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Chemistry

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Also known as: Naloxone hcl, 357-08-4, Narcan, Narcanti, Naloxone (hydrochloride), Evzio
Molecular Formula
C19H22ClNO4
Molecular Weight
363.8  g/mol
InChI Key
RGPDIGOSVORSAK-STHHAXOLSA-N
FDA UNII
F850569PQR

Naloxone Hydrochloride
A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.
1 2D Structure

Naloxone Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(4R,4aS,7aR,12bS)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride
2.1.2 InChI
InChI=1S/C19H21NO4.ClH/c1-2-8-20-9-7-18-15-11-3-4-12(21)16(15)24-17(18)13(22)5-6-19(18,23)14(20)10-11;/h2-4,14,17,21,23H,1,5-10H2;1H/t14-,17+,18+,19-;/m1./s1
2.1.3 InChI Key
RGPDIGOSVORSAK-STHHAXOLSA-N
2.1.4 Canonical SMILES
C=CCN1CCC23C4C(=O)CCC2(C1CC5=C3C(=C(C=C5)O)O4)O.Cl
2.1.5 Isomeric SMILES
C=CCN1CC[C@]23[C@@H]4C(=O)CC[C@]2([C@H]1CC5=C3C(=C(C=C5)O)O4)O.Cl
2.2 Other Identifiers
2.2.1 UNII
F850569PQR
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Abello, Naloxone

2. Curamed, Naloxon

3. Dihydride, Naloxone Hydrochloride

4. Hydrobromide, Naloxone

5. Hydrochloride Dihydride, Naloxone

6. Hydrochloride, Naloxone

7. Mrz 2593

8. Mrz 2593 Br

9. Mrz 2593-br

10. Mrz 2593br

11. Mrz-2593

12. Mrz2593

13. Nalone

14. Naloxon Curamed

15. Naloxon Ratiopharm

16. Naloxon-ratiopharm

17. Naloxone

18. Naloxone Abello

19. Naloxone Hydrobromide

20. Naloxone Hydrochloride Dihydride

21. Naloxone Hydrochloride, (5 Beta,9 Alpha,13 Alpha,14 Alpha)-isomer

22. Naloxone, (5 Beta,9 Alpha,13 Alpha,14 Alpha)-isomer

23. Narcan

24. Narcanti

2.3.2 Depositor-Supplied Synonyms

1. Naloxone Hcl

2. 357-08-4

3. Narcan

4. Narcanti

5. Naloxone (hydrochloride)

6. Evzio

7. Nih 7890

8. En-15304

9. Anhydrous Naloxone Hydrochloride

10. Chebi:31892

11. F850569pqr

12. Nsc-757109

13. (-)-n-allyl-14-hydroxynordihydromorphinone Hydrochloride

14. 357-08-4 (hcl)

15. 17-allyl-4,5alpha-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

16. (5alpha)-17-allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

17. (4r,4as,7ar,12bs)-3-allyl-4a,9-dihydroxy-2,3,4,4a,5,6-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7(7ah)-one Hydrochloride

18. Nalonee

19. Mls000069540

20. Naloxonehydrochloride

21. Smr000058766

22. Unii-f850569pqr

23. Prestwick_879

24. Einecs 206-611-0

25. Mfcd00069322

26. Narcan (tn)

27. Kloxxado

28. Evzio (tn)

29. Nafoxone Hydrochloride

30. Nal-oxon Hydrochloride

31. Naloxone Hydrochloride [usan:usp:jan]

32. En 15304

33. Chembl1718

34. C19h21no4.hcl

35. Schembl41390

36. L-n-allyl-14-hydroxynordihydromorphinone Hydrochloride

37. Naloxone Hydrochloride Anhydrous

38. Dtxsid70957097

39. Hms1568g04

40. Naloxone Hydrochloride [mi]

41. Act02626

42. Naloxone Hydrochloride (jp17/usp)

43. Naloxone Hydrochloride [jan]

44. (5a)-17-allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

45. 17-allyl-4,5-alpha-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

46. Naloxone Hydrochloride [usan]

47. Normorphinone, N-allyl-7,8-dihydro-14-hydroxy-, Hydrochloride, (-)-

48. S3066

49. Naloxone Hydrochloride [vandf]

50. Akos024418753

51. Morphinan-6-one, 17-allyl-4,5-alpha-epoxy-3,14-dihydroxy-, Hydrochloride

52. Naloxone Hydrochloride [mart.]

53. Ccg-220111

54. Cs-1335

55. Ks-5379

56. Naloxone Hydrochloride [who-dd]

57. Nc00587

58. Nsc 757109

59. Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, Hydrochloride, (5.alpha.)-

60. Hy-17417

61. Naloxone Hydrochloride [green Book]

62. Naloxone Hydrochloride [orange Book]

63. Sw197001-3

64. Naloxone Hydrochloride [usp Monograph]

65. D01340

66. Suboxone Component Naloxone Hydrochloride

67. Targiniq Component Naloxone Hydrochloride

68. Naloxone Hydrochloride Anhydrous [who-ip]

69. Talwin Nx Component Naloxone Hydrochloride

70. 357n084

71. Naloxone Hydrochloride Component Of Suboxone

72. Naloxone Hydrochloride Component Of Targiniq

73. Sr-01000597918

74. Sr-01000737374

75. Naloxone Hydrochloride Component Of Talwin Nx

76. Sr-01000597918-1

77. Sr-01000737374-3

78. W-106655

79. Q27114711

80. Naloxoni Hydrochloridum Anhydrous [who-ip Latin]

81. (5alpha)-17-allyl-3,14-dihydroxy-4,5-epoxymorphinan-6-one Hydrochloride

82. 17-allyl-3,14-dihydroxy-4,5alpha-epoxymorphinan-6-one Hydrochloride

83. (17r)-17-allyl-3,14-dihydroxy-6-oxo-4,5alpha-epoxymorphinan-17-ium Chloride

84. (5?)-4,5-epoxy-3,14-dihydro-17-(2-propenyl)morphinan-6-one Hydrochloride

85. (5a)-4,5-epoxy-3,14-dihydroxy-17-(2-propen-1-yl)-morphinan-6-one Hydrochloride

86. (5alpha)-4,5-epoxy-3,14-dihydroxy-17-(2-propen-1-yl)morphinan-6-one Hydrochloride (1:1)

87. (5alpha,17r)-17-allyl-3,14-dihydroxy-6-oxo-4,5-epoxymorphinan-17-ium Chloride

88. 17-allyl-4,5.alpha.-epoxy-3,14-dihydroxymorphinan-6-one Hydrochloride

89. Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-(2-propenyl)-, Hydrochloride, (5alpha)-

90. (4r,4as,12bs)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

91. (4r,4as,7ar,12bs)-4a,9-dihydroxy-3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;hydrochloride

92. (5alpha)-4,5-epoxy-3,14-dihydro-17-(2-pr Openyl)morphinan-6-one Hydrochloride

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 363.8 g/mol
Molecular Formula C19H22ClNO4
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count5
Rotatable Bond Count2
Exact Mass363.1237359 g/mol
Monoisotopic Mass363.1237359 g/mol
Topological Polar Surface Area70 Ų
Heavy Atom Count25
Formal Charge0
Complexity594
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 4  
Drug NameEvzio
PubMed HealthNaloxone (Injection)
Drug ClassesToxicology-Antidote Agent
Drug LabelEVZIO (naloxone hydrochloride injection, USP) is a pre-filled, single-use auto-injector. EVZIO is not made with natural rubber latex. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one h...
Active IngredientNaloxone hydrochloride
Dosage FormSolution
RouteIntramuscular, subcutaneous
Strength0.4mg/0.4ml
Market StatusPrescription
CompanyKaleo

2 of 4  
Drug NameNaloxone hydrochloride
Drug LabelAmpul, Fliptop Vial, Opioid AntagonistProtect from light.RxNaloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sod...
Active IngredientNaloxone hydrochloride
Dosage FormInjectable
RouteInjection
Strength1mg/ml; 0.4mg/ml
Market StatusPrescription
CompanyHospira; Intl Medication; Mylan Institutional

3 of 4  
Drug NameEvzio
PubMed HealthNaloxone (Injection)
Drug ClassesToxicology-Antidote Agent
Drug LabelEVZIO (naloxone hydrochloride injection, USP) is a pre-filled, single-use auto-injector. EVZIO is not made with natural rubber latex. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5-epoxy-3,14-dihydroxymorphinan-6-one h...
Active IngredientNaloxone hydrochloride
Dosage FormSolution
RouteIntramuscular, subcutaneous
Strength0.4mg/0.4ml
Market StatusPrescription
CompanyKaleo

4 of 4  
Drug NameNaloxone hydrochloride
Drug LabelAmpul, Fliptop Vial, Opioid AntagonistProtect from light.RxNaloxone Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of naloxone hydrochloride in water for injection. Each milliliter (mL) contains 0.4 mg naloxone hydrochloride and sod...
Active IngredientNaloxone hydrochloride
Dosage FormInjectable
RouteInjection
Strength1mg/ml; 0.4mg/ml
Market StatusPrescription
CompanyHospira; Intl Medication; Mylan Institutional

4.2 Drug Indication

Treatment of opioid-induced constipation


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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]

Listed Suppliers

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01

Veranova

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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Naloxone Hydrochloride

About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...

Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle. Macfarlan Smith Limited is trading as Veranova in the United Kingdom.
Veranova

02

  • fda
  • EDQM
  • WHO-GMP

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

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Naloxone

About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...

Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs) and finished dosage forms. For the past three years, the company focused on extracting alkaloid opiates, controlled substances, and narcotics. The APIs are widely used by major pharmaceutical companies nationwide and exported to the Middle East. All production adheres to local GMP standards in an SOP-driven environment with modern systems and utilities, ensuring the highest quality and safety.
Faran Shimi Pharmaceutical

03

Temad Co

Iran
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothTemad- We think of world-class quality.

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Naloxone Hydrochloride

About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...

Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Middle East. Apart from complying with Iranian GMP regulations, Temad has acquired the national & international standards of API manufacturing such as ISO 9001/14001/17025/45001 and OHSAS 18001. It currently manufactures more than 115 pharmaceutical products, including narcotics and non-narcotics, in accordance with GMP and WHO standards and regulations. Temad exports its products to 45 countries worldwide.
Temad

04

EUROAPI

France
  • fda
  • EDQM
  • WHO-GMP

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

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Naloxone Hydrochloride

About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...

EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our CDMO activities. Taking action for health by enabling access to essential therapies inspires our 3,650 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries.
EUROAPI Compnay Banner

05

LGM Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Naloxone Hydrochloride

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
LGM Pharma CB

06

Rusan Pharma

India
  • fda
  • EDQM
  • WHO-GMP

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

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Naloxone Hydrochloride

About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...

Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formulations, in the area of controlled substances. Our facilities are GMP-approved by Health Canada, EU, TGA, ANVISA, PIC/S, WHO, Russia & SAHPRA. We have CEP approval for various APIs such as Buprenorphine, Fentanyl, Naltrexone, Methadone, Bisoprolol & we also manufacture Naloxone, Nalbuphine, Nalmefene, Apomorphine, Efflornithine & Sodium Oxybate. We also develop & manufacture various transdermal patches & long-acting formulations such as depot injections & Implants.
Rusan Pharma

07

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  • EDQM
  • WHO-GMP

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

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Naloxone Hydrochloride

About the Company : Deccan Nutraceuticals Pvt. Ltd. (DNPL) is a group company of Alkaloids Corporation (India), was founded in 2001 and operates from a 22,000 sq. m. facility in Pune (India). Their co...

Deccan Nutraceuticals Pvt. Ltd. (DNPL) is a group company of Alkaloids Corporation (India), was founded in 2001 and operates from a 22,000 sq. m. facility in Pune (India). Their commitment to quality and adherence to Current Good Manufacturing Practices (CGMP) are integral to their operations. The company has been successfully audited by USFDA (5 times) and EDQM (2 times). The company manufactures high quality phytochemicals, semi-synthetic and synthetic APIs. DNPL stands as a responsible pharmaceutical manufacturer, devoted to delivering premium products across all the regions we serve.
Deccan Nutraceuticals

08

Noramco

U.S.A
  • fda
  • EDQM
  • WHO-GMP

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

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Naloxone Hydrochloride

About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...

Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and manufacturing, Noramco offers services like supply-chain integration for high-purity controlled substances, efficient routes to APIs, analytical data, stability studies, regulatory help, formulation-friendly particle size grades, extended technical packages, DEA-compliant security and production capacity from kilos to multi-ton supply. Noramco also offers world-class supply security for controlled substances, from Schedule I to Schedule III.
Noramco

09

PEGS Boston Summit
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Naloxone Hydrochloride

About the Company : Nhwa is specialized in manufacturing APIs and dosages in the field of Central Nervous System. With 40 years of experience and excellent reputation, Nhwa has become the leader of ma...

Nhwa is specialized in manufacturing APIs and dosages in the field of Central Nervous System. With 40 years of experience and excellent reputation, Nhwa has become the leader of manufacturing CNS drugs in China. The 520,000 m2 production base consists of five GMP workshops, R&D center and testing Lab
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Naloxone Hydrochloride

About the Company : Micro Orgo Chem is a pharmaceutical establishment, manufacturing niche Active Pharmaceutical Ingredients (API). Founded in 1992, we have a mission of providing high quality drugs t...

Micro Orgo Chem is a pharmaceutical establishment, manufacturing niche Active Pharmaceutical Ingredients (API). Founded in 1992, we have a mission of providing high quality drugs to the market. Over these years, we have expanded our product portfolio to hormones, narcotics analgesics, steroids and more. We aspire to use our experience of over two decades to continue to provide Micro Orgo Chem’s finest drugs to those in need.
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API Reference Price

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REDDY\\'S LABORATORIES","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"8000","totalValueFC":"8132.1","currency":"USD","unitRateINR":"707200","date":"13-Feb-2025","totalValueINR":"707200","totalValueInUsd":"8132.1","indian_port":"Vizag-EPZ\/SEZ","hs_no":"29391900","bill_no":"1000065","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"HEATHROW APT\/LONDON, HIL","supplierAddress":"500 SWEDES LANDING ROAD, WILMINGTON, DE 19801SDNF United States","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"}]
18-Jan-2021
13-Feb-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG...DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE

USFDA APPLICATION NUMBER - 205637

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DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG...DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE

USFDA APPLICATION NUMBER - 205637

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DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG B...DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE

USFDA APPLICATION NUMBER - 205637

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DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS...DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.4MG/0.4ML (0.4MG/0.4ML)

USFDA APPLICATION NUMBER - 205787

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DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0...DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20733

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DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2...DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20733

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DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS...DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML)

USFDA APPLICATION NUMBER - 209862

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DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BA...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE

USFDA APPLICATION NUMBER - 22410

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DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE

USFDA APPLICATION NUMBER - 22410

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DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE

USFDA APPLICATION NUMBER - 22410

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DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE

USFDA APPLICATION NUMBER - 22410

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ABOUT THIS PAGE

Looking for 357-08-4 / Naloxone Hydrochloride API manufacturers, exporters & distributors?

Naloxone Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Naloxone 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 Naloxone Hydrochloride manufacturer or Naloxone Hydrochloride supplier for your needs.

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

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

API | Excipient name

Naloxone Hydrochloride

Synonyms

Naloxone hcl, 357-08-4, Narcan, Narcanti, Naloxone (hydrochloride), Evzio

Cas Number

357-08-4

Unique Ingredient Identifier (UNII)

F850569PQR

About Naloxone Hydrochloride

A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.

Narcanti Manufacturers

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

Narcanti Suppliers

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

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

Narcanti USDMF

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

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

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

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

Narcanti KDMF

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

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

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

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

Narcanti CEP

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

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

Narcanti WC

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

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

Narcanti 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 Narcanti as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Narcanti GMP

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

Narcanti CoA

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

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

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