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ACTIVE PHARMA INGREDIENTS

33 API Suppliers, 21 USDMF, 7 CEP/COS, 10 EU WC, 1 KDMF, 9 NDC API, 19 Listed Suppliers, $ API Reference Price

33 API Suppliers
21 USDMF
7 CEP/COS
10 EU WC
1 KDMF
9 NDC API
19 Listed Suppliers
$ API Reference Price

INTERMEDIATES

38 Intermediates Suppliers

38 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

156 FDF Dossiers, 41 FDA Orange Book, 86 Europe, 8 Canada, 12 Australia, 9 South Africa

156 FDF Dossiers
41 FDA Orange Book
86 Europe
8 Canada
12 Australia
9 South Africa

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 20MG BASE, CAPSULE;ORAL - EQ 40MG BASE, CAPSULE;ORAL - EQ 60MG BASE, CAPSULE;ORAL - EQ 80MG BASE

drugProductComposition
CAPSULE;ORAL - EQ 20MG BASE
CAPSULE;ORAL - EQ 40MG BASE
CAPSULE;ORAL - EQ 60MG BASE
CAPSULE;ORAL - EQ 80MG BASE

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 8 DKSH, 5 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 24 BASF, 1 Corel Pharma Chem, 6 DFE Pharma, 1 Doshion Polyscience, 2 Finar, 11 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 26 Kerry, 3 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 3 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qualicaps, 17 Roquette, 8 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders, 33 Direct Compression, 28 Thickeners and Stabilizers, 25 Solubilizers, 22 Disintegrants & Superdisintegrants, 21 Granulation, 19 Co-Processed Excipients, 17 Lubricants & Glidants, 15 Coating Systems & Additives, 15 Controlled & Modified Release, 14 Topical, 13 Parenteral, 13 Taste Masking, 9 Film Formers & Plasticizers, 8 Empty Capsules, 8 Emulsifying Agents, 5 Chewable & Orodispersible Aids, 3 Surfactant & Foaming Agents, 3 API Stability Enhancers, 3 Coloring Agents, 2 Rheology Modifiers, 1 Dry Powder Inhalation

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 6 NEWS #PharmaBuzz

media
1 DATA COMPILATION #PharmaFlow
6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 64 Finished Drug Prices

globalSalesInformation
1 US Medicaid Prescriptions
64 Finished Drug Prices

MARKET PLACE

4 APIs, 1 FDF Dossiers

marketPlace
4 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Exclusivities, 16 Health Canada Patents

patents
4 US Exclusivities
16 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 5 USP , 7 Others

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3 EDQM
5 USP
7 Others

Chemwerth Ziprasidone Hydrochloride

Synopsis

ACTIVE PHARMA INGREDIENTS

33

API Suppliers

21

USDMF

7

CEP/COS

CEP/COS Certifications

0

JDMF

10

EU WC

1

KDMF

9

NDC API

0

VMF

19

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 1,817

MARKET PLACE

4

API

1

FDF

38INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

156

FDF Dossiers

41

FDA Orange Book

FDA (Orange Book)

86

Europe

8

Canada

12

Australia

9

South Africa

0

Listed Dossiers

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

3

EDQM

5

USP

0

JP

7

Others

PATENTS & EXCLUSIVITIES

0

US Patents

4

US Exclusivities

16

Health Canada Patents

DIGITAL CONTENT

1

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

6

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

72,326,233

Annual Reports (USD Million)

NA

Finished Drug Prices

208 RELATED EXCIPIENT COMPANIES

347EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 122883-93-6, Ziprasidone hcl, Geodon, Zeldox, 5-(2-(4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)ethyl)-6-chloroindolin-2-one hydrochloride, Ziprasidone (hydrochloride)

Molecular Formula

C₂₁H₂₂Cl₂N₄OS

Molecular Weight

449.4 g/mol

InChI Key

NZDBKBRIBJLNNT-UHFFFAOYSA-N

FDA UNII

JAL53626GG

Ziprasidone Hydrochloride

Ziprasidone Hydrochloride is the hydrochloride salt form of ziprasidone, a benzothiazolylpiperazine derivative and an atypical antipsychotic agent with an antischizophrenic property. Ziprasidone hydrochloride functions as an antagonist at the dopamine D2 and serotonin 5-HT2A and 5-HT1D receptors, and as an agonist at the 5-HT1A receptor. Ziprasidone hydrochloride also inhibits synaptic reuptake of serotonin and norepinephrine. The mechanism of action by which ziprasidone hydrochloride exerts its antischizophrenic effect is unknown but is potentially mediated through a combination of dopamine D2 and serotonin 5-HT2 antagonism. This agent also has antagonistic activity against histamine H1 and alpha-1-adrenergic receptors.

1 2D Structure

Ziprasidone Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one;hydrochloride

2.1.2 InChI

InChI=1S/C21H21ClN4OS.ClH/c22-17-13-18-15(12-20(27)23-18)11-14(17)5-6-25-7-9-26(10-8-25)21-16-3-1-2-4-19(16)28-24-21;/h1-4,11,13H,5-10,12H2,(H,23,27);1H

2.1.3 InChI Key

NZDBKBRIBJLNNT-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CN(CCN1CCC2=C(C=C3C(=C2)CC(=O)N3)Cl)C4=NSC5=CC=CC=C54.Cl

2.2 Other Identifiers

2.2.1 UNII

JAL53626GG

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 5-(2-(4-(3-benzisothiazolyl)piperazinyl)ethyl)-6-chloro-1,3-dihydro-2h-indol-2-one

2. Cp 88059

3. Cp 88059-01

4. Cp-88,059

5. Cp-88,059-01

6. Cp-88,059-1

7. Geodon

8. Ziprasidone

9. Ziprasidone Hydrochloride, Monohydrate

10. Ziprazidone

2.3.2 Depositor-Supplied Synonyms

1. 122883-93-6

2. Ziprasidone Hcl

3. Geodon

4. Zeldox

5. 5-(2-(4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)ethyl)-6-chloroindolin-2-one Hydrochloride

6. Ziprasidone (hydrochloride)

7. 5-[2-[4-(1,2-benzisothiazol-3yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2h-indol-2-one Hydrochloride

8. Ziprasidone Hydrochloride [usan]

9. Jal53626gg

10. 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2h-indol-2-one Hydrochloride

11. 5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one Hydrochloride

12. Cp 88059 (hydrochloride Monohydrate)

13. 122883-93-6 (hcl)

14. 2h-indol-2-one, 5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-1,3-dihydro-, Monohydrochloride

15. 5-{2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl}-6-chloro-2,3-dihydro-1h-indol-2-one Hydrochloride

16. Cp 88059

17. Ziprasidone Hydrochloride Hydrate

18. C21h21cln4os.hcl

19. Unii-jal53626gg

20. Ziprasidone, Hcl

21. 2h-indol-2-one, 5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-1,3-dihydro-, Hydrochloride (1:1)

22. 2h-indol-2-one, 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-, Hydrochloride (1:1)

23. Cp-88059 Hydrochloride

24. Chembl1712

25. Mls006010221

26. Schembl122876

27. Dtxsid00153762

28. Hy-14542a

29. S1444

30. Akos015848366

31. Ac-7053

32. Ccg-220561

33. Cs-1887

34. Ks-1219

35. 5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one;hydrochloride

36. Ac-26998

37. Smr002204092

38. Ziprasidone Hydrochloride Anhydrous

39. Sw199027-2

40. Z0032

41. Ziprasidone Hydrochloride Anhydrous [mi]

42. 939z277

43. A890906

44. Sr-01000759387

45. Sr-01000759387-2

46. Ziprasidone Hydrochloride Anhydrous [who-dd]

47. Q27281411

48. 5-(2-(4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)ethyl)-6-chloroindolin-2-one Hcl

49. 5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-2-indolinone Monohydrochloride

50. 5-(2-(4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)-ethyl)-6-chloroindolin-2-one Hydrochloride

51. 5-[2-[4-(1,2-benzisothiazol-3-yl)-1 -piperazinyl]ethyl]-6-chloro-1,3-dihydro-2h-indol- 2-one Hydrochloride

52. 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1, 3-dihydro-2h-indol-2-one Hydrochloride

53. Ziprasidone Hydrochloride Solution, 1.0 Mg/ml In Methanol, Certified Reference Material, Ampule Of 1 Ml

2.4 Create Date

2005-08-09

3 Chemical and Physical Properties

Molecular Formula	C₂₁H₂₂Cl₂N₄OS
Molecular Weight	449.4 g/mol
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	4
Exact Mass	448.0891379 g/mol
Monoisotopic Mass	448.0891379 g/mol
Topological Polar Surface Area	76.7 Å²
Heavy Atom Count	29
Formal Charge	0
Complexity	573
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Ziprasidone hydrochloride
Drug Label	GEODON is available as capsules (ziprasidone hydrochloride) for oral administration and as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophen...
Active Ingredient	Ziprasidone hydrochloride
Dosage Form	Capsule
Route	Oral
Strength	eq 20mg base; eq 40mg base; eq 80mg base; eq 60mg base
Market Status	Prescription
Company	Mylan Pharms; Wockhardt; Apotex; Lupin Pharms; Sandoz; Dr Reddys Labs

2 of 2
Drug Name	Ziprasidone hydrochloride
Drug Label	GEODON is available as capsules (ziprasidone hydrochloride) for oral administration and as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophen...
Active Ingredient	Ziprasidone hydrochloride
Dosage Form	Capsule
Route	Oral
Strength	eq 20mg base; eq 40mg base; eq 80mg base; eq 60mg base
Market Status	Prescription
Company	Mylan Pharms; Wockhardt; Apotex; Lupin Pharms; Sandoz; Dr Reddys Labs

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antipsychotic Agents

Agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect. They are used in SCHIZOPHRENIA; senile dementia; transient psychosis following surgery; or MYOCARDIAL INFARCTION; etc. These drugs are often referred to as neuroleptics alluding to the tendency to produce neurological side effects, but not all antipsychotics are likely to produce such effects. Many of these drugs may also be effective against nausea, emesis, and pruritus. (See all compounds classified as Antipsychotic Agents.)

Serotonin Antagonists

Drugs that bind to but do not activate serotonin receptors, thereby blocking the actions of serotonin or SEROTONIN RECEPTOR AGONISTS. (See all compounds classified as Serotonin Antagonists.)

Dopamine Antagonists

Drugs that bind to but do not activate DOPAMINE RECEPTORS, thereby blocking the actions of dopamine or exogenous agonists. Many drugs used in the treatment of psychotic disorders (ANTIPSYCHOTIC AGENTS) are dopamine antagonists, although their therapeutic effects may be due to long-term adjustments of the brain rather than to the acute effects of blocking dopamine receptors. Dopamine antagonists have been used for several other clinical purposes including as ANTIEMETICS, in the treatment of Tourette syndrome, and for hiccup. Dopamine receptor blockade is associated with NEUROLEPTIC MALIGNANT SYNDROME. (See all compounds classified as Dopamine Antagonists.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Atypical Antipsychotic [EPC]

API SUPPLIERS

01

ChemWerth Inc

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Dr. Reddy's Laboratories

India

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Jai Radhe Sales

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HRV Global Life Sciences

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Dr. Reddy's Laboratories

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Wockhardt

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08

Raks Pharma

India

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09

RANBAXY LABORATORIES LIMITED

India

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10

Qilu Tianhe Pharmaceutical Co., Lt...

China

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Dr Reddys Laboratories Ltd

India

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Digital Content

Ziprasidone Hydrochloride Monohydrate

GDUFA

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DMF Number : 21147

Submission : 2007-12-17

Status : Active

Type : II

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Dr Reddys Laboratories Ltd

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Submission : 2004-12-23

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Type : II

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Amino Chemicals Ltd

Malta

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Apotex Pharmachem Inc

Canada

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06

Apitoria Pharma Private Ltd

India

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07

Lupin Ltd

India

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08

Ranbaxy Laboratories Ltd

India

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09

Wockhardt Ltd

India

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10

Zydus Lifesciences Ltd

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API Reference Price

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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 - CAPSULE;ORAL - EQ 20MG BASE

USFDA APPLICATION NUMBER - 20825

DOSAGE - CAPSULE;ORAL - EQ 40MG BASE

USFDA APPLICATION NUMBER - 20825

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USFDA APPLICATION NUMBER - 20825

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Patents & EXCLUSIVITIES

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US Exclusivities

01

VIATRIS

ZIPRASIDONE HYDROCHLORIDE

Medlab Asia & Asia Health

Not Confirmed

02

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ZIPRASIDONE HYDROCHLORIDE

Medlab Asia & Asia Health

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Medlab Asia & Asia Health

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VIATRIS

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Medlab Asia & Asia Health

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