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Chemistry

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Also known as: 903576-44-3, Ciproxidine, Bf 2649, Pitolisant hcl, Pitolisant (hydrochloride), Bf 2649 hydrochloride
Molecular Formula
C17H27Cl2NO
Molecular Weight
332.3  g/mol
InChI Key
XLFKECRRMPOAQS-UHFFFAOYSA-N
FDA UNII
YV33CH63HI

Pitolisant Hydrochloride
1 2D Structure

Pitolisant Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-[3-[3-(4-chlorophenyl)propoxy]propyl]piperidine;hydrochloride
2.1.2 InChI
InChI=1S/C17H26ClNO.ClH/c18-17-9-7-16(8-10-17)6-4-14-20-15-5-13-19-11-2-1-3-12-19;/h7-10H,1-6,11-15H2;1H
2.1.3 InChI Key
XLFKECRRMPOAQS-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CCN(CC1)CCCOCCCC2=CC=C(C=C2)Cl.Cl
2.2 Other Identifiers
2.2.1 UNII
YV33CH63HI
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 903576-44-3

2. Ciproxidine

3. Bf 2649

4. Pitolisant Hcl

5. Pitolisant (hydrochloride)

6. Bf 2649 Hydrochloride

7. Yv33ch63hi

8. Pitolisant Hydrochloride [usan]

9. 1-(3-(3-(4-chlorophenyl)propoxy)propyl)piperidine Hydrochloride

10. Piperidine, 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-, Hydrochloride

11. 903576-44-3 (hcl)

12. Wakix (tn)

13. Pitolisant Hydrochloride (usan)

14. 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine Hydrochloride

15. 1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine Hydrochloride

16. Piperidine, 1-(3-(3-(4-chlorophenyl)propoxy)propyl)-, Hydrochloride

17. Bf 2.649

18. Unii-yv33ch63hi

19. Schembl4591893

20. Bf-2649 Hydrochloride

21. Chembl4164059

22. Dtxsid50238098

23. Pitolisant;ciproxidine; Bf2649

24. Amy23423

25. Bcp16427

26. Ex-a1420

27. Hy-12199b

28. Pitolisant Hydrochloride [mi]

29. S5926

30. Akos024457784

31. Cs-1501

32. Sb17036

33. Pitolisant Hydrochloride [who-dd]

34. Ac-36017

35. As-72196

36. A3727

37. Pitolisant Hydrochloride [orange Book]

38. C77058

39. D11490

40. A900088

41. Q27895485

42. 1-[3-[3-(4-chlorophenyl)propoxy]propyl]piperidine;hydrochloride

43. 1-(3-(3-(4-chlorophenyl)propoxy)propyl)piperidine Monohydrochloride

44. Piperidine, 1-(3-(3-(4-chlorophenyl)propoxy)propyl)-, Hydrochloride (1:1)

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 332.3 g/mol
Molecular Formula C17H27Cl2NO
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count2
Rotatable Bond Count8
Exact Mass331.1469699 g/mol
Monoisotopic Mass331.1469699 g/mol
Topological Polar Surface Area12.5 Ų
Heavy Atom Count21
Formal Charge0
Complexity235
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

API SUPPLIERS

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HRV Global Life Sciences

India

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Nuray Chemicals Private Limited

India

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Biophore India Pharmaceuticals Pvt...

India

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Nuray Chemicals Private Limited

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Emnar Pharma

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MSN Laboratories

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Virchow Group

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Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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Pitolisant Hydrochloride

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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Pitolisant Hydrochloride

About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...

Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in the Indian state of Tamil Nadu. Nuray’s expertise and experience lie in developing the chemistry requirements of the pharmaceutical industry, including the synthesis of NCEs, impurities, metabolites, method development, advanced intermediates and APIs for commercial launch. With its focus on maintaining the highest levels of quality, reliability and transparency, Nuray has emerged as a trusted partner in the global generic market.
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Emnar Pharma

India
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Emnar Pharma

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Pitolisant Hydrochloride

About the Company : Emnar Pharma was established in 2005, with a drive to become the premier integrated pharmaceuticals company in India. Its business focuses on Contract Manufacturing, Custom Synthes...

Emnar Pharma was established in 2005, with a drive to become the premier integrated pharmaceuticals company in India. Its business focuses on Contract Manufacturing, Custom Synthesis, and the manufacture and marketing of pharmaceutical products and services to clients across the globe. Its product portfolio includes a range of Active Pharmaceutical Ingredients (APIs), Fine Intermediates, and CRAMS.
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Pitolisant Hydrochloride

About the Company : Virchow Group comprises of six active pharmaceutical ingredient (API) and drug intermediate manufacturing units and two biotech units. Incorporated in 1981, the flagship company of...

Virchow Group comprises of six active pharmaceutical ingredient (API) and drug intermediate manufacturing units and two biotech units. Incorporated in 1981, the flagship company of the group, Virchow Laboratories Limited is today the largest producer of Sulfamethoxazole in the world. In fact, Virchow Group services more than 80% of the worldwide Sulfamethoxazole requirement. Other group companies are leading manufacturers of Ranitidine, Cephalosporins and various other APIs and bio-pharmaceuticals. Virchow also undertakes custom synthesis and manufacture of drug intermediates.
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Drugs in Development

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Details:

Wakix (pitolisant) is an oral H3 receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of narcolepsy in pediatric patients 6 years of age and older.


Lead Product(s): Pitolisant Hydrochloride

Therapeutic Area: Sleep Brand Name: Wakix

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 24, 2024

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01

Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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Details : Wakix (pitolisant) is an oral H3 receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of narcolepsy in pediatric patients 6 years of age and older.

Brand Name : Wakix

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 24, 2024

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Details:

Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.


Lead Product(s): Pitolisant Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Wakix

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 03, 2024

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02

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
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Details : Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.

Brand Name : Wakix

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 03, 2024

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Details:

Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.


Lead Product(s): Pitolisant Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Wakix

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 20, 2024

blank

03

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Wakix (pitolisant) is an oral histamine-3 (H3) receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of Prader-Willi syndrome.

Brand Name : Wakix

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 20, 2024

blank

Details:

Wakix (pitolisant HCl) is a 5-HT3 receptor Inhibitor Small molecule drug candidate, which is currently being evaluated for the treatment of adult patients with myotonic dystrophy type 1.


Lead Product(s): Pitolisant Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Wakix

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 07, 2023

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04

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Wakix (pitolisant HCl) is a 5-HT3 receptor Inhibitor Small molecule drug candidate, which is currently being evaluated for the treatment of adult patients with myotonic dystrophy type 1.

Brand Name : Wakix

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 07, 2023

blank

Details:

Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for idiopathic hypersomnia.


Lead Product(s): Pitolisant Hydrochloride

Therapeutic Area: Sleep Brand Name: Wakix

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 13, 2023

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05

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for idiopathic hypersomnia.

Brand Name : Wakix

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 13, 2023

blank

Details:

Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for idiopathic hypersomnia.


Lead Product(s): Pitolisant Hydrochloride

Therapeutic Area: Sleep Brand Name: Wakix

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 07, 2023

blank

06

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for idiopathic hypersomnia.

Brand Name : Wakix

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 07, 2023

blank

Details:

Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for Prader-Willi Syndrome.


Lead Product(s): Pitolisant Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Wakix

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 20, 2023

blank

07

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse and is being investigated for Prader-Willi Syndrome.

Brand Name : Wakix

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 20, 2023

blank

Details:

Wakix (pitolisant) is a selective histamine 3 (H3) receptor antagonist/inverse agonist, which was granted orphan drug designation for the treatment of narcolepsy by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).


Lead Product(s): Pitolisant Hydrochloride

Therapeutic Area: Sleep Brand Name: Wakix

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 04, 2023

blank

08

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Wakix (pitolisant) is a selective histamine 3 (H3) receptor antagonist/inverse agonist, which was granted orphan drug designation for the treatment of narcolepsy by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA).

Brand Name : Wakix

Molecule Type : Small molecule

Upfront Cash : Not Applicable

July 04, 2023

blank

Details:

Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse, which is used for Prader-Willi Syndrome.


Lead Product(s): Pitolisant Hydrochloride

Therapeutic Area: Genetic Disease Brand Name: Wakix

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 06, 2023

blank

09

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse, which is used for Prader-Willi Syndrome.

Brand Name : Wakix

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 06, 2023

blank

Details:

Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse.


Lead Product(s): Pitolisant Hydrochloride

Therapeutic Area: Sleep Brand Name: Wakix

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 25, 2023

blank

10

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : Wakix (pitolisant hydrochloride) enhances the activity of histaminergic neurons and promotes wakefulness by blocking H3 autoreceptors and increasing the levels of histamine transmitters at the synapse.

Brand Name : Wakix

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 25, 2023

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FDA Orange Book

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PITOLISANT HYDROCHLORIDE

Brand Name : WAKIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 4.45MG BASE

Approval Date : 2019-08-14

Application Number : 211150

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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PITOLISANT HYDROCHLORIDE

Brand Name : WAKIX

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 17.8MG BASE

Approval Date : 2019-08-14

Application Number : 211150

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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ENDO OPERATIONS LTD.

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PITOLISANT HYDROCHLORIDE

Brand Name : WAKIX

Dosage Form : TABLET

Dosage Strength : 5MG

Packaging :

Approval Date :

Application Number : 2516241

Regulatory Info : Prescription

Registration Country : Canada

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PITOLISANT HYDROCHLORIDE

Brand Name : WAKIX

Dosage Form : TABLET

Dosage Strength : 20MG

Packaging :

Approval Date :

Application Number : 2516268

Regulatory Info : Prescription

Registration Country : Canada

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Patents & EXCLUSIVITIES

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US Patents

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PITOLISANT HYDROCHLORIDE

US Patent Number : 8354430

Drug Substance Claim :

Drug Product Claim :

Application Number : 211150

Patent Use Code : U-1101

Delist Requested :

Patent Use Description : METHOD OF TREATING EXC...

Patent Expiration Date : 2026-02-06

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PITOLISANT HYDROCHLORIDE

US Patent Number : 8207197

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 211150

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-03-07

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PITOLISANT HYDROCHLORIDE

US Patent Number : 8207197

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 211150

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-03-07

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PITOLISANT HYDROCHLORIDE

US Patent Number : 8486947

Drug Substance Claim :

Drug Product Claim :

Application Number : 211150

Patent Use Code : U-1102

Delist Requested :

Patent Use Description : METHOD OF TREATING CAT...

Patent Expiration Date : 2029-09-26

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PITOLISANT HYDROCHLORIDE

US Patent Number : 8486947

Drug Substance Claim :

Drug Product Claim :

Application Number : 211150

Patent Use Code : U-1102

Delist Requested :

Patent Use Description : METHOD OF TREATING CAT...

Patent Expiration Date : 2029-09-26

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PITOLISANT HYDROCHLORIDE

US Patent Number : 8354430

Drug Substance Claim :

Drug Product Claim :

Application Number : 211150

Patent Use Code : U-1102

Delist Requested :

Patent Use Description : METHOD OF TREATING CAT...

Patent Expiration Date : 2026-02-06

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PITOLISANT HYDROCHLORIDE

US Patent Number : 8354430

Drug Substance Claim :

Drug Product Claim :

Application Number : 211150

Patent Use Code : U-1101

Delist Requested :

Patent Use Description : METHOD OF TREATING EXC...

Patent Expiration Date : 2026-02-06

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PITOLISANT HYDROCHLORIDE

US Patent Number : 8354430

Drug Substance Claim :

Drug Product Claim :

Application Number : 211150

Patent Use Code : U-1102

Delist Requested :

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US Patent Number : 8486947

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Application Number : 211150

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