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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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Polpharma

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Synnat Pharma

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LGM Pharma

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Dr. Reddy's Laboratories

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Laboratorium Ofichem B.V

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Polfa Tarchomin

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Tenatra Chemie

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Tofigh Daru

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Polpharma

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Zoledronic Acid

About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the c...

Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
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Virtual BoothSynnat Pharma is one of the leading active pharmaceutical ingredients and intermediates manufacturers.

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Zoledronic Acid

About the Company : Synnat Pharma is a fast-growing pharmaceutical company dedicated to the identification, development, production and distribution of potent phytochemicals and botanical extracts. AP...

Synnat Pharma is a fast-growing pharmaceutical company dedicated to the identification, development, production and distribution of potent phytochemicals and botanical extracts. APIs manufactured by Synnat are used by major drug formulators worldwide. Manufacturing activities are carried out as per ICH cGMP guidelines and several conventional and modern techniques are used for the isolation, semi-synthesis and purification of its products. Synnat Pharma has a presence in semi-regulated and non-regulated markets and is now entering regulated markets.
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LGM Pharma

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Zoledronic Acid

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

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

04

DKSH

Switzerland
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Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

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Zoledronic Acid

About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...

DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering growth for businesses in Asia and beyond for over 155 years. DKSH operates in 36 markets, is listed on the SIX Swiss Exchange, employs 33,100 specialists, and generated net sales of CHF 11.1 billion in 2021. It is the leading global distributor of innovative pharma ingredients for pharmaceutical synthesis and formulation. It offers a range of products, ranging from animal care products to packaging materials, intermediates to nutraceuticals, and APIs to excipients.
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05

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Antibody Engineering
Not Confirmed
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  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Zoledronic Acid

About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...

Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfolio that provides high-quality, low-cost APIs to leading pharma companies in 80+ countries. It has 8 USFDA-inspected facilities – 6 in India & 1 each in Mexico & the UK & are inspected by international regulatory authorities on a regular basis. Its facilities are supplemented by formulation facilities that provide a wide range of dosage forms. Product(s) under patent(s) are offered only for R&D purposes U/S 107A of the Patent Act and not for commercial sale
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06

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Antibody Engineering
Not Confirmed
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Virtual BoothLaboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.

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Zoledronic Acid

About the Company : Laboratorium Ofichem is a GMP-certified and FDA-approved API manufacturer with state-of-the-art development and production facilities in the Netherlands. We develop and manufacture...

Laboratorium Ofichem is a GMP-certified and FDA-approved API manufacturer with state-of-the-art development and production facilities in the Netherlands. We develop and manufacture small molecule APIs in a cost-effective, robust, and compliant way. We have our own portfolio of generic APIs, but we also operate as a CDMO for a wide range of customers. We are a stable family-owned business and with nearly 50 years of experience we have a long history of regulatory compliance and a strong reputation for reliability and quality.
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07

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Antibody Engineering
Not Confirmed
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Virtual BoothPolfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Zoledronic Acid

About the Company : Polfa Tarchomin located in Warsaw is pharmaceutical company with long tradition and experience in manufacturing and sales of pharmaceutical products. Our core business is related w...

Polfa Tarchomin located in Warsaw is pharmaceutical company with long tradition and experience in manufacturing and sales of pharmaceutical products. Our core business is related with: anti-infectives, CNS medicines, dermatology drugs and human insulin preparations. In general we are in position to produce: tablets and coated tablets; hard gelatinous capsules; dry bottled syrups; sterile powders for injections in glass vials and liquids in glass ampoules; insulin cartridges; dermatological: aerosols, solutions, gels. Polfa Tarchomin will be in position to produce high-potency injectables (vials and prefilled syringes) in 2025.
Polfa Tarchomin

08

Vamsi Labs

India
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  • EDQM
  • WHO-GMP

Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

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Zoledronic Acid

About the Company : Vamsi Labs, established in 1991, is a leading Indian API manufacturer. Specializing in anti-asthmatic, anti-migraine & anti-psychotic APIs, it caters to domestic & international ma...

Vamsi Labs, established in 1991, is a leading Indian API manufacturer. Specializing in anti-asthmatic, anti-migraine & anti-psychotic APIs, it caters to domestic & international markets(50% sales). Anti-asthma products account for 60% of sales. Vamsi adheres to high corporate governance, transparency, professionalism, & environmental protection standards. It's USFDA & EDQM certified & ISO 9001:2015, ISO 14001:2015, & ISO 45001:2018 certified. With a DSIR-certified R&D Lab, Vamsi continues to innovate & meet the pharma industry's evolving needs. Vamsi is poised to grow its globally while maintaining commitment to excellence and sustainability.
Vamsi Labs

09

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Antibody Engineering
Not Confirmed
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Virtual BoothTenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.

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Zoledronic Acid

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 Chemie Private Limited (TCPL) 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.
Tenatra

10

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Virtual BoothTofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.

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Zoledronic Acid

About the Company : Tofigh Daru (TODACO) belongs to the Tamin Pharmaceutical Investment Company, the biggest pharmaceutical holding in Iran. TODACO develops novel APIs in therapeutic categories like A...

Tofigh Daru (TODACO) belongs to the Tamin Pharmaceutical Investment Company, the biggest pharmaceutical holding in Iran. TODACO develops novel APIs in therapeutic categories like Anti-cancer, Anti-diabetics, Cardiovascular & Narcotics. Today, we boast to be the one & only producer of specialized APIs like Glatiramer, Fentanyl, Remifentanil, Atracurium, and peptides including long-acting Triptorelin and we have 5 PIC/s GMP-approved production lines. We also produce semi-finished products, granules for hazardous substances & FDF know-how, tech transfers & CTD compilations. We are exporting our products to Turkey, Bulgaria, Russia, & Algeria.
Tofigh Daru
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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":"50694","currency":"USD","unitRateINR":"8355","date":"19-Dec-2022","totalValueINR":"4177500","totalValueInUsd":"50694","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"3801160","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":"Q2","strtotime":1680805800,"product":"ZOLEDRONIC ACID","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":"50546.8","currency":"USD","unitRateINR":"8285","date":"07-Apr-2023","totalValueINR":"4142500","totalValueInUsd":"50546.8","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"5420638","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":1691001000,"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":"0.20","actualQuantity":"200","unit":"GMS","unitRateFc":"100","totalValueFC":"20144","currency":"USD","unitRateINR":"8259.8","date":"03-Aug-2023","totalValueINR":"1668656","totalValueInUsd":"20144","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"}]
02-Jan-2021
25-Oct-2024
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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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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DATA COMPILATION #PharmaFlow

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NEWS #PharmaBuzz

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Global Sales Information

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Finished Drug Prices

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01

Brand Name : Zoledronic acid Actavis

Ireland
arrow
Antibody Engineering
Not Confirmed

Brand Name : Zoledronic acid Actavis

Ireland
arrow
Antibody Engineering
Not Confirmed

Zoledronic Acid

Dosage Form : Concentrate to the infusion flui...

Dosage Strength : 4 mg/5 ml

Price Per Pack (Euro) : 175.97

Published in :

Country : Norway

RX/OTC/DISCN :

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02

Brand Name : Zoledronsyre Fresenius Kabi

Sweden
arrow
Antibody Engineering
Not Confirmed

Brand Name : Zoledronsyre Fresenius Kabi

Sweden
arrow
Antibody Engineering
Not Confirmed

Zoledronic Acid

Dosage Form : Concentrate to the infusion flui...

Dosage Strength : 4 mg/5 ml

Price Per Pack (Euro) : 175.97

Published in :

Country : Norway

RX/OTC/DISCN :

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03

Brand Name : Zoledronate Accord onco

United Kingdom
arrow
Antibody Engineering
Not Confirmed

Brand Name : Zoledronate Accord onco

United Kingdom
arrow
Antibody Engineering
Not Confirmed

Zoledronic Acid

Dosage Form : Inf Conc

Dosage Strength : 4mg/5ml

Price Per Pack (Euro) : 105.85

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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04

Brand Name : Zoledronate Fresenius Onco

Sweden
arrow
Antibody Engineering
Not Confirmed

Brand Name : Zoledronate Fresenius Onco

Sweden
arrow
Antibody Engineering
Not Confirmed

Zoledronic Acid

Dosage Form : Inf Conc

Dosage Strength : 4mg/5ml

Price Per Pack (Euro) : 98.47

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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05

Brand Name : Zoledronate Onco Labatec

Switzerland
arrow
Antibody Engineering
Not Confirmed

Brand Name : Zoledronate Onco Labatec

Switzerland
arrow
Antibody Engineering
Not Confirmed

Zoledronic Acid

Dosage Form : Inf Conc

Dosage Strength : 4mg/5ml

Price Per Pack (Euro) : 108.31

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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06

Brand Name : Zometa

Switzerland
arrow
Antibody Engineering
Not Confirmed

Brand Name : Zometa

Switzerland
arrow
Antibody Engineering
Not Confirmed

Zoledronic Acid

Dosage Form : Inf Conc

Dosage Strength : 4mg/5ml

Price Per Pack (Euro) : 165.83

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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07

Brand Name : Zoledronic acid Onco Sandoz

Switzerland
arrow
Antibody Engineering
Not Confirmed

Brand Name : Zoledronic acid Onco Sandoz

Switzerland
arrow
Antibody Engineering
Not Confirmed

Zoledronic Acid

Dosage Form : Inf Conc

Dosage Strength : 4mg/5ml

Price Per Pack (Euro) : 108.31

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

blank

08

Brand Name : Zoledronate-Teva onco

Israel
arrow
Antibody Engineering
Not Confirmed

Brand Name : Zoledronate-Teva onco

Israel
arrow
Antibody Engineering
Not Confirmed

Zoledronic Acid

Dosage Form : Inf Conc

Dosage Strength : 4mg/5ml

Price Per Pack (Euro) : 108.31

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

blank

09

Brand Name : Zoledronate Osteo Labatec

Switzerland
arrow
Antibody Engineering
Not Confirmed

Brand Name : Zoledronate Osteo Labatec

Switzerland
arrow
Antibody Engineering
Not Confirmed

Zoledronic Acid

Dosage Form : Inf L?s

Dosage Strength : 5mg/100ml

Price Per Pack (Euro) : 214.03

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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10

Brand Name : Zoledronate Osteo Sandoz

Switzerland
arrow
Antibody Engineering
Not Confirmed

Brand Name : Zoledronate Osteo Sandoz

Switzerland
arrow
Antibody Engineering
Not Confirmed

Zoledronic Acid

Dosage Form : Inf L?s

Dosage Strength : 5mg/100ml

Price Per Pack (Euro) : 214.03

Published in :

Country : Switzerland

RX/OTC/DISCN : Class B

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