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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 13 USDMF, 6 CEP/COS, 3 JDMF, 1 EU WC, 6 NDC API, 12 Listed Suppliers, $ API Reference Price

26 API Suppliers
13 USDMF
6 CEP/COS
3 JDMF
1 EU WC
6 NDC API
12 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

26 FDF Dossiers, 14 FDA Orange Book, 6 Europe, 1 Canada, 1 Australia, 2 South Africa, 2 Listed Dossiers

26 FDF Dossiers
14 FDA Orange Book
6 Europe
1 Canada
1 Australia
2 South Africa
2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - 200 IU/ML, SPRAY, METERED;NASAL - 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
INJECTABLE;INJECTION - 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - 200 IU/ML
SPRAY, METERED;NASAL - 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 12 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
12 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 8 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
8 Finished Drug Prices

MARKET PLACE

8 APIs, 3 FDF Dossiers

marketPlace
8 APIs
3 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM , 3 USP , 2 JP , 7 Others

otherSolutions
3 EDQM
3 USP
2 JP
7 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 4,928,630

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

1DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

980,104

Annual Reports (USD Million)

Finished Drug Prices

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Calcitonin-salmon, Thyrocalcitonin (salmon), Cibacalcin, Calcitonina, Calcitar, Bionocalcin

Molecular Formula

C₁₄₅H₂₄₀N₄₄O₄₈S₂

Molecular Weight

3431.9 g/mol

InChI Key

BBBFJLBPOGFECG-VJVYQDLKSA-N

Synthetic peptide, 32 residues long formulated as a nasal spray.

1 2D Structure

Calcitonin

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(4S)-4-[[(2S)-5-amino-2-[[(2S)-2-[[(2S)-2-[[(2S)-6-amino-2-[[2-[[(2S)-2-[[(2S)-2-[[(4R,7S,10S,13S,16S,19S,22R)-22-amino-16-(2-amino-2-oxoethyl)-7-[(1R)-1-hydroxyethyl]-10,19-bis(hydroxymethyl)-13-(2-methylpropyl)-6,9,12,15,18,21-hexaoxo-1,2-dithia-5,8,11,14,17,20-hexazacyclotricosane-4-carbonyl]amino]-3-methylbutanoyl]amino]-4-methylpentanoyl]amino]acetyl]amino]hexanoyl]amino]-4-methylpentanoyl]amino]-3-hydroxypropanoyl]amino]-5-oxopentanoyl]amino]-5-[[(2S)-1-[[(2S)-1-[[(2S)-6-amino-1-[[(2S)-1-[[(2S)-5-amino-1-[[(2S,3R)-1-[[(2S)-1-[(2S)-2-[[(2S)-1-[[(2S,3R)-1-[[(2S)-4-amino-1-[[(2S,3R)-1-[[2-[[(2S)-1-[[2-[[(2S,3R)-1-[(2S)-2-carbamoylpyrrolidin-1-yl]-3-hydroxy-1-oxobutan-2-yl]amino]-2-oxoethyl]amino]-3-hydroxy-1-oxopropan-2-yl]amino]-2-oxoethyl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1,4-dioxobutan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-5-carbamimidamido-1-oxopentan-2-yl]carbamoyl]pyrrolidin-1-yl]-3-(4-hydroxyphenyl)-1-oxopropan-2-yl]amino]-3-hydroxy-1-oxobutan-2-yl]amino]-1,5-dioxopentan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-1-oxohexan-2-yl]amino]-3-(1H-imidazol-5-yl)-1-oxopropan-2-yl]amino]-4-methyl-1-oxopentan-2-yl]amino]-5-oxopentanoic acid

2.1.2 InChI

InChI=1S/C145H240N44O48S2/c1-65(2)45-86(175-139(232)110(70(11)12)183-136(229)99-63-239-238-62-79(148)117(210)178-96(59-191)134(227)174-92(52-104(151)202)131(224)172-90(49-69(9)10)129(222)180-98(61-193)135(228)187-114(74(16)197)142(235)181-99)118(211)158-55-106(204)162-80(25-18-20-40-146)120(213)169-89(48-68(7)8)128(221)179-97(60-192)133(226)167-83(34-37-102(149)200)122(215)165-85(36-39-109(207)208)123(216)171-88(47-67(5)6)127(220)173-91(51-77-54-156-64-161-77)130(223)164-81(26-19-21-41-147)121(214)170-87(46-66(3)4)126(219)166-84(35-38-103(150)201)125(218)186-113(73(15)196)141(234)177-94(50-76-30-32-78(199)33-31-76)143(236)189-44-24-29-101(189)137(230)168-82(27-22-42-157-145(154)155)124(217)185-112(72(14)195)140(233)176-93(53-105(152)203)132(225)184-111(71(13)194)138(231)160-56-107(205)163-95(58-190)119(212)159-57-108(206)182-115(75(17)198)144(237)188-43-23-28-100(188)116(153)209/h30-33,54,64-75,79-101,110-115,190-199H,18-29,34-53,55-63,146-148H2,1-17H3,(H2,149,200)(H2,150,201)(H2,151,202)(H2,152,203)(H2,153,209)(H,156,161)(H,158,211)(H,159,212)(H,160,231)(H,162,204)(H,163,205)(H,164,223)(H,165,215)(H,166,219)(H,167,226)(H,168,230)(H,169,213)(H,170,214)(H,171,216)(H,172,224)(H,173,220)(H,174,227)(H,175,232)(H,176,233)(H,177,234)(H,178,210)(H,179,221)(H,180,222)(H,181,235)(H,182,206)(H,183,229)(H,184,225)(H,185,217)(H,186,218)(H,187,228)(H,207,208)(H4,154,155,157)/t71-,72-,73-,74-,75-,79+,80+,81+,82+,83+,84+,85+,86+,87+,88+,89+,90+,91+,92+,93+,94+,95+,96+,97+,98+,99+,100+,101+,110+,111+,112+,113+,114+,115+/m1/s1

2.1.3 InChI Key

BBBFJLBPOGFECG-VJVYQDLKSA-N

2.1.4 Canonical SMILES

CC(C)CC1C(=O)NC(C(=O)NC(C(=O)NC(CSSCC(C(=O)NC(C(=O)NC(C(=O)N1)CC(=O)N)CO)N)C(=O)NC(C(C)C)C(=O)NC(CC(C)C)C(=O)NCC(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CO)C(=O)NC(CCC(=O)N)C(=O)NC(CCC(=O)O)C(=O)NC(CC(C)C)C(=O)NC(CC2=CN=CN2)C(=O)NC(CCCCN)C(=O)NC(CC(C)C)C(=O)NC(CCC(=O)N)C(=O)NC(C(C)O)C(=O)NC(CC3=CC=C(C=C3)O)C(=O)N4CCCC4C(=O)NC(CCCNC(=N)N)C(=O)NC(C(C)O)C(=O)NC(CC(=O)N)C(=O)NC(C(C)O)C(=O)NCC(=O)NC(CO)C(=O)NCC(=O)NC(C(C)O)C(=O)N5CCCC5C(=O)N)C(C)O)CO

2.1.5 Isomeric SMILES

C[C@H]([C@H]1C(=O)N[C@@H](CSSC[C@@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N[C@H](C(=O)N1)CO)CC(C)C)CC(=O)N)CO)N)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC(C)C)C(=O)NCC(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CO)C(=O)N[C@@H](CCC(=O)N)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CC2=CN=CN2)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCC(=O)N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC3=CC=C(C=C3)O)C(=O)N4CCC[C@H]4C(=O)N[C@@H](CCCNC(=N)N)C(=O)N[C@@H]([C@@H](C)O)C(=O)N[C@@H](CC(=O)N)C(=O)N[C@@H]([C@@H](C)O)C(=O)NCC(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H]([C@@H](C)O)C(=O)N5CCC[C@H]5C(=O)N)O

2.2 Synonyms

2.2.1 MeSH Synonyms

1. Calcihexal

2. Calcimar

3. Calcitonin Salmon

4. Forcaltonin

5. Fortical

6. Miacalcic

7. Miacalcin

8. Recombinant Salmon Calcitonin

9. Salcatonin

10. Salmon Calcitonin (1-32)

11. Synthetic Salmon Calcitonin

2.2.2 Depositor-Supplied Synonyms

1. Calcitonin-salmon

2. Thyrocalcitonin (salmon)

3. Cibacalcin

4. Calcitonina

5. Calcitar

6. Bionocalcin

7. Calcimonta

8. Calcitoran

9. Cibacalcine

10. Eptacalcin

11. Miracalcic

12. Osseocalcina

13. Ostostabil

14. Porostenina

15. Prontocalcin

16. Rulicalcin

17. Salmocalcin

18. Salmotonin

19. Tonocalcin

20. Astronin

21. Biocalcin

22. Calciben

23. Calcinil

24. Calcioton

25. Calogen

26. Calsynar

27. Caltine

28. Catonin

29. Citonina

30. Ipocalcin

31. Kalsimin

32. Oseototal

33. Osteobion

34. Osteovis

35. Ostosalm

36. Quosten

37. Riostin

38. Salcatyn

39. Salmofar

40. Stalcin

41. Staporos

42. Steocin

43. Cadens

44. Casalm

45. Ostora

46. Salcat

47. Ucecal

48. Calco

49. Karil

50. Sical

51. Isi-calcin

52. Calcitonin,salmon

53. Calsynar Lyo L

54. Calcitonin(salmon)

55. Calcitonin, Salmar

56. Salmon Calcitonin I

57. Calcitonin Vom Lachs

58. Calcitonine De Saumon

59. Tz-ct

60. Unii-7sfc6u2vi5

61. Salmon Calcitonin-(i-32)

62. 7sfc6u2vi5

63. Salmon Calcitonin-(1-32)

64. Chebi:3306

65. Calcitonin, Salmon, For Bioassay

66. Dtxsid601026667

67. Calcitonin [usan:inn:ban:jan]

68. Einecs 256-342-8

69. Ncgc00167232-01

70. Calcitonin Salmon, >=97% (hplc), Powder

71. Calcitonin Salmon, European Pharmacopoeia (ep) Reference Standard

72. Calcitonin Salmon, United States Pharmacopeia (usp) Reference Standard

73. Cyclo-[cys-ser-asn-leu-ser-thr-cys]-val-leu-gly-lys-leu-ser-gln-glu-leu-his-lys-leu-gln-thr-tyr-pro-arg-thr-asn-thr-gly-ser-gly-thr-pro-nh2

2.3 Create Date

2007-07-16

3 Chemical and Physical Properties

Molecular Formula	C₁₄₅H₂₄₀N₄₄O₄₈S₂
Molecular Weight	3431.9 g/mol
XLogP3	-16.6
Hydrogen Bond Donor Count	52
Hydrogen Bond Acceptor Count	55
Rotatable Bond Count	99
Exact Mass	3430.7166627 g/mol
Monoisotopic Mass	3429.7133079 g/mol
Topological Polar Surface Area	1560 Å²
Heavy Atom Count	239
Formal Charge	0
Complexity	7970
Isotope Atom Count	0
Defined Atom Stereocenter Count	34
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Indication

Used in the treatment of symptomatic Paget's disease for patients unresponsive to alternate treatments or intolerant to such treatments. In addition, it is used in emergency situations when serum calcium levels must be decreased quickly until the underlying condition is identified. It can also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents. Calcitonin can be used in patients with azotemia and cases where intravenous fluids would be contraindicated due to limited cardiac reserves. Also for the treatment of post-menopausal osteoporosis in women more than 5 years post-menopause.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Calcitonin inhibits bone resorption by osteoclasts (bone remodeling cells) and promotes bone formation by osteoblasts. This leads to a net increase in bone mass and a reduction in plasma calcium levels. It also promotes the renal excretion of ions such as calcium, phosphate, sodium, magnesium, and potassium by decreasing tubular reabsorption. In consequence, there is an increase in the jejunal secretion of water, sodium, potassium, and chloride.

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.)

Calcium-Regulating Hormones and Agents

Hormones and molecules with calcium-regulating hormone-like actions that modulate OSTEOLYSIS and other extra-skeletal activities to maintain calcium homeostasis. (See all compounds classified as Calcium-Regulating Hormones and Agents.)

5.3 Absorption, Distribution and Excretion

Absorption

Salmon calcitonin is rapidly absorbed with bioavailability of 71% following subcutaneous injection and 66% following intramuscular injection in humans. Via the nasal route, the bioavailability varies between 3 to 5% relative to IM.

Route of Elimination

Urine. Studies with injectable calcitonin show increases in the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption in the kidney.

Volume of Distribution

0.15 to 0.3 L/kg

5.4 Metabolism/Metabolites

Salmon calcitonin primarily undergoes degradation in the kidneys to form pharmacologically inactive metabolites. It is also metabolized in the blood and the peripheral tissue.

5.5 Biological Half-Life

Half-life elimination (terminal): I.M. 58 minutes; SubQ 59 to 64 minutes; Nasal: ~18 to 23 minutes

5.6 Mechanism of Action

Calcitonin binds to the calcitonin receptor (found primarily in osteoclasts) which then enhances the production of vitamin D producing enzymes (25-hydroxyvitamine D-24-hydroxylase), leading to greater calcium retention and enhanced bone density. Binding of calcitonin to its receptor also activates adenylyl cyclase and the phosphatidyl-inositol-calcium pathway.

API SUPPLIERS

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USDMF

01

Aventis Behring Gmbh

France

Compamed

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

Hplc Purified Calcitonin-salmon Drug Substance

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 7484

Submission : 1988-05-10

Status : Inactive

Type : II

Portfolio PDF

Product Web Link

02

Bachem Americas Inc

Switzerland

TIDES Europe 2024

Sponsor

Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.

Contact Supplier

Switzerland

Virtual Booth

Digital Content

Salmon Calcitonin (sct)

GDUFA

DMF Review : Complete

Rev. Date : 2015-03-27

Pay. Date : 2015-03-18

DMF Number : 6504

Submission : 1986-07-29

Status : Active

Type : II

03

Iaf Biochem International Inc

United Kingdom

Compamed

Not Confirmed

04

Mallinckrodt Chemical Inc

Ireland

Compamed

Not Confirmed

05

Peninsula Labs Inc

U.S.A

Compamed

Not Confirmed

06

Polypeptide Laboratories As

Switzerland

Compamed

Not Confirmed

07

Ucb Bioproducts Sa

Belgium

Compamed

Not Confirmed

08

Ugp Therapeutics Inc

Egypt

Compamed

Not Confirmed

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API Reference Price

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DOSAGE - INJECTABLE;INJECTION - 100 IU/ML **F...DOSAGE - INJECTABLE;INJECTION - 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 17808

DOSAGE - INJECTABLE;INJECTION - 200 IU/ML

USFDA APPLICATION NUMBER - 17808

DOSAGE - SPRAY, METERED;NASAL - 200 IU/SPRAY ...DOSAGE - SPRAY, METERED;NASAL - 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20313

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INJECTABLE;INJECTION - 100 IU/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

SPRAY, METERED;NASAL - 200 IU/SPRAY Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons