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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

Naltrexone Hydrochloride
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 Weight 377.9 g/mol
Molecular Formula C20H24ClNO4
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count5
Rotatable Bond Count2
Exact Mass377.1393859 g/mol
Monoisotopic Mass377.1393859 g/mol
Topological Polar Surface Area70 Ų
Heavy Atom Count26
Formal Charge0
Complexity621
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 6  
Drug NameNaltrexone hydrochloride
PubMed HealthNaltrexone
Drug ClassesEthanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
Drug LabelNaltrexone 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 IngredientNaltrexone hydrochloride
Dosage FormTablet
RouteOral
Strength25mg; 100mg; 50mg
Market StatusPrescription
CompanyAccord Hlthcare; Mallinckrodt; Sun Pharma Global; Elite Labs; Barr

2 of 6  
Drug NameRevia
PubMed HealthNaltrexone
Drug ClassesEthanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
Drug LabelREVIA (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 IngredientNaltrexone hydrochloride
Dosage FormTablet
RouteOral
Strength50mg
Market StatusPrescription
CompanyTeva Womens

3 of 6  
Drug NameVivitrol
Active IngredientNaltrexone
Dosage FormFor suspension, extended release
RouteIntramuscular
Strength380mg/vial
Market StatusPrescription
CompanyAlkermes

4 of 6  
Drug NameNaltrexone hydrochloride
PubMed HealthNaltrexone
Drug ClassesEthanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
Drug LabelNaltrexone 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 IngredientNaltrexone hydrochloride
Dosage FormTablet
RouteOral
Strength25mg; 100mg; 50mg
Market StatusPrescription
CompanyAccord Hlthcare; Mallinckrodt; Sun Pharma Global; Elite Labs; Barr

5 of 6  
Drug NameRevia
PubMed HealthNaltrexone
Drug ClassesEthanol Dependency, Opioid Dependency, Toxicology-Antidote Agent
Drug LabelREVIA (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 IngredientNaltrexone hydrochloride
Dosage FormTablet
RouteOral
Strength50mg
Market StatusPrescription
CompanyTeva Womens

6 of 6  
Drug NameVivitrol
Active IngredientNaltrexone
Dosage FormFor suspension, extended release
RouteIntramuscular
Strength380mg/vial
Market StatusPrescription
CompanyAlkermes

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 Reference Price

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(NALTREXONE HYDROCHLORIDE USP)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"MALLINCKRODT PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"CHICAGO O\\'HARE INT\\'L","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"45.00","actualQuantity":"45","unit":"KGS","unitRateFc":"4600","totalValueFC":"209670","currency":"USD","unitRateINR":"387857.6","date":"19-Dec-2023","totalValueINR":"17453590.02","totalValueInUsd":"209670","indian_port":"Ahmedabad Air","hs_no":"29391900","bill_no":"9308539","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO O\\'HARE INT\\'L","supplierAddress":"PERTH HOUSE, MILLENNIUM WAY DUNSTON, CHESTERFIELD DERBYSHIRE,S41 8ND United Kingdom, , United Kingdom United Kingdom","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708626600,"product":"NALTREXONE HYDROCHLORIDE API-EP-0-0-0","address":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL","city":"HYDERABAD, AP","supplier":"SANECA PHARMACEUTICALS","supplierCountry":"SLOVAKIA","foreign_port":"BRATISLAVA","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"20.50","actualQuantity":"20.5","unit":"KGS","unitRateFc":"3800","totalValueFC":"85106.8","currency":"EUR","unitRateINR":"344470","date":"23-Feb-2024","totalValueINR":"7061635","totalValueInUsd":"85106.8","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"2272137","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVAK REPUBLIC","selfForZScoreResived":"Pharma Grade","supplierPort":"BRATISLAVA","supplierAddress":"NITRIANSKA 100 920 27 HLOHOVECSLOVAK REPUBLICSDNF SK","customerAddress":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720117800,"product":"NALTREXONE HCL BATCH : EAR2002, PR. CODE 240965 MFG. 08.03.2024, EXP. DATE 08.03.2027 ( FOC )","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"FRANCOPIA","supplierCountry":"FRANCE","foreign_port":"PARIS - CHARLES DE G","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"0.96","actualQuantity":"0.96","unit":"KGS","unitRateFc":"4600","totalValueFC":"4461.4","currency":"USD","unitRateINR":"388470","date":"05-Jul-2024","totalValueINR":"372931.2","totalValueInUsd":"4461.4","indian_port":"Ahmedabad Air","hs_no":"29391900","bill_no":"4347335","productDescription":"API","marketType":"REGULATED MARKET","country":"FRANCE","selfForZScoreResived":"Pharma Grade","supplierPort":"PARIS - CHARLES DE G","supplierAddress":"15, rue Traversi?re 75012 PARIS FRANCE Paris, FRANCESDNF FRANCE","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724697000,"product":"NALTREXONE HYDROCHLORIDE USP. MFG. JUNE 2024 RETEST DATE MAY2028 LOT NO.2406000192, 2406000099,2406000201, 2406000160,2","address":"CORPORATE HOUSE, NR. SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"MALLINCKRODT PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"CHICAGO, IL","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"375.00","actualQuantity":"375","unit":"KGS","unitRateFc":"4600","totalValueFC":"1764609.4","currency":"USD","unitRateINR":"394701","date":"27-Aug-2024","totalValueINR":"148012870.3","totalValueInUsd":"1764609.4","indian_port":"Ahmedabad Air","hs_no":"29391900","bill_no":"5265696","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"CHICAGO, IL","supplierAddress":"PERTH HOUSE, MILLENNIUM WAY DUNSTON, CHESTERFIELD DERBYSHIRE.S41 8ND DERBYSHIRE, UNITED STATES UNITED STATES","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"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":"(147906) NALTREXONE HYDROCHLORIDE USP","address":"2ND FLOOR, CHINUBHAI CENTRE,,OFF.","city":"AHMEDABAD,GUJARAT","supplier":"MALLINCKRODT PHARMACEUTICALS","supplierCountry":"UNITED STATES","foreign_port":"N\/A","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"4600","totalValueFC":"940953.7","currency":"USD","unitRateINR":"397026.9","date":"30-Nov-2024","totalValueINR":"79405372.5","totalValueInUsd":"940953.7","indian_port":"Ahmedabad Air","hs_no":"29391900","bill_no":"6970608","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"PERTH HOUSE MILLENNIUM WAY DUNSTON United Kingdom","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,,OFF."},{"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."}]
11-Jan-2021
28-Feb-2025
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DRUG PRODUCT COMPOSITIONS

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

USFDA APPLICATION NUMBER - 200063

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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

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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

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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

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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

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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

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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

Looking for 16676-29-2 / Naltrexone Hydrochloride API manufacturers, exporters & distributors?

Naltrexone Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Naltrexone Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Naltrexone Hydrochloride manufacturer or Naltrexone Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Naltrexone Hydrochloride manufacturer or Naltrexone Hydrochloride supplier.

PharmaCompass also assists you with knowing the Naltrexone Hydrochloride API Price utilized in the formulation of products. Naltrexone Hydrochloride API Price is not always fixed or binding as the Naltrexone Hydrochloride Price is obtained through a variety of data sources. The Naltrexone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Naltrexone Hydrochloride

Synonyms

Naltrexone hcl, 16676-29-2, Trexan, Depade, Antaxone, Revia

Cas Number

16676-29-2

Unique Ingredient Identifier (UNII)

Z6375YW9SF

About Naltrexone Hydrochloride

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.

Vivitrol Manufacturers

A Vivitrol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vivitrol, including repackagers and relabelers. The FDA regulates Vivitrol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vivitrol 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 Vivitrol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Vivitrol Suppliers

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

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

Vivitrol USDMF

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

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

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

Vivitrol KDMF

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

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

After submitting a Vivitrol 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 Vivitrol API can apply through the Korea Drug Master File (KDMF).

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

Vivitrol CEP

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

A Vivitrol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vivitrol 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 Vivitrol suppliers with CEP (COS) on PharmaCompass.

Vivitrol WC

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

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

Vivitrol 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 Vivitrol as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Vivitrol GMP

Vivitrol 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 Vivitrol 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 Vivitrol GMP manufacturer or Vivitrol GMP API supplier for your needs.

Vivitrol CoA

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

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

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