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Hydroxyzine Pamoate

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 7 USDMF, 1 JDMF, 7 NDC API, 5 Listed Suppliers, $ API Reference Price

10 API Suppliers
7 USDMF
1 JDMF
7 NDC API
5 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

41 FDF Dossiers, 41 FDA Orange Book

41 FDF Dossiers
41 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 25MG HYDROCHLORIDE, CAPSULE;ORAL - EQ 50MG HYDROCHLORIDE

drugProductComposition
CAPSULE;ORAL - EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE;ORAL - EQ 25MG HYDROCHLORIDE
CAPSULE;ORAL - EQ 50MG HYDROCHLORIDE

RELATED EXCIPIENT COMPANIES

6 DKSH, 4 ACG Worldwide, 1 Gangwal Chemicals, 3 Lonza Capsugel, 1 Qualicaps, 2 Roquette

relatedExcipients
6 DKSH
4 ACG Worldwide
1 Gangwal Chemicals
3 Lonza Capsugel
1 Qualicaps
2 Roquette

EXCIPIENTS BY APPLICATIONS

8 Empty Capsules, 5 Coating Systems & Additives, 4 Thickeners and Stabilizers, 4 Fillers, Diluents & Binders, 2 Coloring Agents, 2 Film Formers & Plasticizers, 1 Taste Masking

excipientsByApplications
8 Empty Capsules
5 Coating Systems & Additives
4 Thickeners and Stabilizers
4 Fillers, Diluents & Binders
2 Coloring Agents
2 Film Formers & Plasticizers
1 Taste Masking

DIGITAL CONTENT

1 NEWS #PharmaBuzz

media
1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

globalSalesInformation
2 US Medicaid Prescriptions

MARKET PLACE

3 FDF Dossiers

marketPlace
3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 USP , 1 Others

otherSolutions
1 USP
1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 188

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

0 DRUGS 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)

18,127,362

Annual Reports (USD Million)

Finished Drug Prices

17 RELATED EXCIPIENT COMPANIES

26EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 10246-75-0, Hydroxyzine embonate, Bobsule, Hydroxyzine (pamoate), Equipose, Hydroxyzine pamoate salt

Molecular Formula

C₄₄H₄₃ClN₂O₈

Molecular Weight

763.3 g/mol

InChI Key

ASDOKGIIKXGMNB-UHFFFAOYSA-N

FDA UNII

M20215MUFR

A histamine H1 receptor antagonist that is effective in the treatment of chronic urticaria, dermatitis, and histamine-mediated pruritus. Unlike its major metabolite CETIRIZINE, it does cause drowsiness. It is also effective as an antiemetic, for relief of anxiety and tension, and as a sedative.

1 2D Structure

Hydroxyzine Pamoate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-[(3-carboxy-2-hydroxynaphthalen-1-yl)methyl]-3-hydroxynaphthalene-2-carboxylic acid;2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol

2.1.2 InChI

InChI=1S/C23H16O6.C21H27ClN2O2/c24-20-16(14-7-3-1-5-12(14)9-18(20)22(26)27)11-17-15-8-4-2-6-13(15)10-19(21(17)25)23(28)29;22-20-8-6-19(7-9-20)21(18-4-2-1-3-5-18)24-12-10-23(11-13-24)14-16-26-17-15-25/h1-10,24-25H,11H2,(H,26,27)(H,28,29);1-9,21,25H,10-17H2

2.1.3 InChI Key

ASDOKGIIKXGMNB-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CN(CCN1CCOCCO)C(C2=CC=CC=C2)C3=CC=C(C=C3)Cl.C1=CC=C2C(=C1)C=C(C(=C2CC3=C(C(=CC4=CC=CC=C43)C(=O)O)O)O)C(=O)O

2.2 Other Identifiers

2.2.1 UNII

M20215MUFR

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)ethanol

2. Atarax

3. Durrax

4. Hydroxyzine

5. Hydroxyzine Dihydrochloride

6. Hydroxyzine Hydrochloride

7. Orgatrax

8. Pamoate, Hydroxyzine

9. Vistaril

2.3.2 Depositor-Supplied Synonyms

1. 10246-75-0

2. Hydroxyzine Embonate

3. Bobsule

4. Hydroxyzine (pamoate)

5. Equipose

6. Hydroxyzine Pamoate Salt

7. Hy-pam

8. Nsc-757063

9. Mls000028605

10. M20215mufr

11. Masmoran

12. Paxisitil

13. Smr000058728

14. Atarax P

15. 4-[(3-carboxy-2-hydroxynaphthalen-1-yl)methyl]-3-hydroxynaphthalene-2-carboxylic Acid;2-[2-[4-[(4-chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol

16. Sr-01000003149

17. Einecs 233-582-1

18. Unii-m20215mufr

19. Hydroxyzine Pamoate [usp:jan]

20. Atarax-p (tn)

21. Spectrum_000911

22. Vistaril Pamoate (tn)

23. Spectrum2_001000

24. Spectrum3_000463

25. Spectrum4_000013

26. Spectrum5_000838

27. Hyydroxyzine Pamoate

28. 6-ethylthiomorpholin-3-one

29. Schembl41333

30. Bspbio_002166

31. Kbiogr_000385

32. Kbioss_001391

33. 2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol 4,4'-methylenebis(3-hydroxy-2-naphthoate) (1:1)

34. Divk1c_000503

35. Spectrum1500345

36. Spbio_001099

37. Chembl1200467

38. Hydroxyzine Pamoate [mi]

39. Hms501j05

40. Kbio1_000503

41. Kbio2_001391

42. Kbio2_003959

43. Kbio2_006527

44. Kbio3_001386

45. Dtxsid00907580

46. Hydroxyzine Pamoate [jan]

47. Hydroxyzine Pamoate (jp17/usp)

48. Ninds_000503

49. Hms1920f11

50. Hms2091l19

51. Hms2235o19

52. Hms3886g14

53. Pharmakon1600-01500345

54. Hydroxyzine Pamoate [vandf]

55. Hy-b0895

56. Ccg-40218

57. Hydroxyzine Embonate [mart.]

58. Hydroxyzine Pamoate [usp-rs]

59. Mfcd00058051

60. Nsc757063

61. S5649

62. Hydroxyzine Embonate [who-dd]

63. Akos015914218

64. Nsc 757063

65. Idi1_000503

66. Hydroxyzine Pamoate [orange Book]

67. Ncgc00021152-02

68. Ncgc00021152-03

69. Ncgc00094698-01

70. Ncgc00094698-02

71. (+-)-2-(2-(4-(p-chloro-alpha-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol 4,4'-methylenebis(3-hydroxy-2-naphthoate) (1:1)

72. Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, (+-)-, Compd. With 4,4'-methylenebis(3-hydroxy-2-naphthalenecarboxylic Acid) (1:1)

73. Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, Compd. With 4,4'-methylenebis(3-hydroxy-2-naphthalenecarboxylic Acid) (1:1)

74. Hydroxyzine Pamoate [usp Monograph]

75. Sbi-0051413.p003

76. Ft-0697190

77. Hydroxyzine Pamoate Salt, Analytical Standard

78. D01096

79. F15112

80. J-000695

81. Sr-01000003149-2

82. Sr-01000003149-4

83. Q27114645

84. Hydroxyzine Pamoate, United States Pharmacopeia (usp) Reference Standard

85. (+/-)-2-(2-(4-(p-chloro-.alpha.-phenylbenzyl)-1-piperazinyl)ethoxy)ethanol 4,4'-methylenebis(3-hydroxy-2-naphthoate) (1:1)

86. Ethanol, 2-(2-(4-((4-chlorophenyl)phenylmethyl)-1-piperazinyl)ethoxy)-, (+/-)-, Compd. With 4,4'-methylenebis(3-hydroxy-2-naphthalenecarboxylic Acid) (1:1)

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₄₄H₄₃ClN₂O₈
Molecular Weight	763.3 g/mol
Hydrogen Bond Donor Count	5
Hydrogen Bond Acceptor Count	10
Rotatable Bond Count	12
Exact Mass	762.2707940 g/mol
Monoisotopic Mass	762.2707940 g/mol
Topological Polar Surface Area	151 Å²
Heavy Atom Count	55
Formal Charge	0
Complexity	945
Isotope Atom Count	0
Defined Atom Stereocenter Count	0
Undefined Atom Stereocenter Count	1
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	Hydroxyzine pamoate
PubMed Health	Hydroxyzine Pamoate (By mouth)
Drug Classes	Antianxiety, Antiemetic, Respiratory Agent
Drug Label	Hydroxyzine pamoate is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1'-methylene bis (2 hydroxy-3-naphthalene carboxylic acid). It has the following structural formula: C21H27ClN2O2C23H1...
Active Ingredient	Hydroxyzine pamoate
Dosage Form	Capsule
Route	Oral
Strength	eq 50mg hydrochloride; eq 50mg hcl; eq 100mg hcl; eq 25mg hcl; eq 25mg hydrochloride
Market Status	Prescription
Company	Sandoz; Watson Labs; Emcure Pharms Usa; Barr

2 of 2
Drug Name	Hydroxyzine pamoate
PubMed Health	Hydroxyzine Pamoate (By mouth)
Drug Classes	Antianxiety, Antiemetic, Respiratory Agent
Drug Label	Hydroxyzine pamoate is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1'-methylene bis (2 hydroxy-3-naphthalene carboxylic acid). It has the following structural formula: C21H27ClN2O2C23H1...
Active Ingredient	Hydroxyzine pamoate
Dosage Form	Capsule
Route	Oral
Strength	eq 50mg hydrochloride; eq 50mg hcl; eq 100mg hcl; eq 25mg hcl; eq 25mg hydrochloride
Market Status	Prescription
Company	Sandoz; Watson Labs; Emcure Pharms Usa; Barr

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Histamine H1 Antagonists

Drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine. Included here are the classical antihistaminics that antagonize or prevent the action of histamine mainly in immediate hypersensitivity. They act in the bronchi, capillaries, and some other smooth muscles, and are used to prevent or allay motion sickness, seasonal rhinitis, and allergic dermatitis and to induce somnolence. The effects of blocking central nervous system H1 receptors are not as well understood. (See all compounds classified as Histamine H1 Antagonists.)

Antipruritics

Agents, usually topical, that relieve itching (pruritus). (See all compounds classified as Antipruritics.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Histamine Receptor Antagonists [MoA]; Antihistamine [EPC]

API SUPPLIERS

01

Symed Labs

India

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

BIO Partnering at JPM

Not Confirmed

02

COSMA S.p.A

Italy

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

BIO Partnering at JPM

Not Confirmed

03

Ramdev Chemicals Pvt Ltd

India

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

BIO Partnering at JPM

Not Confirmed

04

Napp Technologies

U.S.A

India

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

BIO Partnering at JPM

Not Confirmed

Belgium

Biotech Showcase

Not Confirmed

India

BIO Partnering at JPM

Not Confirmed

06

SYMED LABS LIMITED

India

BIO Partnering at JPM

Not Confirmed

07

Uquifa Spain

Spain

BIO Partnering at JPM

Not Confirmed

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

API Reference Price

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A.","supplierCountry":"ITALY","foreign_port":"SIEGEN","customer":"SANDOZ B2B","customerCountry":"INDIA","quantity":"720.00","actualQuantity":"720","unit":"KGS","unitRateFc":"200","totalValueFC":"145479.7","currency":"USD","unitRateINR":"16890","date":"17-Jul-2024","totalValueINR":"12160800","totalValueInUsd":"145479.7","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"4553700","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SIEGEN","supplierAddress":"VIA COLLEONI, 15\/17 24040 CISERANO(BG) ItalySDNF Italy","customerAddress":"SANDOZ HOUSE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722277800,"product":"HYDROXYZINE PAMOATE F515\/2024 (BATCH NO. 101424038) (IGCRDSR. NO.2\/A\/155)","address":"SANDOZ HOUSE","city":"MUMBAI ,MAHARASHTRA","supplier":"COSMA S. P. A.","supplierCountry":"ITALY","foreign_port":"SIEGEN","customer":"SANDOZ B2B","customerCountry":"INDIA","quantity":"768.00","actualQuantity":"768","unit":"KGS","unitRateFc":"200","totalValueFC":"155362","currency":"USD","unitRateINR":"16910","date":"30-Jul-2024","totalValueINR":"12986880","totalValueInUsd":"155362","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"4787557","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"SIEGEN","supplierAddress":"VIA COLLEONI, 15\/17 24040 CISERANO(BG) ItalySDNF Italy","customerAddress":"SANDOZ HOUSE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731349800,"product":"HYDROXYZINE PAMOATE F547\/2024 (BATCH NO. 101424042) (IGCRDSR. NO.2\/A\/155)","address":"SANDOZ HOUSE","city":"MUMBAI ,MAHARASHTRA","supplier":"COSMA S. P. A.","supplierCountry":"ITALY","foreign_port":"GENOA","customer":"SANDOZ B2B","customerCountry":"INDIA","quantity":"760.00","actualQuantity":"760","unit":"KGS","unitRateFc":"200","totalValueFC":"153462.2","currency":"USD","unitRateINR":"17040","date":"12-Nov-2024","totalValueINR":"12950400","totalValueInUsd":"153462.2","indian_port":"JNPT","hs_no":"29335990","bill_no":"6637703","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"GENOA","supplierAddress":"VIA COLLEONI, 15\/17 24040 CISERANO (BG) Italy SDNF Italy","customerAddress":"SANDOZ HOUSE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731349800,"product":"HYDROXYZINE PAMOATE F563\/2024 (BATCH NO. 101424044) (IGCRDSR. NO.2\/A\/155)","address":"SANDOZ HOUSE","city":"MUMBAI ,MAHARASHTRA","supplier":"COSMA S. P. A.","supplierCountry":"ITALY","foreign_port":"GENOA","customer":"SANDOZ B2B","customerCountry":"INDIA","quantity":"771.00","actualQuantity":"771","unit":"KGS","unitRateFc":"200","totalValueFC":"155683.4","currency":"USD","unitRateINR":"17040","date":"12-Nov-2024","totalValueINR":"13137840","totalValueInUsd":"155683.4","indian_port":"JNPT","hs_no":"29335990","bill_no":"6637703","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"GENOA","supplierAddress":"VIA COLLEONI, 15\/17 24040 CISERANO (BG) Italy SDNF Italy","customerAddress":"SANDOZ HOUSE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731349800,"product":"HYDROXYZINE PAMOATE F578\/2024 (BATCH NO. 101424046) (IGCRDSR. NO.2\/A\/155)","address":"SANDOZ HOUSE","city":"MUMBAI ,MAHARASHTRA","supplier":"COSMA S. P. A.","supplierCountry":"ITALY","foreign_port":"GENOA","customer":"SANDOZ B2B","customerCountry":"INDIA","quantity":"720.00","actualQuantity":"720","unit":"KGS","unitRateFc":"200","totalValueFC":"145385.3","currency":"USD","unitRateINR":"17040","date":"12-Nov-2024","totalValueINR":"12268800","totalValueInUsd":"145385.3","indian_port":"JNPT","hs_no":"29335990","bill_no":"6637703","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"GENOA","supplierAddress":"VIA COLLEONI, 15\/17 24040 CISERANO (BG) Italy SDNF Italy","customerAddress":"SANDOZ HOUSE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731349800,"product":"HYDROXYZINE PAMOATE BATCH NO: 113824008","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"COSMA S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"839.00","actualQuantity":"839","unit":"KGS","unitRateFc":"173.5","totalValueFC":"146966.8","currency":"USD","unitRateINR":"14782.2","date":"12-Nov-2024","totalValueINR":"12402265.8","totalValueInUsd":"146966.8","indian_port":"Ahmedabad Air","hs_no":"29335990","bill_no":"6626358","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"SOCIETA CON SOCIO UNICO CAP. SOC. 954.600 I.V. COD. FISC PART IVA IT 00714610169 VIA COLLEON IT","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731349800,"product":"HYDROXYZINE PAMOATE BATCH NO: 113824009","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"COSMA S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"795.00","actualQuantity":"795","unit":"KGS","unitRateFc":"173.5","totalValueFC":"139259.4","currency":"USD","unitRateINR":"14782.2","date":"12-Nov-2024","totalValueINR":"11751849","totalValueInUsd":"139259.4","indian_port":"Ahmedabad Air","hs_no":"29335990","bill_no":"6626358","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"SOCIETA CON SOCIO UNICO CAP. SOC. 954.600 I.V. COD. FISC PART IVA IT 00714610169 VIA COLLEON IT","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731436200,"product":"HYDROXYZINE PAMOATE F651\/2024 (BATCH NO. 101424053) (IGCRDSR. NO.2\/A\/155)","address":"SANDOZ HOUSE","city":"MUMBAI ,MAHARASHTRA","supplier":"COSMA S. P. A.","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"SANDOZ B2B","customerCountry":"INDIA","quantity":"736.00","actualQuantity":"736","unit":"KGS","unitRateFc":"200","totalValueFC":"148616.1","currency":"USD","unitRateINR":"17040","date":"13-Nov-2024","totalValueINR":"12541440","totalValueInUsd":"148616.1","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"6648438","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"VIA COLLEONI, 15\/17 24040 CISERANO (BG) Italy SDNF Italy","customerAddress":"SANDOZ HOUSE"}]

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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DOSAGE - CAPSULE;ORAL - EQ 100MG HYDROCHLORID...DOSAGE - CAPSULE;ORAL - EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 11459

DOSAGE - CAPSULE;ORAL - EQ 25MG HYDROCHLORIDE

USFDA APPLICATION NUMBER - 11459

DOSAGE - CAPSULE;ORAL - EQ 50MG HYDROCHLORIDE

USFDA APPLICATION NUMBER - 11459

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click here to find a list of Hydroxyzine Pamoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Hydroxyzine Pamoate Suppliers

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

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

Hydroxyzine Pamoate USDMF

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

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

click here to find a list of Hydroxyzine Pamoate suppliers with USDMF on PharmaCompass.

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

Hydroxyzine Pamoate 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 Hydroxyzine Pamoate as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Hydroxyzine Pamoate suppliers with NDC on PharmaCompass.

Hydroxyzine Pamoate GMP

Hydroxyzine Pamoate 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 Hydroxyzine Pamoate 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 Hydroxyzine Pamoate GMP manufacturer or Hydroxyzine Pamoate GMP API supplier for your needs.

Hydroxyzine Pamoate CoA

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

Hydroxyzine Pamoate CoA mostly includes findings from lab analyses of a specific batch. For each Hydroxyzine Pamoate 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.

Hydroxyzine Pamoate may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydroxyzine Pamoate EP), Hydroxyzine Pamoate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydroxyzine Pamoate 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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ACTIVE PHARMA INGREDIENTS

10 API Suppliers

7 USDMF

1 JDMF

7 NDC API

5 Listed Suppliers

$ API Reference Price

FINISHED DOSAGE FORMULATIONS

41 FDF Dossiers

41 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 25MG HYDROCHLORIDE

CAPSULE;ORAL - EQ 50MG HYDROCHLORIDE

RELATED EXCIPIENT COMPANIES

6 DKSH

4 ACG Worldwide

1 Gangwal Chemicals

3 Lonza Capsugel

1 Qualicaps

2 Roquette

EXCIPIENTS BY APPLICATIONS

8 Empty Capsules

5 Coating Systems & Additives

4 Thickeners and Stabilizers

4 Fillers, Diluents & Binders

2 Coloring Agents

2 Film Formers & Plasticizers

1 Taste Masking

DIGITAL CONTENT

1 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

MARKET PLACE

3 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 USP

1 Others

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 188

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0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

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PATENTS & EXCLUSIVITIES

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CAPSULE;ORAL - EQ 100MG HYDROCHLORIDE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons