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Naltrexone Hydrochloride

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

25 API Suppliers, 9 USDMF, 8 CEP/COS, 2 EU WC, 7 KDMF, 46 NDC API, 18 Listed Suppliers, $ API Reference Price

25 API Suppliers
9 USDMF
8 CEP/COS
2 EU WC
7 KDMF
46 NDC API
18 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

14 Drugs in Development

14 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

48 FDF Dossiers, 23 FDA Orange Book, 14 Europe, 4 Canada, 2 South Africa, 5 Listed Dossiers

48 FDF Dossiers
23 FDA Orange Book
14 Europe
4 Canada
2 South Africa
5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG, CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

drugProductComposition
TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG
CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

3 Evonik, 1 SPI Pharma, 2 Seqens, 8 DKSH, 4 Faran Shimi Pharmaceutical, 9 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 1 Clariant, 18 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 10 Gangwal Chemicals, 9 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 35 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 10 Roquette, 12 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Valens Pharmachem, 3 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

63 Coating Systems & Additives, 55 Fillers, Diluents & Binders, 42 Controlled & Modified Release, 25 Thickeners and Stabilizers, 24 Direct Compression, 19 Granulation, 19 Solubilizers, 15 Lubricants & Glidants, 15 Disintegrants & Superdisintegrants, 13 Film Formers & Plasticizers, 13 Co-Processed Excipients, 12 Parenteral, 12 Topical, 11 Taste Masking, 9 Empty Capsules, 7 Emulsifying Agents, 5 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 3 Chewable & Orodispersible Aids

DIGITAL CONTENT

47 NEWS #PharmaBuzz

media
47 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 17 Finished Drug Prices

globalSalesInformation
2 US Medicaid Prescriptions
17 Finished Drug Prices

MARKET PLACE

16 APIs, 3 FDF Dossiers

marketPlace
16 APIs
3 FDF Dossiers

PATENTS & EXCLUSIVITIES

88 US Patents

patents
88 US Patents

REF. STANDARDS & IMPURITIES

2 EDQM , 7 Others

otherSolutions
2 EDQM
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)

$ 6,831

MARKET PLACE

API

FDF

3INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

14DRUGS 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)

71,210,546

Annual Reports (USD Million)

Finished Drug Prices

230 RELATED EXCIPIENT COMPANIES

380EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Naltrexone hcl, 16676-29-2, Trexan, Depade, Antaxone, Revia

Molecular Formula

C₂₀H₂₄ClNO₄

Molecular Weight

377.9 g/mol

InChI Key

RHBRMCOKKKZVRY-ITLPAZOVSA-N

FDA UNII

Z6375YW9SF

Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.

1 2D Structure

Naltrexone Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

2.1.2 InChI

InChI=1S/C20H23NO4.ClH/c22-13-4-3-12-9-15-20(24)6-5-14(23)18-19(20,16(12)17(13)25-18)7-8-21(15)10-11-1-2-11;/h3-4,11,15,18,22,24H,1-2,5-10H2;1H/t15-,18+,19+,20-;/m1./s1

2.1.3 InChI Key

RHBRMCOKKKZVRY-ITLPAZOVSA-N

2.1.4 Canonical SMILES

C1CC1CN2CCC34C5C(=O)CCC3(C2CC6=C4C(=C(C=C6)O)O5)O.Cl

2.1.5 Isomeric SMILES

C1CC1CN2CC[C@]34[C@@H]5C(=O)CC[C@]3([C@H]2CC6=C4C(=C(C=C6)O)O5)O.Cl

2.2 Other Identifiers

2.2.1 UNII

Z6375YW9SF

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Antaxone

2. Celupan

3. En 1639a

4. En-1639a

5. En1639a

6. Nalorex

7. Naltrexone

8. Nemexin

9. Revia

10. Trexan

2.3.2 Depositor-Supplied Synonyms

1. Naltrexone Hcl

2. 16676-29-2

3. Trexan

4. Depade

5. Antaxone

6. Revia

7. Naltrexone (hydrochloride)

8. En-1639a

9. Nih 8503

10. Celupan

11. Nemexin

12. N-cyclopropylmethyl-noroxymorphone Hydrochloride

13. Mls000069607

14. Naltrexone Hydrochloride [usp]

15. Z6375yw9sf

16. Vivitrex

17. 17-(cyclopropylmethyl)-4,5-alpha-epoxy-3,14-dihydroxy-morphinan-6-one Hydrochloride

18. Nalorex

19. Smr000058767

20. En-1639a (as Hydrochloride)

21. En 1639a

22. (4r,4as,7ar,12bs)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

23. Naltrexone Hydrochloride (usp)

24. (4r,4as,7ar,12bs)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,3,4,4a,5,6-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7(7ah)-one Hydrochloride

25. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, Hydrochloride (1:1), (5alpha)-

26. Ccris 1168

27. Einecs 240-723-0

28. Unii-z6375yw9sf

29. Naltrel

30. Naltrexone.hcl

31. Naltrexone Depot

32. Prestwick_348

33. Mfcd00069324

34. (5alpha)-17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

35. Revia (tn)

36. Xr-ntx

37. (4r,4as,7ar,12bs)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride

38. Opera_id_1828

39. Naltrexone Monohydrochloride

40. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-alpha-epoxy-3,14-dihydroxy-, Hydrochloride

41. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, Hydrochloride, (5-alpha)-

42. Schembl37713

43. Mls001076516

44. Mls002153483

45. Mls002695940

46. Cyto-205

47. Chembl1201149

48. Dtxsid50937236

49. Pti-901

50. Chebi:134687

51. Bcp08343

52. Naltrexone Hydrochloride [mi]

53. S2103

54. Vp-004

55. Akos015994597

56. Ccg-268383

57. Cs-0763

58. Hs-0003

59. Nc00693

60. 17-cyclopropylmethyl)-4,5alpha-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

61. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-alpha-oxy-3,14-dihydoxy-, Hydrochloride

62. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, Hydrochloride, (5alpha)-

63. Naltrexone Hydrochloride [mart.]

64. Naltrexone Hydrochloride [vandf]

65. Naltrexone Hydrochloride [who-dd]

66. Bn164635

67. Hy-76710

68. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, Hydrochloride, (5.alpha.)-

69. N1176

70. Naltrexone Hydrochloride [green Book]

71. Sw196619-3

72. Naltrexone Hydrochloride [orange Book]

73. D02095

74. Embeda Component Naltrexone Hydrochloride

75. H10489

76. Naltrexone Hydrochloride [ep Monograph]

77. Naltrexone Hydrochloride [usp Monograph]

78. Troxyca Component Naltrexone Hydrochloride

79. 676n292

80. Contrave Component Naltrexone Hydrochloride

81. Naltrexone Hydrochloride Component Of Embeda

82. Naltrexone Hydrochloride Component Of Troxyca

83. Naltrexone Hydrochloride Component Of Contrave

84. Q27096434

85. Z1558290144

86. Naltrexone Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)

87. Naltrexone Hydrochloride, European Pharmacopoeia (ep) Reference Standard

88. (5a)-17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-morphinan-6-one Hydrochloride

89. 17-(cyclopropylmethyl)-3,14-dihydroxy-4,5alpha-epoxymorphinan-6-one Hydrochloride

90. 17-cyclopropylmethyl)-4,5.alpha.-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

91. (1s,5r,13r,17s)-4-(cyclopropylmethyl)-10,17-dihydroxy-12-oxa-4-azapentacyclo[9.6.1.0^{1,13}.0^{5,17}.0^{7,18}]octadeca-7(18),8,10-trien-14-one Hydrochloride

92. (4r,4as,7ar,12bs)-3-(cyclopropylmethyl)-4a,9-dihydroxy-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydron;chloride

93. (5alpha,17r)-17-(cyclopropylmethyl)-3,14-dihydroxy-6-oxo-4,5-epoxymorphinan-17-ium Chloride

94. Morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-, (5.alpha.)-, Hydrochloride (1:1)

2.4 Create Date

2005-08-08

3 Chemical and Physical Properties

Molecular Formula	C₂₀H₂₄ClNO₄
Molecular Weight	377.9 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	2
Exact Mass	377.1393859 g/mol
Monoisotopic Mass	377.1393859 g/mol
Topological Polar Surface Area	70 Å²
Heavy Atom Count	26
Formal Charge	0
Complexity	621
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
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 6
Drug Name	Naltrexone hydrochloride
PubMed Health	Naltrexone
Drug Classes	Ethanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
Drug Label	Naltrexone hydrochloride, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethy...
Active Ingredient	Naltrexone hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	25mg; 100mg; 50mg
Market Status	Prescription
Company	Accord Hlthcare; Mallinckrodt; Sun Pharma Global; Elite Labs; Barr

2 of 6
Drug Name	Revia
PubMed Health	Naltrexone
Drug Classes	Ethanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
Drug Label	REVIA (naltrexone hydrochloride tablets USP), an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced...
Active Ingredient	Naltrexone hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	50mg
Market Status	Prescription
Company	Teva Womens

3 of 6
Drug Name	Vivitrol
Active Ingredient	Naltrexone
Dosage Form	For suspension, extended release
Route	Intramuscular
Strength	380mg/vial
Market Status	Prescription
Company	Alkermes

4 of 6
Drug Name	Naltrexone hydrochloride
PubMed Health	Naltrexone
Drug Classes	Ethanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
Drug Label	Naltrexone hydrochloride, an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced by a cyclopropylmethy...
Active Ingredient	Naltrexone hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	25mg; 100mg; 50mg
Market Status	Prescription
Company	Accord Hlthcare; Mallinckrodt; Sun Pharma Global; Elite Labs; Barr

5 of 6
Drug Name	Revia
PubMed Health	Naltrexone
Drug Classes	Ethanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
Drug Label	REVIA (naltrexone hydrochloride tablets USP), an opioid antagonist, is a synthetic congener of oxymorphone with no opioid agonist properties. Naltrexone differs in structure from oxymorphone in that the methyl group on the nitrogen atom is replaced...
Active Ingredient	Naltrexone hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	50mg
Market Status	Prescription
Company	Teva Womens

6 of 6
Drug Name	Vivitrol
Active Ingredient	Naltrexone
Dosage Form	For suspension, extended release
Route	Intramuscular
Strength	380mg/vial
Market Status	Prescription
Company	Alkermes

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Alcohol Deterrents

Substances interfering with the metabolism of ethyl alcohol, causing unpleasant side effects thought to discourage the drinking of alcoholic beverages. Alcohol deterrents are used in the treatment of alcoholism. (See all compounds classified as Alcohol Deterrents.)

Narcotic Antagonists

Agents inhibiting the effect of narcotics on the central nervous system. (See all compounds classified as Narcotic Antagonists.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Opioid Antagonists [MoA]; Opioid Antagonist [EPC]

API SUPPLIERS

01

LGM Pharma

U.S.A

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

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02

Faran Shimi Pharmaceutical

Iran

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

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Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

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03

Temad Co

Iran

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

MAGHREB PHARMA

Attending

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04

EUROAPI

France

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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France

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05

Veranova

U.S.A

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Veranova: A CDMO that manages complexity with confidence.

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06

Aspen API

Netherlands

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Aspen API. More than just an API.

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Jai Radhe Sales

India

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Rusan Pharma

India

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Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.

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Deccan Nutraceuticals Pvt. Ltd

India

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Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.

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HRV Global Life Sciences

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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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USDMF

01

Francopia A Euroapi Co

France

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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France

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NALTREXONE HYDROCHLORIDE

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-17

Pay. Date : 2013-03-11

DMF Number : 20623

Submission : 2007-06-20

Status : Active

Type : II

02

Macfarlan Smith Ltd

U.S.A

BIO Partnering at JPM

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Veranova: A CDMO that manages complexity with confidence.

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U.S.A

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NALTREXONE HYDROCHLORIDE

GDUFA

DMF Review : Complete

Rev. Date : 2012-12-27

Pay. Date : 2012-11-30

DMF Number : 21590

Submission : 2008-04-29

Status : Active

Type : II

03

Aspen Oss Bv

Netherlands

Tides Asia

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Aspen API. More than just an API.

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Netherlands

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NALTREXONE HYDROCHLORIDE

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DMF Review : Complete

Rev. Date : 2015-06-16

Pay. Date : 2012-12-20

DMF Number : 15102

Submission : 2000-10-18

Status : Active

Type : II

04

Noramco Llc

U.S.A

BIO Partnering at JPM

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Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

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U.S.A

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NALTREXONE HYDROCHLORIDE DRUG SUBSTANC...

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DMF Review : Complete

Rev. Date : 2014-01-14

Pay. Date : 2013-12-20

DMF Number : 23325

Submission : 2009-12-01

Status : Active

Type : II

05

Mallinckrodt Inc The Pharmaceuticals...

Ireland

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06

Specgx Llc

Ireland

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07

Siegfried Ltd

Switzerland

BIO Partnering at JPM

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08

Sun Pharmaceutical Industries Ltd

India

BIO Partnering at JPM

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09

Sun Pharmaceutical Industries Ltd

India

BIO Partnering at JPM

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API Reference Price

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SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"NALTREXONE HYDROCHLORIDE API-0-0-0","address":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL","city":"HYDERABAD, AP","supplier":"WOOD & COMPANY FINANCIAL SERVICES","supplierCountry":"SLOVAKIA","foreign_port":"BRATISLAVA","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"3950","totalValueFC":"66354.8","currency":"EUR","unitRateINR":"370707.5","date":"05-Sep-2024","totalValueINR":"5560612.5","totalValueInUsd":"66354.8","indian_port":"Hyderabad Air","hs_no":"29391900","bill_no":"5442481","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVAKIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BRATISLAVA","supplierAddress":"NITRIANSKA 100 92027 HIOHOVEC SDNF SK","customerAddress":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730917800,"product":"NALTREXONE HYDROCHLORIDE USP (TEST LIC. NO. SW\/ND\/CT-17\/2024\/000004815) FOR R & D PURPOSE NOT FOR SALE","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR","city":"AHMEDABAD\/GUJRAT","supplier":"SIEGFRIED AG","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"5000","totalValueFC":"5507.3","currency":"EUR","unitRateINR":"464750","date":"07-Nov-2024","totalValueINR":"464750","totalValueInUsd":"5507.3","indian_port":"Bombay Air","hs_no":"29391900","bill_no":"6554300","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"UNTERE BRUHLSTRASSE 4 4800 ZOFINGEN Zofingen, , Switzerland SDNF Switzerland","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732732200,"product":"NALTREXONE HYDROCHLORIDE API-EP-0-0-33 BATCH NO. 3160924 MFG. 17.09.2024 EXP. 31.08.2027 MAT. NO. 12005080","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"WOOD & COMPANY FINANCIAL SERVICES","supplierCountry":"SLOVAKIA","foreign_port":"BRATISLAVA","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"3900","totalValueFC":"209816.1","currency":"EUR","unitRateINR":"354120","date":"28-Nov-2024","totalValueINR":"17706000","totalValueInUsd":"209816.1","indian_port":"Ahmedabad Air","hs_no":"29391900","bill_no":"6925659","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVAKIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BRATISLAVA","supplierAddress":"Nitrianska 100 92027 Hlohovec SLOV AKIA Hlohovec, , SLOVAK REPUBLIC SDNF SLOVAK REPUBLIC","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732905000,"product":"NALTREXONE HYDROCHLORIDE API-USP-0-0-0.","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"WOOD & COMPANY FINANCIAL SERVICES","supplierCountry":"SLOVAKIA","foreign_port":"N\/A","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"4050","totalValueFC":"2178.9","currency":"EUR","unitRateINR":"367740","date":"30-Nov-2024","totalValueINR":"183870","totalValueInUsd":"2178.9","indian_port":"Bombay Air","hs_no":"29391900","bill_no":"6980468","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVAKIA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"NITRIANSKA 100 920 27 HIOHOVEC SLOV AK REPUBLIC SDNF","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1735497000,"product":"NALTREXONE HCL. PR. CODE : 240965. BATCH:EAR2004 MFG. 21.05.2024 RETEST 21.05.2027, BATCH:EARS001 MFG. 20.11.2024 EXP. 2NALTREXONE HCL. PR. CODE : 240965. BATCH:EAR2004 MFG. 21.05.","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"FRANCOPIA","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"133.04","actualQuantity":"133.04","unit":"KGS","unitRateFc":"5800","totalValueFC":"780540.9","currency":"USD","unitRateINR":"498510","date":"30-Dec-2024","totalValueINR":"66321770.4","totalValueInUsd":"780540.9","indian_port":"Ahmedabad Air","hs_no":"29391900","bill_no":"7518792","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"15, rue Traversi?re 75012 PARIS FRA NCE Paris, , FRANCE SDNF FRANCE","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"}]

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 - TABLET, EXTENDED RELEASE;ORAL - 90MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG

USFDA APPLICATION NUMBER - 200063

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22321

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22321

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22321

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22321

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22321

DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 80M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 22321

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ABOUT THIS PAGE

Naltrexone Hydrochloride Manufacturers

A Naltrexone Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naltrexone Hydrochloride, including repackagers and relabelers. The FDA regulates Naltrexone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naltrexone Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

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

Naltrexone Hydrochloride Suppliers

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

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

Naltrexone Hydrochloride USDMF

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

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

click here to find a list of Naltrexone Hydrochloride suppliers with USDMF on PharmaCompass.

Naltrexone Hydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Naltrexone Hydrochloride Drug Master File in Korea (Naltrexone Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naltrexone Hydrochloride. The MFDS reviews the Naltrexone Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Naltrexone Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Naltrexone Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Naltrexone Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Naltrexone Hydrochloride suppliers with KDMF on PharmaCompass.

Naltrexone Hydrochloride CEP

A Naltrexone Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Naltrexone Hydrochloride Certificate of Suitability (COS). The purpose of a Naltrexone Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Naltrexone Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Naltrexone Hydrochloride to their clients by showing that a Naltrexone Hydrochloride CEP has been issued for it. The manufacturer submits a Naltrexone Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Naltrexone Hydrochloride CEP holder for the record. Additionally, the data presented in the Naltrexone Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Naltrexone Hydrochloride DMF.

A Naltrexone Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Naltrexone Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Naltrexone Hydrochloride suppliers with CEP (COS) on PharmaCompass.

Naltrexone Hydrochloride WC

A Naltrexone Hydrochloride written confirmation (Naltrexone Hydrochloride WC) is an official document issued by a regulatory agency to a Naltrexone Hydrochloride manufacturer, verifying that the manufacturing facility of a Naltrexone Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naltrexone Hydrochloride APIs or Naltrexone Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Naltrexone Hydrochloride WC (written confirmation) as part of the regulatory process.

click here to find a list of Naltrexone Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.

Naltrexone Hydrochloride 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 Naltrexone Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Naltrexone Hydrochloride suppliers with NDC on PharmaCompass.

Naltrexone Hydrochloride GMP

Naltrexone Hydrochloride 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 Naltrexone Hydrochloride 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 Naltrexone Hydrochloride GMP manufacturer or Naltrexone Hydrochloride GMP API supplier for your needs.

Naltrexone Hydrochloride CoA

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

Naltrexone Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Naltrexone Hydrochloride 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.

Naltrexone Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Naltrexone Hydrochloride EP), Naltrexone Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naltrexone Hydrochloride 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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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

25 API Suppliers

9 USDMF

8 CEP/COS

2 EU WC

7 KDMF

46 NDC API

18 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

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INTERMEDIATES

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FINISHED DOSAGE FORMULATIONS

48 FDF Dossiers

23 FDA Orange Book

14 Europe

4 Canada

2 South Africa

5 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG

CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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EXCIPIENTS BY APPLICATIONS

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CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons