to modulate growth factor signaling by phosphorylating the C-terminal hydrophobic motif of some AGC kinases such as Akt and SGK. Recent evidence has suggested that mTORC2 may play an important role in maintenance of normal as well as cancer cells by virtue of its association with ribosomes, which may be involved in metabolic regulation of the cell. Rapamycin (sirolimus) and its analogs known as rapalogues, such as RAD001 (everolimus) and CCI-779 (temsirolimus), suppress mTOR activity through an allosteric mechanism that acts at a distance from the ATP-catalytic binding site, and are considered incomplete inhibitors. Moreover, these compounds suppress mTORC1-mediated S6K activation, thereby blocking a negative feedback loop, leading to activation of mitogenic pathways promoting cell survival and growth. Consequently, mTOR is a suitable target of therapy in cancer treatments. However, neither of these complexes is fully inhibited by the allosteric inhibitor rapamycin or its analogs. In recent years, new pharmacologic agents have been developed which can inhibit these complexes via ATP-binding mechanism, or dual inhibition of the canonical PI3-K/Akt/mTOR signaling pathway. These compounds include WYE-354, KU-003679, PI-103, Torin1, and Torin2, which can target both complexes or serve as a dual inhibitor for PI3-K/mTOR. This investigation describes the mechanism of action of pharmacological agents that effectively target mTORC1 and mTORC2 resulting in suppression of growth, proliferation, and migration of tumor and cancer stem cells.

    PMID:25442674 Jhanwar-Uniyal M et al; Adv Biol Regul 57: 64-74 (2015)

    Mammalian target of rapamycin (mTOR) inhibitors have anti-tumor effects against renal cell carcinoma, pancreatic neuroendocrine cancer and breast cancer. In this study, we analyzed the antitumor effects of mTOR inhibitors in small cell lung cancer (SCLC) cells and sought to clarify the mechanism of resistance to mTOR inhibitors. We analyzed the antitumor effects of three mTOR inhibitors including everolimus in 7 SCLC cell lines by MTS assay. Gene-chip analysis, receptor tyrosine kinases (RTK) array and Western blotting analysis were performed to identify molecules associated with resistance to everolimus. Only SBC5 cells showed sensitivity to everolimus by MTS assay. We established two everolimus resistant-SBC5 cell lines (SBC5 R1 and SBC5 R10) by continuous exposure to increasing concentrations of everolimus stepwise. SPP1 and MYC were overexpressed in both SBC5 R1 and SBC5 R10 by gene-chip analysis. High expression levels of eukaryotic translation initiation factor 4E (eIF4E) were observed in 5 everolimus-resistant SCLC cells and SBC5 R10 cells by Western blotting. MYC siRNA reduced eIF4E phosphorylation in SBC5 cells, suggesting that MYC directly activates eIF4E by an mTOR-independent bypass pathway. Importantly, after reduction of MYC or eIF4E by siRNAs, the SBC5 parent and two SBC5-resistant cells displayed increased sensitivity to everolimus relative to the siRNA controls. These findings suggest that eIF4E has been shown to be an important factor in the resistance to everolimus in SCLC cells. Furthermore, a link between MYC and mTOR-independent eIF4E contribute to the resistance to everolimus in SCLC cells. Control of the MYC-eIF4E axis may be a novel therapeutic strategy for everolimus action in SCLC.

    PMID:25884680 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4414307 Matsumoto M et al; BMC Cancer. 2015 Apr 9;15:241. doi: 10.1186/s12885-015-1202-4

    Everolimus inhibits antigenic and interleukin (IL-2 and IL-15) stimulated activation and proliferation of T and B lymphocytes. In cells, everolimus binds to a cytoplasmic protein, the FK506 Binding Protein-12 (FKBP-12), to form an immunosuppressive complex (everolimus: FKBP-12) that binds to and inhibits the mammalian Target Of Rapamycin (mTOR), a key regulatory kinase. In the presence of everolimus phosphorylation of p70 S6 ribosomal protein kinase (p70S6K), a substrate of mTOR, is inhibited. Consequently, phosphorylation of the ribosomal S6 protein and subsequent protein synthesis and cell proliferation are inhibited. The everolimus: FKBP-12 complex has no effect on calcineurin activity. In rats and nonhuman primate models, everolimus effectively reduces kidney allograft rejection resulting in prolonged graft survival.

    NIH; DailyMed. Current Medication Information for Zortress (Everolimus) Tablet (Updated: January 2015). Available from, as of May 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e082a024-7850-400b-a5c2-2a140612562a

    Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine-threonine kinase, downstream of the PI3K/AKT pathway. The mTOR pathway is dysregulated in several human cancers. Everolimus binds to an intracellular protein, FKBP-12, resulting in an inhibitory complex formation with mTOR complex 1 (mTORC1) and thus inhibition of mTOR kinase activity. Everolimus reduced the activity of S6 ribosomal protein kinase (S6K1) and eukaryotic initiation factor 4E-binding protein (4E-BP1), downstream effectors of mTOR, involved in protein synthesis. S6K1 is a substrate of mTORC1 and phosphorylates the activation domain 1 of the estrogen receptor which results in ligand-independent activation of the receptor. In addition, everolimus inhibited the expression of hypoxia-inducible factor (e.g., HIF-1) and reduced the expression of vascular endothelial growth factor (VEGF). Inhibition of mTOR by everolimus has been shown to reduce cell proliferation, angiogenesis, and glucose uptake in in vitro and/or in vivo studies. Constitutive activation of the PI3K/Akt/mTOR pathway can contribute to endocrine resistance in breast cancer. In vitro studies show that estrogen-dependent and HER2+ breast cancer cells are sensitive to the inhibitory effects of everolimus, and that combination treatment with everolimus and Akt, HER2, or aromatase inhibitors enhances the anti-tumor activity of everolimus in a synergistic manner. Two regulators of mTORC1 signaling are the oncogene suppressors tuberin-sclerosis complexes 1 and 2 (TSC1, TSC2). Loss or inactivation of either TSC1 or TSC2 leads to activation of downstream signaling. In TSC, a genetic disorder, inactivating mutations in either the TSC1 or the TSC2 gene lead to hamartoma formation throughout the body.

    NIH; DailyMed. Current Medication Information for Afinitor (Everolimus) Tablet; Afinitor Disperz (Everolimus) Tablet, For Suspension (Updated: January 2015). Available from, as of May 4, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2150f73a-179b-4afc-b8ce-67c85cc72f04

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    BIOCON LIMITED Bengaluru IN

    India
    Health 2.0 Conference
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    BIOCON LIMITED Bengaluru IN

    India
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    Everolimus, 0.2% BHT

    Certificate Number : R0-CEP 2019-323 - Rev 00

    Status : Valid

    Issue Date : 2022-01-31

    Type : Chemical

    Substance Number : 2918

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    BRIGHTGENE BIO-MEDICAL TECHNOLOGY C...

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    Everolimus, Butylated hydroxytoluene 2.0%

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    CEP 2022-367 - Rev 00
    Valid
    Chemical
    2024-02-15
    2918
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    BRIGHTGENE BIO-MEDICAL TECHNOLOGY C...

    China
    Health 2.0 Conference
    Not Confirmed
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    CKD BIO CORPORATION Sapgyo-eup KR

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    Everolimus, 2.0% BHT

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    CEP 2019-321 - Rev 01
    Valid
    Chemical
    2023-11-30
    2918
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    08

    CKD BIO CORPORATION Sapgyo-eup KR

    South Korea
    Health 2.0 Conference
    Not Confirmed
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    CKD BIO CORPORATION Sapgyo-eup KR

    South Korea
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    Everolimus, 2.0% BHT

    Certificate Number : CEP 2019-321 - Rev 01

    Status : Valid

    Issue Date : 2023-11-30

    Type : Chemical

    Substance Number : 2918

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    CONCORD BIOTECH LIMITED Ahmedabad I...

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    Everolimus, with 2% BHT

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    CEP 2022-106 - Rev 01
    Valid
    Chemical
    2025-09-04
    2918
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    CONCORD BIOTECH LIMITED Ahmedabad I...

    India
    Health 2.0 Conference
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    CONCORD BIOTECH LIMITED Ahmedabad I...

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    Everolimus, With 2% BHT

    Certificate Number : CEP 2022-106 - Rev 01

    Status : Valid

    Issue Date : 2025-09-04

    Type : Chemical

    Substance Number : 2918

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    FARMHISPANIA S.A. Montmeló ES

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    Everolimus, 2.0% BHT - PROCESS II

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    CEP 2024-548 - Rev 00
    Valid
    Chemical
    2025-06-11
    2918
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    10

    FARMHISPANIA S.A. Montmeló ES

    Spain
    Health 2.0 Conference
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    JDMF

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    01

    Biocon Limited

    India
    IPhEB Russia
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    Biocon Limited

    India
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    IPhEB Russia
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    Everolimus (0.2% BHT)

    Registration Number : 307MF10060

    Registrant's Address : 20th KM Hosur Road, Electronics City, Bengaluru-560 100, Karnataka, India.

    Initial Date of Registration : 2025-05-14

    Latest Date of Registration : 2025-05-14

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    EU WC

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    01

    Biocon

    India
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    Biocon

    India
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    IPhEB Russia
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    Everolimus IH/Ph.Eur

    Date of Issue : 2025-08-19

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0100

    Address of the Firm : Special Economic Zone, Plot No. 2, 3, 4 & 5, Phase IV, Bommasandra-Jigani Link R...

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    02

    Biocon

    India
    IPhEB Russia
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    Biocon

    India
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    Everolimus

    Date of Issue : 2020-08-17

    Valid Till : 2022-02-07

    Written Confirmation Number : WC-0100a7

    Address of the Firm : Special Economic Zone, Plot No. 2, 3, 4 & 5, Phase IV, Bommasandra-Jigani Link R...

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    03

    Concord Biotech

    India
    IPhEB Russia
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    Concord Biotech

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    IPhEB Russia
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    Everolimus Premix 2%, Everolimus Premix 9.09% IH

    Date of Issue : 2025-11-04

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0111

    Address of the Firm : Survay No. 1482-1486, Trasad Road, Dholka, Dist:- Ahmedabad-382225, Gujarat Stat...

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    04

    Concord Biotech

    India
    IPhEB Russia
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    Concord Biotech

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    Everolimus IH/USP/EP

    Date of Issue : 2025-11-04

    Valid Till : 2028-07-02

    Written Confirmation Number : WC-0111

    Address of the Firm : Survay No. 1482-1486, Trasad Road, Dholka, Dist:- Ahmedabad-382225, Gujarat Stat...

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    Natco Pharma

    India
    IPhEB Russia
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    Natco Pharma

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    Everolimus IH/USP

    Date of Issue : 2025-09-12

    Valid Till : 2028-12-06

    Written Confirmation Number : WC-0372n

    Address of the Firm : S.No.73/1A, 74/7B, 78/1 B, 79/1, 2B, 3, 4B, 5, 6A, 6B, 7, 80/1, 2, 3, 4, 84/1, 2...

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    KDMF

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    01

    Biocon

    India
    Health 2.0 Conference
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    Biocon

    India
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    Everolimus

    Registrant Name : CTC Bio Co., Ltd.

    Registration Date : 2019-09-30

    Registration Number : Number 30-2-ND(2)

    Manufacturer Name : Biocon Limited

    Manufacturer Address : Plot No. 2, 3, 4 & 5 Phase-IV, Bommasandra-Jigani Link Road, Bommasandra Post, Bengal...

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    02

    Biocon

    India
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    Biocon

    India
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    Everolimus

    Registrant Name : Kwangdong Pharmaceutical Co., Ltd.

    Registration Date : 2018-09-13

    Registration Number : Number 30-2-ND(1)

    Manufacturer Name : Biocon Limited

    Manufacturer Address : Plot No. 2,3,4 & 5, Phase-IV, Bommasandra Jigani Link Road, Bommasandra Post Bengalur...

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    03

    Biocon

    India
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    Biocon

    India
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    Everolimus

    Registrant Name : Hiple Co., Ltd.

    Registration Date : 2018-09-12

    Registration Number : Su30-2-ND

    Manufacturer Name : Biocon Limited

    Manufacturer Address : Plot No. 2,3,4 & 5, Phase-IV, Bommasandra Jigani Link Road, Bommasandra Post Bengalur...

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    04

    BrightGene Bio-Medical Technology C...

    China
    Health 2.0 Conference
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    BrightGene Bio-Medical Technology C...

    China
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    Everolimus

    Registrant Name : Otran Pharm Korea Co., Ltd.

    Registration Date : 2020-08-06

    Registration Number : Su695-3-ND

    Manufacturer Name : BrightGene Pharmaceutical Co...

    Manufacturer Address : Building C25-C28, No.218 Xinghu Road, Suzhou Industrial Park, Suzhou, Jiangsu, China@...

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    05

    CKD Bio Corporation

    South Korea
    Health 2.0 Conference
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    CKD Bio Corporation

    South Korea
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    Everolimus

    Registrant Name : Chong Kun Dang Bio Co., Ltd.

    Registration Date : 2020-07-07

    Registration Number : 2253-5-ND

    Manufacturer Name : Chong Kun Dang Bio Co., Ltd....

    Manufacturer Address : Room 101, Buildings 2-1, 3-1, and 4, 226, Sandan 3-gil, Sapgyo-eup, Yesan-gun, Chungc...

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    06

    CKD Bio Corporation

    South Korea
    Health 2.0 Conference
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    South Korea
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    Everolimus

    Registrant Name : Chong Kun Dang Bio Co., Ltd.

    Registration Date : 2019-01-21

    Registration Number : 2253-4-ND

    Manufacturer Name : Chong Kun Dang Biotech Co., ...

    Manufacturer Address : Room 101, Buildings 2-1, 3-1, and 4, 226, Sandan 3-gil, Sapgyo-eup, Yesan-gun, Chungc...

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    07

    Concord Biotech

    India
    Health 2.0 Conference
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    Concord Biotech

    India
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    Everolimus

    Registrant Name : Seongyi Bio Co., Ltd.

    Registration Date : 2020-07-21

    Registration Number : Su259-9-ND

    Manufacturer Name : Concord Biotech Limited

    Manufacturer Address : Plot No. 1482-1486, Trasad Road, Dholka, District-Ahmedabad, India

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    08

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    Health 2.0 Conference
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    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Everolimus

    Registrant Name : Novartis Korea

    Registration Date : 2005-09-08

    Registration Number : Su163-2-ND

    Manufacturer Name : [Partial Contract Manufactur...

    Manufacturer Address : [Partial Contract Manufacturing (Client)](Synthesis and Blending Process)Lichtstrasse...

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    Novartis Pharmaceuticals Corporatio...

    Switzerland
    Health 2.0 Conference
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    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Everolimus

    Registrant Name : Novartis Korea

    Registration Date : 2016-09-19

    Registration Number : Su196-14-ND

    Manufacturer Name : Novartis Pharmaceutical Manu...

    Manufacturer Address : Kolodvorska cesta 27, Menges, 1234, Slovenia@Lichtstrasse 35, CH-4056 Basel, Switzerl...

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    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    Novartis Pharmaceuticals Corporatio...

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    Everolimus

    Registrant Name : Novartis Korea

    Registration Date : 2012-10-16

    Registration Number : Su163-11-ND

    Manufacturer Name : Novartis Pharma Schweizerhal...

    Manufacturer Address : Rothausstrasse, 4133 Pratteln, Switzerland @ [Partially contract manufacturing (Manuf...

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    NDC API

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    Chunghwa Chemical Synthesis & Biote...

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    EVEROLIMUS

    NDC Package Code : 52076-6253

    Start Marketing Date : 2018-01-09

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Chunghwa Chemical Synthesis & Biote...

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    EVEROLIMUS

    NDC Package Code : 52076-6247

    Start Marketing Date : 2018-01-10

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Chunghwa Chemical Sysnthsis & Biote...

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    EVEROLIMUS

    NDC Package Code : 52076-6270

    Start Marketing Date : 2021-02-02

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Chunghwa Chemical Synthesis & Biote...

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    EVEROLIMUS

    NDC Package Code : 52076-6234

    Start Marketing Date : 2018-01-11

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

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    05

    Biocon limited

    India
    IPhEB Russia
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    Biocon limited

    India
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    IPhEB Russia
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    EVEROLIMUS

    NDC Package Code : 65727-064

    Start Marketing Date : 2015-10-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    06

    Biocon Limited

    India
    IPhEB Russia
    Not Confirmed
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    Biocon Limited

    India
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    IPhEB Russia
    Not Confirmed
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    EVEROLIMUS

    NDC Package Code : 65727-063

    Start Marketing Date : 2015-09-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    07

    CONCORD BIOTECH LTD

    India
    IPhEB Russia
    Not Confirmed
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    CONCORD BIOTECH LTD

    India
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    IPhEB Russia
    Not Confirmed
    • fda
    • EDQM
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    EVEROLIMUS

    NDC Package Code : 68254-6234

    Start Marketing Date : 2011-08-01

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    08

    MSN Laboratories Private Limited

    India
    IPhEB Russia
    Not Confirmed
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    MSN Laboratories Private Limited

    India
    arrow
    IPhEB Russia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    EVEROLIMUS

    NDC Package Code : 54893-0126

    Start Marketing Date : 2024-03-26

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    09

    NATCO PHARMA LIMITED

    India
    IPhEB Russia
    Not Confirmed
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    NATCO PHARMA LIMITED

    India
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    IPhEB Russia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    EVEROLIMUS

    NDC Package Code : 70225-1103

    Start Marketing Date : 2015-11-19

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    10

    Novartis Pharmaceuticals Corporatio...

    Switzerland
    IPhEB Russia
    Not Confirmed
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    Novartis Pharmaceuticals Corporatio...

    Switzerland
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    IPhEB Russia
    Not Confirmed
    • fda
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    EVEROLIMUS

    NDC Package Code : 0078-1406

    Start Marketing Date : 2009-03-31

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Listed Suppliers

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    01

    LGM Pharma

    U.S.A
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    Interphex
    Booth #2158
    • fda
    • EDQM
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    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Everolimus

    About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...

    LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulation, analytical method development and testing, custom API synthesis, regulatory support, and commercial manufacturing. Supported by a network of over 300 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    LGM Pharma CB

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    02

    Chunghwa Chemical Synthesis & Biote...

    Taiwan
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    CPhI China
    Exhibiting
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    Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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    Everolimus

    About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers cost-effective APIs with speed, supported by a skilled team. As the first Southeast Asian company to receive FDA approv...

    Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers cost-effective APIs with speed, supported by a skilled team. As the first Southeast Asian company to receive FDA approval for synthetic and biotech APIs, CCSB has commercialized Statin, Immunosuppressant, Muscle Relaxant, and ACE Inhibitor APIs with complete DMF or COS. It partners with leading drug companies to develop and produce specialty APIs using advanced fermentation and synthesis technologies in Taiwan. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    CCSB Company Banner

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    03

    Sumar Biotech

    India
    arrow
    IPhEB Russia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSumar Biotech work together to Innovate & Manufacture Semi-synthetic, Synthetic & Fermentation API.

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    Everolimus

    About the Company : Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. Founded by young entrepreneurs and experienced research and manufac...

    Sumar Biotech LLP, registered in January 2018, is a startup approved by the Gujarat State Biotechnology Mission. Founded by young entrepreneurs and experienced research and manufacturing professionals, the company focuses on innovating and manufacturing semi-synthetic, synthetic, and fermentation-based APIs. Its R&D facility is equipped with advanced technology for synthesis, extraction, isolation, purification, and upstream fermentation, with active work in process chemistry for therapeutic molecules. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Sumar Biotech

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    04

    Gonane Pharma

    India
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    iPHEX India
    Attending
    • fda
    • EDQM
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    Virtual BoothGonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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    Everolimus

    About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...

    Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology products. The company is supported by a dedicated team and promoters with over 25 years of experience in manufacturing, product promotion, and regulatory audits across markets including the EU, Mexico, China, Korea, and Russia. Gonane Pharma is also engaged with Japanese customers and continues to expand into new markets. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Gonane Pharma

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    05

    Shanghai Minbiotech

    China
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    IPhEB Russia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

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    Everolimus

    About the Company : Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in...

    Shanghai Minbiotech is specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Shanghai Minbiotech CB

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    06

    Tenatra Exports

    India
    arrow
    IPhEB Russia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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    Everolimus

    About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...

    Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opportunities grew, it was felt that the proprietorship firm had outlived its usefulness and that it needed a corporate structure. So, Tenatra Exports Private Limited was incorporated in 2002. Since then, the company has come a long way, gaining valuable experience and knowledge in the fields of chemicals and pharmaceuticals in India. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Tenatra

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    07

    Fishfa Biogenics

    India
    arrow
    IPhEB Russia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothFishfa Biogenics: Renowned Manufacturer, & Exporter of Tacrolimus & Mupirocin API.

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    Everolimus

    About the Company : Fishfa Biogenics, a division of Fishfa Rubbers Ltd., manufactures and supplies biological APIs. The company operates GLP labs and WHO-GMP-certified facilities, specializing in ferm...

    Fishfa Biogenics, a division of Fishfa Rubbers Ltd., manufactures and supplies biological APIs. The company operates GLP labs and WHO-GMP-certified facilities, specializing in fermentation-based production, process development, and manufacturing. Its site includes microbial drug substance production, quality testing, and technical, regulatory, and IP support. Fishfa exports APIs such as Mupirocin and Tacrolimus to markets in Europe, Asia, the Middle East, South America, Russia, New Zealand, and the UK. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Fishfa Biogenics

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    08

    Omgene Life Sciences Pvt. Ltd

    India
    arrow
    IPhEB Russia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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    Everolimus

    About the Company : Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...

    Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
    Omgene Company Banner

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    09

    Brawn Laboratories Ltd

    India
    IPhEB Russia
    Not Confirmed
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    Brawn Laboratories Ltd

    India
    arrow
    IPhEB Russia
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Everolimus

    About the Company : BRAWN is a WHO GMP & ISO 9001:2008 Certified company with state of the art plant located in Faridabad, some 30 kms from New Delhi. Spread over more than 125000 sq ft floor area, i...

    BRAWN is a WHO GMP & ISO 9001:2008 Certified company with state of the art plant located in Faridabad, some 30 kms from New Delhi. Spread over more than 125000 sq ft floor area, it has three separate blocks to manufacture Non Beta, Cephalosporin & Penicillin products, manufacturing a large variety of finished formulations covering all dosage forms.
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    10

    Murli Krishna Pharma

    India
    IPhEB Russia
    Not Confirmed
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    Murli Krishna Pharma

    India
    arrow
    IPhEB Russia
    Not Confirmed
    • fda
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    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
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    Everolimus

    About the Company : Murli Krishna Pharma Private Ltd. is a young and dynamic drug delivery systems (DDS) company in India that provides a range of effective solutions to optimize the delivery of pharm...

    Murli Krishna Pharma Private Ltd. is a young and dynamic drug delivery systems (DDS) company in India that provides a range of effective solutions to optimize the delivery of pharmaceutical products.Our manufacturing plant is approved for GMP Compliance by the WHO and the European Union; Murli Krishna Pharma is equipped to undertake formulation development projects on oral NDDS.
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    API Reference Price

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LTD","customerCountry":"INDIA","quantity":"0.07","actualQuantity":"65","unit":"GMS","unitRateFc":"300","totalValueFC":"22541.4","currency":"USD","unitRateINR":"28822.4","date":"18-Jan-2024","totalValueINR":"1873453.95","totalValueInUsd":"22541.4","indian_port":"Madras Air","hs_no":"29349990","bill_no":"9713989","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"& BIOTECH CO. LTD.,1 TUNG-HSING STREET,NEW TAIPEI CITY 23850 TAIWAN","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705516200,"product":"EVEROLIMUS (WITH BHT) MAKE ZWW LOT NO.12268207","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"CHUNGHWA CHEMICAL SYNTHESIS","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"30","unit":"GMS","unitRateFc":"300","totalValueFC":"10403.7","currency":"USD","unitRateINR":"28822.4","date":"18-Jan-2024","totalValueINR":"864671.05","totalValueInUsd":"10403.7","indian_port":"Madras Air","hs_no":"29349990","bill_no":"9713989","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"& BIOTECH CO. LTD.,1 TUNG-HSING STREET,NEW TAIPEI CITY 23850 TAIWAN","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705516200,"product":"EVEROLIMUS (WITHOUT BHT) MAKE ZWW LOT NO. 12138206","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"CHUNGHWA CHEMICAL SYNTHESIS","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"0.03","actualQuantity":"30","unit":"GMS","unitRateFc":"300","totalValueFC":"9943.9","currency":"USD","unitRateINR":"27548.6","date":"18-Jan-2024","totalValueINR":"826458.4","totalValueInUsd":"9943.9","indian_port":"Madras Air","hs_no":"29349990","bill_no":"9713993","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"& BIOTECH CO. LTD.,1 TUNG-HSING STREET,NEW TAIPEI CITY 23850 TAIWAN","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710959400,"product":"EVEROLIMUS (WITH BHT) MAKE CCSB LOT NO.12138204","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"CHUNGHWA CHEMICAL SYNTHESIS","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"1.32","actualQuantity":"1315","unit":"GMS","unitRateFc":"375","totalValueFC":"501400.9","currency":"USD","unitRateINR":"31661","date":"21-Mar-2024","totalValueINR":"41634218.75","totalValueInUsd":"501400.9","indian_port":"Madras Air","hs_no":"29349990","bill_no":"2678540","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"& BIOTECH CO. LTD.,1 TUNG-HSING STREET,NEW TAIPEI CITY 23850 TAIWAN","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719253800,"product":"EVEROLIMUS IP 20.00 MG \/ LOT NO.EVE0018036 (R & D PURPOSE ONLY)","address":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM","city":"","supplier":"CHUNGHWA CHEMICAL SYNTHESIS","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"PAR FORMULATIONS PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"20","unit":"MGS","unitRateFc":"212.5","totalValueFC":"5099.6","currency":"USD","unitRateINR":"21285.8","date":"25-Jun-2024","totalValueINR":"425715","totalValueInUsd":"5099.6","indian_port":"Madras Air","hs_no":"29349990","bill_no":"4168396","productDescription":"R&D Sample","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"& BIOTECH CO. LTD.,1 TUNG-HSING STREET,NEW TAIPEI CITY 23850 TAIWAN","customerAddress":"OLD NO.1\/63, NEW NO.1\/58 PUDUPAKKAM"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1739557800,"product":"EVEROLIMUS (159351-69-6) (LAB CHEMICAL FOR RESEARCH USE) EVEROLIMUS (159351-69-6) (LAB CHEMICAL FOR RESEARCH USE)","address":"14\/5, Mathura Road, Faridabad,","city":"FARIDABAD","supplier":"LUYUNJIA CHEMISTRY XIAMEN","supplierCountry":"CHINA","foreign_port":"HONG KONG","customer":"NEWTECH MEDICAL DEVICES PRIVATE LTD","customerCountry":"INDIA","quantity":"0.02","actualQuantity":"20","unit":"GMS","unitRateFc":"1003.1","totalValueFC":"20392.8","currency":"USD","unitRateINR":"88671.9","date":"15-Feb-2025","totalValueINR":"1773437.71","totalValueInUsd":"20392.8","indian_port":"Delhi Air","hs_no":"29349990","bill_no":"8372076","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"LIMITED ROOM1201 , NO.488-3 JIAHE ROAD, HULI DISTRICT, XIAMEN, SDNF CHINA","customerAddress":"14\/5, Mathura Road, Faridabad,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1751394600,"product":"EVEROLIMUS (SPEC-1) EVEROLIMUS (SPEC-1)","address":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,","city":"HYDERABAD,TELANGANA","supplier":"CHUNGHWA CHEMICAL SYNTHESIS BIOTECH CO LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"DR REDDY'S LABORATORIES","customerCountry":"INDIA","quantity":"2.58","actualQuantity":"2.583","unit":"KGS","unitRateFc":"220000","totalValueFC":"578719","currency":"USD","unitRateINR":"19283000","date":"02-Jul-2025","totalValueINR":"49807989","totalValueInUsd":"578719","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"3001457","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"1 TUNG-HSING STREET, SHU-LIN DIST., NEW TAIPEI CITY 23850, TAIWAN, R.O .C. TAIWAN Taiwan","customerAddress":"H.NO. 8-2-337, BESIDE TV9 OFFICE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2026","qtr":"Q1","strtotime":1770661800,"product":"SNCM-PC-STD. EVEROLIMUS BHT (RAD001) RATE 8700570 LOT: 30336 0 (FOC) (REFERANCE STANDARD)","address":"SANDOZ HOUSE,8TH FLOOR,","city":"MUMBAI,MAHARASHTRA","supplier":"UNDISCLOSED","supplierCountry":"SLOVENIA","foreign_port":"LJUBLJANA","customer":"NOVARTIS HEALTHCARE PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.12","unit":"GMS","unitRateFc":"4272","totalValueFC":"515.9","currency":"EURO","unitRateINR":"390247.4","date":"10-Feb-2026","totalValueINR":"46829.69","totalValueInUsd":"515.9","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"0","productDescription":"R&D Sample","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LJUBLJANA","supplierAddress":"N\/A","customerAddress":"SANDOZ HOUSE,8TH FLOOR,"}]
    10-Jan-2022
    10-Feb-2026
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    Canada

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    01

    DR REDDY'S LABORATORIES LTD

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    EVEROLIMUS

    Brand Name : REDDY-EVEROLIMUS

    Dosage Form : TABLET

    Dosage Strength : 2.5MG

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    Approval Date :

    Application Number : 2532409

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    02

    DR REDDY'S LABORATORIES LTD

    India
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    EVEROLIMUS

    Brand Name : REDDY-EVEROLIMUS

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    Dosage Strength : 5MG

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    Application Number : 2532417

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    Website

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    03

    DR REDDY'S LABORATORIES LTD

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    EVEROLIMUS

    Brand Name : REDDY-EVEROLIMUS

    Dosage Form : TABLET

    Dosage Strength : 10MG

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    Approval Date :

    Application Number : 2532433

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    04

    NATCO PHARMA (CANADA) INC

    Canada
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    NATCO PHARMA (CANADA) INC

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    EVEROLIMUS

    Brand Name : NAT-EVEROLIMUS

    Dosage Form : TABLET

    Dosage Strength : 5MG

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    Application Number : 2530104

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    Registration Country : Canada

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    05

    NOVARTIS PHARMACEUTICALS CANADA INC

    Switzerland
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    Not Confirmed
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    NOVARTIS PHARMACEUTICALS CANADA INC

    Switzerland
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    EVEROLIMUS

    Brand Name : AFINITOR

    Dosage Form : TABLET

    Dosage Strength : 5MG

    Packaging : 30

    Approval Date :

    Application Number : 2339501

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    Registration Country : Canada

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    06

    NOVARTIS PHARMACEUTICALS CANADA INC

    Switzerland
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    Not Confirmed
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    NOVARTIS PHARMACEUTICALS CANADA INC

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    EVEROLIMUS

    Brand Name : AFINITOR DISPERZ

    Dosage Form : TABLET FOR SUSPENSION

    Dosage Strength : 2MG

    Packaging : 90

    Approval Date :

    Application Number : 2425645

    Regulatory Info : PRESCRIPTION

    Registration Country : Canada

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    07

    NOVARTIS PHARMACEUTICALS CANADA INC

    Switzerland
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    NOVARTIS PHARMACEUTICALS CANADA INC

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    EVEROLIMUS

    Brand Name : AFINITOR DISPERZ

    Dosage Form : TABLET FOR SUSPENSION

    Dosage Strength : 3MG

    Packaging : 90

    Approval Date :

    Application Number : 2425653

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    08

    PHARMASCIENCE INC

    Canada
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    PHARMASCIENCE INC

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    EVEROLIMUS

    Brand Name : PMS-EVEROLIMUS

    Dosage Form : TABLET

    Dosage Strength : 5MG

    Packaging :

    Approval Date :

    Application Number : 2504685

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    Registration Country : Canada

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    09

    SANDOZ CANADA INCORPORATED

    Switzerland
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    SANDOZ CANADA INCORPORATED

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    EVEROLIMUS

    Brand Name : SANDOZ EVEROLIMUS

    Dosage Form : TABLET

    Dosage Strength : 2.5MG

    Packaging :

    Approval Date :

    Application Number : 2492911

    Regulatory Info : PRESCRIPTION

    Registration Country : Canada

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    10

    SANDOZ CANADA INCORPORATED

    Switzerland
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    SANDOZ CANADA INCORPORATED

    Switzerland
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    EVEROLIMUS

    Brand Name : SANDOZ EVEROLIMUS

    Dosage Form : TABLET

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

    Application Number : 2492946

    Regulatory Info : PRESCRIPTION

    Registration Country : Canada

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET, FOR SUSPENSION;ORAL - 2MG

    USFDA APPLICATION NUMBER - 203985

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    DOSAGE - TABLET, FOR SUSPENSION;ORAL - 3MG

    USFDA APPLICATION NUMBER - 203985

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    DOSAGE - TABLET, FOR SUSPENSION;ORAL - 5MG

    USFDA APPLICATION NUMBER - 203985

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    DOSAGE - TABLET;ORAL - 10MG

    USFDA APPLICATION NUMBER - 22334

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    DOSAGE - TABLET;ORAL - 2.5MG

    USFDA APPLICATION NUMBER - 22334

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    DOSAGE - TABLET;ORAL - 5MG

    USFDA APPLICATION NUMBER - 22334

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    DOSAGE - TABLET;ORAL - 7.5MG

    USFDA APPLICATION NUMBER - 22334

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    ABOUT THIS PAGE

    Looking for 159351-69-6 / Everolimus API manufacturers, exporters & distributors?

    Everolimus manufacturers, exporters & distributors 1

    65

    PharmaCompass offers a list of Everolimus 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 Everolimus manufacturer or Everolimus supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Everolimus manufacturer or Everolimus supplier.

    PharmaCompass also assists you with knowing the Everolimus API Price utilized in the formulation of products. Everolimus API Price is not always fixed or binding as the Everolimus Price is obtained through a variety of data sources. The Everolimus Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Everolimus

    Synonyms

    001, rad, 40-o-(2-hydroxyethyl)-rapamycin, 40-o-(2-hydroxyethyl)rapamycin, Afinitor, Certican, Rad

    Cas Number

    159351-69-6

    Unique Ingredient Identifier (UNII)

    9HW64Q8G6G

    About Everolimus

    A derivative of sirolimus and an inhibitor of TOR SERINE-THREONINE KINASES. It is used to prevent GRAFT REJECTION in heart and kidney transplant patients by blocking cell proliferation signals. It is also an ANTINEOPLASTIC AGENT.

    RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus Manufacturers

    A RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus, including repackagers and relabelers. The FDA regulates RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus 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 RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus Suppliers

    A RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus supplier is an individual or a company that provides RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus active pharmaceutical ingredient (API) or RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus finished formulations upon request. The RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus suppliers may include RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus API manufacturers, exporters, distributors and traders.

    click here to find a list of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus USDMF

    A RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus DMF (Drug Master File) is a document detailing the whole manufacturing process of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus active pharmaceutical ingredient (API) in detail. Different forms of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus DMFs exist exist since differing nations have different regulations, such as RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus DMF submitted to regulatory agencies in the US is known as a USDMF. RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus USDMF includes data on RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus suppliers with USDMF on PharmaCompass.

    RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus JDMF

    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 RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus Drug Master File in Japan (RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus JDMF) empowers RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus 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 RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus JDMF during the approval evaluation for pharmaceutical products. At the time of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus 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 RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus suppliers with JDMF on PharmaCompass.

    RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus Drug Master File in Korea (RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus. The MFDS reviews the RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus KDMF as part of the drug registration process and uses the information provided in the RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus KDMF to evaluate the safety and efficacy of the drug.

    After submitting a RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus suppliers with KDMF on PharmaCompass.

    RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus CEP

    A RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus CEP of the European Pharmacopoeia monograph is often referred to as a RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus Certificate of Suitability (COS). The purpose of a RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus to their clients by showing that a RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus CEP has been issued for it. The manufacturer submits a RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus CEP (COS) as part of the market authorization procedure, and it takes on the role of a RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus CEP holder for the record. Additionally, the data presented in the RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus DMF.

    A RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus suppliers with CEP (COS) on PharmaCompass.

    RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus WC

    A RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus written confirmation (RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus WC) is an official document issued by a regulatory agency to a RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus manufacturer, verifying that the manufacturing facility of a RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus APIs or RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus finished pharmaceutical products to another nation, regulatory agencies frequently require a RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus WC (written confirmation) as part of the regulatory process.

    click here to find a list of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus suppliers with Written Confirmation (WC) on PharmaCompass.

    RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus NDC

    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 RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    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 RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus 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.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus suppliers with NDC on PharmaCompass.

    RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus GMP

    RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus 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 RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus 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 RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus GMP manufacturer or RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus GMP API supplier for your needs.

    RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus CoA

    A RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus CoA (Certificate of Analysis) is a formal document that attests to RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus's compliance with RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus specifications and serves as a tool for batch-level quality control.

    RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus CoA mostly includes findings from lab analyses of a specific batch. For each RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus 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.

    RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus may be tested according to a variety of international standards, such as European Pharmacopoeia (RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus EP), RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus JP (Japanese Pharmacopeia) and the US Pharmacopoeia (RAD001, SDZ-RAD, Certican, Zortress, Afinitor, Everolimus USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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