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    Chemistry

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    Also known as: Zoledronate, 118072-93-8, Zometa, Reclast, Aclasta, (1-hydroxy-2-(1h-imidazol-1-yl)ethane-1,1-diyl)diphosphonic acid
    Molecular Formula
    C5H10N2O7P2
    Molecular Weight
    272.09  g/mol
    InChI Key
    XRASPMIURGNCCH-UHFFFAOYSA-N
    FDA UNII
    70HZ18PH24
    Zoledronic Acid
    An imidobisphosphonate inhibitor of BONE RESORPTION that is used for the treatment of malignancy-related HYPERCALCEMIA; OSTEITIS DEFORMANS; and OSTEOPOROSIS.
    Zoledronic acid anhydrous is a Bisphosphonate.
    1 2D Structure

    Zoledronic Acid

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1-hydroxy-2-imidazol-1-yl-1-phosphonoethyl)phosphonic acid
    2.1.2 InChI
    InChI=1S/C5H10N2O7P2/c8-5(15(9,10)11,16(12,13)14)3-7-2-1-6-4-7/h1-2,4,8H,3H2,(H2,9,10,11)(H2,12,13,14)
    2.1.3 InChI Key
    XRASPMIURGNCCH-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1=CN(C=N1)CC(O)(P(=O)(O)O)P(=O)(O)O
    2.2 Other Identifiers
    2.2.1 UNII
    70HZ18PH24
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-(imidazol-1-yl)-1-hydroxyethylidene-1,1-bisphosphonic Acid

    2. Cgp 42'446

    3. Cgp 42446

    4. Cgp 42446a

    5. Cgp-42'446

    6. Cgp-42446

    7. Cgp42'446

    8. Cgp42446

    9. Zoledronate

    10. Zoledronic Acid Anhydrous

    11. Zometa

    2.3.2 Depositor-Supplied Synonyms

    1. Zoledronate

    2. 118072-93-8

    3. Zometa

    4. Reclast

    5. Aclasta

    6. (1-hydroxy-2-(1h-imidazol-1-yl)ethane-1,1-diyl)diphosphonic Acid

    7. Cgp 42446

    8. (1-hydroxy-2-imidazol-1-ylethylidene)diphosphonic Acid

    9. Zoledronic Acid Anhydrous

    10. Anhydrous Zoledronic Acid

    11. (1-hydroxy-2-imidazol-1-yl-1-phosphonoethyl)phosphonic Acid

    12. Phosphonic Acid, [1-hydroxy-2-(1h-imidazol-1-yl)ethylidene]bis-

    13. Zol

    14. [1-hydroxy-2-(1h-imidazol-1-yl)ethane-1,1-diyl]bis(phosphonic Acid)

    15. Orazol

    16. Zol 446

    17. Zoledronic Acid (inn)

    18. Cgp-42446

    19. Reclast (tn)

    20. Zometa (tn)

    21. Chembl924

    22. Zoledronic Acid Teva

    23. Zoledronic Acid, Anhydrous

    24. Nsc-721517

    25. Zoledronic Acid Medac

    26. Chebi:46557

    27. [1-hydroxy-2-(1h-imidazol-1-yl)-1-phosphonoethyl]phosphonic Acid

    28. 70hz18ph24

    29. Ncgc00159521-02

    30. (1-hydroxy-2-(1h-imidazol-1-yl)ethylidene)bisphosphonic Acid

    31. Cgp-42446a

    32. Zoledronate Hydrate

    33. Zoledronic Acid [usan:inn:ban]

    34. Phosphonic Acid, (1-hydroxy-2-(1h-imidazol-1-yl)ethylidene)bis-

    35. Zoladrona Acid Mylan

    36. Zoledronic

    37. Zoledronic Acid Accord

    38. Zoledronic Acid [inn]

    39. Zomera

    40. 1-hydroxy-2-(1h-imidazol-1-yl)ethane-1,1-diyldiphosphonic Acid

    41. Bisphosphonate 3

    42. Zometa (novartis)

    43. Aclasta And Reclast

    44. C5h10n2o7p2

    45. [1-hydroxy-2-(1h-imidazol-1-yl)ethylidene]bisphosphonic Acid

    46. Zoledronic-acid

    47. Unii-70hz18ph24

    48. Bph 91

    49. [1-hydroxy-2-(1h-imidazol-1-yl)-ethylidene]bisphosphonic Acid

    50. Dsstox_cid_22668

    51. Dsstox_rid_80065

    52. Zoledronic Acid, Zoledronate

    53. Bidd:pxr0134

    54. Dsstox_gsid_42668

    55. Schembl19054

    56. Zoledronic Acid [mi]

    57. Bidd:gt0292

    58. Zoledronic Acid (zoledronate)

    59. Gtpl3177

    60. Jmc515594 Compound 55

    61. Dtxsid0042668

    62. Bdbm12578

    63. Cgp42446a

    64. Zoledronic Acid [who-dd]

    65. Hms2089o09

    66. Bcp22750

    67. Cgp-4244

    68. Zinc3803652

    69. Tox21_111739

    70. Mfcd00867791

    71. Nsc721517

    72. S1314

    73. Stl452893

    74. Akos005145739

    75. Ab07564

    76. Ac-1092

    77. Cs-1829

    78. Db00399

    79. Hs-0091

    80. Nsc 721517

    81. Ncgc00159521-03

    82. Ncgc00159521-04

    83. Ncgc00159521-05

    84. Ncgc00159521-09

    85. Ncgc00159521-18

    86. Hy-13777

    87. Cas-118072-93-8

    88. Ft-0601384

    89. Z0031

    90. D08689

    91. H11422

    92. S00092

    93. Ab01273947-01

    94. Ab01273947-02

    95. Ab01273947-03

    96. Ab01273947_04

    97. 072z938

    98. A803876

    99. Q218507

    100. Sr-05000001436

    101. Q-201946

    102. Sr-05000001436-1

    103. 1-hydroxy-2-(1-imidazolyl)ethane-1,1-diphosphonic Acid

    104. Z1691545083

    105. (1-hydroxy-2-(1h-imidazol-1-yl)ethane-1,1-diyl)diphosphonicacid

    2.4 Create Date
    2005-03-26
    3 Chemical and Physical Properties
    Molecular Weight 272.09 g/mol
    Molecular Formula C5H10N2O7P2
    XLogP3-4.3
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count4
    Exact Mass271.99632466 g/mol
    Monoisotopic Mass271.99632466 g/mol
    Topological Polar Surface Area153 Ų
    Heavy Atom Count16
    Formal Charge0
    Complexity327
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 6  
    Drug NameReclast
    Drug LabelReclast contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formul...
    Active IngredientZoledronic acid
    Dosage FormInjectable
    Routeinjection; Iv (infusion)
    Strengtheq 5mg base/100ml; 5mg/100ml
    Market StatusPrescription
    CompanyNovartis Pharms; Novartis

    2 of 6  
    Drug NameZoledronic acid
    PubMed HealthZoledronic Acid (Injection)
    Drug ClassesCalcium Regulator
    Drug LabelZoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its...
    Active IngredientZoledronic acid
    Dosage FormInjectable
    Routeinjection; Iv (infusion); Injection; iv (infusion)
    Strengtheq 5mg base/100ml; 5mg/100ml; 4mmg; eq 4mg base/100ml; eq 4mg base/5ml; 4mg/100ml; 4mg/5ml(0.8mg/ml); eq 4mg base/vial
    Market StatusTentative Approval; Prescription
    CompanyPharmaceutics; Hospira; Gland Pharma; Teva Parenteral; Apotex; Hikma Farmaceutica; Usv North America; Acs Dobfar Info Sa; Pharmaforce; Cipla; Sun Pharma Global; Emcure Pharms; Pharms; Dr Reddys Labs; Agila Speclts; Actavis; Akorn

    3 of 6  
    Drug NameZometa
    PubMed HealthZoledronic Acid (Injection)
    Drug ClassesCalcium Regulator
    Drug LabelZometa contains zoledronicacid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronicacid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formu...
    Active IngredientZoledronic acid
    Dosage FormInjectable
    RouteIv (infusion); iv (infusion)
    Strengtheq 4mg base/100ml; eq 4mg base/5ml; eq 4mg base/vial
    Market StatusPrescription
    CompanyNovartis

    4 of 6  
    Drug NameReclast
    Drug LabelReclast contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formul...
    Active IngredientZoledronic acid
    Dosage FormInjectable
    Routeinjection; Iv (infusion)
    Strengtheq 5mg base/100ml; 5mg/100ml
    Market StatusPrescription
    CompanyNovartis Pharms; Novartis

    5 of 6  
    Drug NameZoledronic acid
    PubMed HealthZoledronic Acid (Injection)
    Drug ClassesCalcium Regulator
    Drug LabelZoledronic Acid Injection contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its...
    Active IngredientZoledronic acid
    Dosage FormInjectable
    Routeinjection; Iv (infusion); Injection; iv (infusion)
    Strengtheq 5mg base/100ml; 5mg/100ml; 4mmg; eq 4mg base/100ml; eq 4mg base/5ml; 4mg/100ml; 4mg/5ml(0.8mg/ml); eq 4mg base/vial
    Market StatusTentative Approval; Prescription
    CompanyPharmaceutics; Hospira; Gland Pharma; Teva Parenteral; Apotex; Hikma Farmaceutica; Usv North America; Acs Dobfar Info Sa; Pharmaforce; Cipla; Sun Pharma Global; Emcure Pharms; Pharms; Dr Reddys Labs; Agila Speclts; Actavis; Akorn

    6 of 6  
    Drug NameZometa
    PubMed HealthZoledronic Acid (Injection)
    Drug ClassesCalcium Regulator
    Drug LabelZometa contains zoledronicacid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronicacid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formu...
    Active IngredientZoledronic acid
    Dosage FormInjectable
    RouteIv (infusion); iv (infusion)
    Strengtheq 4mg base/100ml; eq 4mg base/5ml; eq 4mg base/vial
    Market StatusPrescription
    CompanyNovartis

    4.2 Drug Indication

    Zoledronic acid is indicated to treat hypercalcemia of malignancy, multiple myeloma, bone metastases from solid tumors, osteoporosis in men and postmenopausal women, glucocorticoid induced osteoporosis, and Paget's disease of bone in men and women. Zoledronic acid is also indicated for the prevention of osteoporosis in post menopausal women and glucocorticoid induced osteoporosis.

    Prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia.

    Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.

    Treatment of adult patients with tumour-induced hypercalcaemia.

    * 4 mg / 5 ml and 4 mg / 100 ml: :

    - Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.

    - Treatment of adult patients with tumour-induced hypercalcaemia (TIH).

    * 5 mg / 100 ml: :

    Treatment of osteoporosis:

    - in post-menopausal women;

    - in men;

    at increased risk of fracture, including those with a recent low-trauma hip fracture.

    Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy:

    - in post-menopausal women;

    - in men;

    at increased risk of fracture.

    Treatment of Paget's disease of the bone in adults.

    Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.

    Treatment of adult patients with tumour-induced hypercalcaemia (TIH).

    - Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone;

    - treatment of adult patients with tumour-induced hypercalcaemia (TIH).

    Treatment of osteoporosis:

    - in post-menopausal women;

    - in men;

    at increased risk of fracture, including those with a recent low-trauma hip fracture.

    Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in post-menopausal women and in men at increased risk of fracture.

    Treatment of Paget's disease of the bone.

    Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.

    Treatment of adult patients with tumour-induced hypercalcaemia (TIH).

    Treatment of osteoporosis:

    - in post-menopausal women;

    - in men;

    at increased risk of fracture including those with a recent low-trauma hip fracture.

    Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy:

    - in post-menopausal women;

    - in men;

    at increased risk of fracture.

    Treatment of Pagets disease of the bone in adults.

    - Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone;

    - treatment of tumour-induced hypercalcaemia (TIH);

    - prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone;

    - treatment of tumour-induced hypercalcaemia (TIH);

    - prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone;

    - treatment of adult patients with tumour-induced hypercalcaemia (TIH).

    Treatment of osteoporosis

    - in post-menopausal women

    - in adult men

    at increased risk of fracture, including those with recent low-trauma hip fracture.

    Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy

    - in post-menopausal women

    - in adult men

    at increased risk of fracture.

    Treatment of Paget's disease of the bone in adults.

    Osteogenesis imperfecta, Prevention of fracture and bone loss in postmenopausal women with early-stage breast cancer treated with aromatase inhibitors, Prevention of skeletal related events in patients with advanced malignancies involving bone, Tumour-induced hypercalcaemia

    Treatment of osteoporosis, Treatment of Pagets disease of the bone

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Zoledronic acid is a third generation, nitrogen containing bisphosphonate that inhibits osteoclast function and prevents bone resorption. The therapeutic window is wide as patients are unlikely to suffer severe effects from overdoses and the duration of action is long. Patients should be counselled regarding the risk of electrolyte deficiencies, renal impairment, osteonecrosis of the jaw, atypical femoral fractures, bronchoconstriction, hepatic impairment, hypocalcemia, and embryo-fetal toxicity.

    5.2 MeSH Pharmacological Classification

    Bone Density Conservation Agents

    Agents that inhibit BONE RESORPTION and/or favor BONE MINERALIZATION and BONE REGENERATION. They are used to heal BONE FRACTURES and to treat METABOLIC BONE DISEASES such as OSTEOPOROSIS. (See all compounds classified as Bone Density Conservation Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    ZOLEDRONIC ACID ANHYDROUS
    5.3.2 FDA UNII
    70HZ18PH24
    5.3.3 Pharmacological Classes
    Diphosphonates [CS]; Bisphosphonate [EPC]
    5.4 ATC Code

    M05BA08

    M05BA08

    M05BA08

    M05BA08

    M05BA08

    M05BA08

    M05BA08

    M05BA08

    M05BA08

    M05BA08

    M05BA08

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    M - Musculo-skeletal system

    M05 - Drugs for treatment of bone diseases

    M05B - Drugs affecting bone structure and mineralization

    M05BA - Bisphosphonates

    M05BA08 - Zoledronic acid

    5.5 Absorption, Distribution and Excretion

    Absorption

    A 4mg intravenous dose reaches a Cmax of 37078.5ng/mL, with a Tmax of 0.3170.014h, and an AUC of 788181ng\*h/mL. A 5mg intravenous dose reaches a Cmax of 47176.1ng/mL, with a Tmax of 0.3680.005h, and an AUC of 917226ng\*h/mL.

    Route of Elimination

    Zoledronic acid is 39 16% eliminated in the urine as the unmetabolized parent drug.

    Clearance

    Zoledronic acid has a renal clearance of 3.7 2.0 L/h.

    5.6 Metabolism/Metabolites

    Zoledronic acid is not metabolized _in vivio_.

    5.7 Biological Half-Life

    Zoledronic acid has a terminal elimination half life of 146 hours.

    5.8 Mechanism of Action

    Bisphosphonates are taken into the bone where they bind to hydroxyapatite. Bone resorption by osteoclasts causes local acidification, releasing the bisphosphonate, which is taken into the osteoclast by fluid-phase endocytosis. Endocytic vesicles become acidified, releasing bisphosphonates into the cytosol of osteoclasts where they act. Osteoclasts mediate resorption of bone. When osteoclasts bind to bone they form podosomes, ring structures of F-actin. Etidronic acid also inhibits V-ATPases in the osteoclast, though the exact subunits are unknown, preventing F-actin from forming podosomes. Disruption of the podosomes causes osteoclasts to detach from bones, preventing bone resorption. Nitrogen containing bisphosphonates such as zoledronate are known to induce apoptosis of hematopoietic tumor cells by inhibiting the components of the mevalonate pathway farnesyl diphosphate synthase, farnesyl diphosphate, and geranylgeranyl diphosphate. These components are essential for post-translational prenylation of GTP-binding proteins like Rap1. The lack of prenylation of these proteins interferes with their function, and in the case of Rap1, leads to apoptosis. zoledronate also activated caspases which further contribute to apoptosis.

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PHARMERA","customerCountry":"RUSSIA","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"75000","totalValueFC":"14764.1","currency":"USD","unitRateINR":6135335,"date":"31-Jan-2024","totalValueINR":"1227067","totalValueInUsd":"14764.1","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"7167107","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"HETERO CORPORATE, NO. 7-2-A2,, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708885800,"product":"ZOLEDRONIC ACID (MONOHYDRATE) PH.EUR (ORGANIC COMPOUNDS) (OTHER REF CI NO:523152) APPENDIX 4R,RODTEP ENTRY NO:9782","address":"NATCO HOUSE, ROAD NO.2,","city":"HYDERABAD, A.P.","supplier":"NATCO PHARMA","supplierCountry":"INDIA","foreign_port":"TUNIS","customer":"LES LABORATOIRES DU SAINT-LAURENT E.H. LTEE","customerCountry":"TUNISIA","quantity":"0.10","actualQuantity":"100","unit":"GMS","unitRateFc":"175","totalValueFC":"17214.7","currency":"USD","unitRateINR":14283.67,"date":"26-Feb-2024","totalValueINR":"1428367","totalValueInUsd":"17214.7","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"7840094","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TUNISIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"NATCO HOUSE, ROAD NO.2,, HYDERABAD, A.P.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719340200,"product":"ZOLEDRONIC ACID","address":"12 6 214 A1 SHILPA HOUSE HYDERABAD ROAD","city":"RAICHUR","supplier":"SHILPA PHARMA LIFESCIENCES LIMITED","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"GENVEON ILAC SAN.TIC.A.S.","customerCountry":"TURKEY","quantity":"0.07","actualQuantity":"70","unit":"GMS","unitRateFc":"75","totalValueFC":"5088","currency":"USD","unitRateINR":6067.7714285714283,"date":"26-Jun-2024","totalValueINR":"424744","totalValueInUsd":"5088","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"1953583","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"12 6 214 A1 SHILPA HOUSE HYDERABAD ROAD, RAICHUR","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1719426600,"product":"ZOLEDRONIC ACID, BATCH NO. 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FUHLSBUETT","customer":"ICARGO INTERNATIONALE LOGISTIK ","customerCountry":"GERMANY","quantity":"0.38","actualQuantity":"0.38","unit":"KGS","unitRateFc":"60000","totalValueFC":"22443.5","currency":"USD","unitRateINR":4937043.8421052629,"date":"20-Jul-2024","totalValueINR":"1876076.66","totalValueInUsd":"22443.5","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"2565487","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"HETERO CORPORATE, NO. 7-2-A2,, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721673000,"product":"ZOLEDRONIC ACID IH","address":"HETERO CORPORATE, NO. 7-2-A2,","city":"HYDERABAD","supplier":"HETERO DRUGS","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"TO THE ORDER OF","customerCountry":"RUSSIA","quantity":"0.40","actualQuantity":"0.4","unit":"KGS","unitRateFc":"55000","totalValueFC":"21677","currency":"USD","unitRateINR":4530011.2249999996,"date":"23-Jul-2024","totalValueINR":"1812004.49","totalValueInUsd":"21677","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"2636069","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"HETERO CORPORATE, NO. 7-2-A2,, HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726597800,"product":"PHARMACEUTICAL RAW MATERIAL - 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NOIBAI","customer":"PHARBACO CENTRAL PHARMACEUTICAL ","customerCountry":"VIETNAM","quantity":"0.02","actualQuantity":"20","unit":"GMS","unitRateFc":"64.1","totalValueFC":"1265.1","currency":"USD","unitRateINR":5374.75,"date":"18-Dec-2024","totalValueINR":"107495","totalValueInUsd":"1265.1","indian_port":"Bombay Air","hs_no":"29209000","bill_no":"6560539","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"VIETNAM","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"304, TOWN CENTRE, ANDHERI KURLA, MUMBAI \/ MAHARASHTRA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1640370600,"product":"CHEMICAL : ZOLEDRONIC ACID MONOHYDRATE","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"CHEMO","supplierCountry":"ARGENTINA","foreign_port":"BUENOS AIRES BA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"100","totalValueFC":"51142.7","currency":"USD","unitRateINR":"7715","date":"25-Dec-2021","totalValueINR":"3857500","totalValueInUsd":"51142.7","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"6832027","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BUENOS AIRES BA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1660847400,"product":"CHEMICAL : ZOLEDRONIC ACID MONOHYDRATE","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"CHEMO","supplierCountry":"ARGENTINA","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"100","totalValueFC":"50586.2","currency":"USD","unitRateINR":"8050","date":"19-Aug-2022","totalValueINR":"4025000","totalValueInUsd":"50586.2","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"2068339","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. 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SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD,GUJARAT","supplier":"CHEMO","supplierCountry":"ARGENTINA","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"100","totalValueFC":"51065.4","currency":"USD","unitRateINR":"8370","date":"06-Apr-2023","totalValueINR":"4185000","totalValueInUsd":"51065.4","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"5400385","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691692200,"product":"ZOLEDRONIC ACID MONOHYDRATE EP ZOLEDRONIC ACID MONOHYDRATE","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ","city":"AHMEDABAD","supplier":"CHEMO","supplierCountry":"ARGENTINA","foreign_port":"NA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"100","totalValueFC":"50360","currency":"USD","unitRateINR":"8259.8","date":"11-Aug-2023","totalValueINR":"4171640","totalValueInUsd":"50360","indian_port":"AHEMDABAD AIR","hs_no":"29420090","bill_no":"0","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,, S.G. HIGHWAY, THALTEJ"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708713000,"product":"ZOLEDRONIC ACID","address":"PLOT NO.2, MAITRIVIHAR,","city":"HYDERABAD\/ANDHRA PRADESH","supplier":"CHEMO","supplierCountry":"ARGENTINA","foreign_port":"BUENOS AIRES, BA","customer":"AUROBINDO PHARMA LIMITED","customerCountry":"INDIA","quantity":"0.08","actualQuantity":"0.08","unit":"KGS","unitRateFc":"150000","totalValueFC":"12134","currency":"USD","unitRateINR":"12585000","date":"24-Feb-2024","totalValueINR":"1006800","totalValueInUsd":"12134","indian_port":"Hyderabad Air","hs_no":"29332990","bill_no":"2278441","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BUENOS AIRES, BA","supplierAddress":"LUGANO BRANCH, VIA F. PELLI 17, P.O. BOX, 6901 LUGANO, Lugano, , Switzerland Switzerland","customerAddress":"PLOT NO.2, MAITRIVIHAR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722277800,"product":"ZOLEDRONIC ACID MONOHYDRATE - 101435 (BATCH NO.00055 \/ (LICNO: SW\/ND\/CT-17\/2024\/000003082) \/ (QTY:500GRAMS)","address":"PLOT NO 113 114, IIND FLOOR,","city":"KUKATPALLY, HYDERABAD. AP.","supplier":"CHEMO","supplierCountry":"ARGENTINA","foreign_port":"BUENOS AIRES, BA","customer":"RICONPHARMA INDIA PRIVATE LIMITED","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"75","totalValueFC":"37930.2","currency":"USD","unitRateINR":"6341.3","date":"30-Jul-2024","totalValueINR":"3170625","totalValueInUsd":"37930.2","indian_port":"Hyderabad Air","hs_no":"29339990","bill_no":"4781131","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BUENOS AIRES, BA","supplierAddress":"MURGUIONDO 2011 CAPITALFEDERAL-C1440CNSSDNF AR","customerAddress":"PLOT NO 113 114, IIND FLOOR,"}]
    02-Jan-2021
    18-Dec-2024
    KGS
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    Average Price (USD/KGS)

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    Quantity (KGS) & Unit rate (USD/KGS) over time

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - INJECTABLE;INTRAVENOUS - EQ 4MG BASE...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 4MG BASE/100ML

    USFDA APPLICATION NUMBER - 203231

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    DOSAGE - INJECTABLE;INTRAVENOUS - EQ 4MG BASE...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21223

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    ABOUT THIS PAGE

    Zoledronic Acid Manufacturers

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

    Zoledronic Acid Suppliers

    A Zoledronic Acid supplier is an individual or a company that provides Zoledronic Acid active pharmaceutical ingredient (API) or Zoledronic Acid finished formulations upon request. The Zoledronic Acid suppliers may include Zoledronic Acid API manufacturers, exporters, distributors and traders.

    click here to find a list of Zoledronic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Zoledronic Acid USDMF

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

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

    click here to find a list of Zoledronic Acid suppliers with USDMF on PharmaCompass.

    Zoledronic Acid 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 Zoledronic Acid Drug Master File in Japan (Zoledronic Acid JDMF) empowers Zoledronic Acid 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 Zoledronic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Zoledronic Acid 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 Zoledronic Acid suppliers with JDMF on PharmaCompass.

    Zoledronic Acid KDMF

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

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

    After submitting a Zoledronic Acid 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 Zoledronic Acid API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Zoledronic Acid suppliers with KDMF on PharmaCompass.

    Zoledronic Acid CEP

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

    A Zoledronic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Zoledronic Acid 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 Zoledronic Acid suppliers with CEP (COS) on PharmaCompass.

    Zoledronic Acid WC

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

    click here to find a list of Zoledronic Acid suppliers with Written Confirmation (WC) on PharmaCompass.

    Zoledronic Acid 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 Zoledronic Acid as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Zoledronic Acid 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 Zoledronic Acid 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 Zoledronic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Zoledronic Acid NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Zoledronic Acid suppliers with NDC on PharmaCompass.

    Zoledronic Acid GMP

    Zoledronic Acid 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 Zoledronic Acid 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 Zoledronic Acid GMP manufacturer or Zoledronic Acid GMP API supplier for your needs.

    Zoledronic Acid CoA

    A Zoledronic Acid CoA (Certificate of Analysis) is a formal document that attests to Zoledronic Acid's compliance with Zoledronic Acid specifications and serves as a tool for batch-level quality control.

    Zoledronic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Zoledronic Acid 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.

    Zoledronic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Zoledronic Acid EP), Zoledronic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Zoledronic Acid 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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