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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
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
Molecular Weight | 363.8 g/mol |
---|---|
Molecular Formula | C19H22ClNO4 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 2 |
Exact Mass | 363.1237359 g/mol |
Monoisotopic Mass | 363.1237359 g/mol |
Topological Polar Surface Area | 70 Ų |
Heavy Atom Count | 25 |
Formal Charge | 0 |
Complexity | 594 |
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 |
1 of 4 | |
---|---|
Drug Name | Evzio |
PubMed Health | Naloxone (Injection) |
Drug Classes | Toxicology-Antidote Agent |
Drug Label | EVZIO (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 Ingredient | Naloxone hydrochloride |
Dosage Form | Solution |
Route | Intramuscular, subcutaneous |
Strength | 0.4mg/0.4ml |
Market Status | Prescription |
Company | Kaleo |
2 of 4 | |
---|---|
Drug Name | Naloxone hydrochloride |
Drug Label | Ampul, 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 Ingredient | Naloxone hydrochloride |
Dosage Form | Injectable |
Route | Injection |
Strength | 1mg/ml; 0.4mg/ml |
Market Status | Prescription |
Company | Hospira; Intl Medication; Mylan Institutional |
3 of 4 | |
---|---|
Drug Name | Evzio |
PubMed Health | Naloxone (Injection) |
Drug Classes | Toxicology-Antidote Agent |
Drug Label | EVZIO (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 Ingredient | Naloxone hydrochloride |
Dosage Form | Solution |
Route | Intramuscular, subcutaneous |
Strength | 0.4mg/0.4ml |
Market Status | Prescription |
Company | Kaleo |
4 of 4 | |
---|---|
Drug Name | Naloxone hydrochloride |
Drug Label | Ampul, 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 Ingredient | Naloxone hydrochloride |
Dosage Form | Injectable |
Route | Injection |
Strength | 1mg/ml; 0.4mg/ml |
Market Status | Prescription |
Company | Hospira; Intl Medication; Mylan Institutional |
Treatment of opioid-induced constipation
Narcotic Antagonists
Agents inhibiting the effect of narcotics on the central nervous system. (See all compounds classified as Narcotic Antagonists.)
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-23
Pay. Date : 2012-11-26
DMF Number : 20745
Submission : 2007-07-31
Status : Active
Type : II
Certificate Number : R1-CEP 2006-261 - Rev 04
Issue Date : 2020-02-21
Type : Chemical
Substance Number : 729
Status : Valid
NDC Package Code : 12707-037
Start Marketing Date : 2017-12-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Available Reg Filing : ROW |
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-15
Pay. Date : 2013-01-23
DMF Number : 23142
Submission : 2009-09-30
Status : Active
Type : II
Certificate Number : CEP 1996-050 - Rev 07
Issue Date : 2024-02-22
Type : Chemical
Substance Number : 729
Status : Valid
Registration Number : 218MF10971
Registrant's Address : 82 Avenue Raspail 94250 Gentilly France
Initial Date of Registration : 2006-12-01
Latest Date of Registration : --
Registrant Name : Korea Mundi Pharma Co., Ltd.
Registration Date : 2013-06-14
Registration Number : 20130507-176-I-164-01(1)
Manufacturer Name : Sanofi Chimie
Manufacturer Address : Route d'Avignon 30390 Aramon France
Available Reg Filing : CN |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-21
Pay. Date : 2015-09-10
DMF Number : 14034
Submission : 1999-03-19
Status : Active
Type : II
Certificate Number : R1-CEP 1996-074 - Rev 06
Issue Date : 2014-01-23
Type : Chemical
Substance Number : 729
Status : Valid
NDC Package Code : 60870-0288
Start Marketing Date : 1986-10-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2022-086 - Rev 00
Issue Date : 2024-03-28
Type : Chemical
Substance Number : 729
Status : Valid
Date of Issue : 2021-08-27
Valid Till : 2024-06-10
Written Confirmation Number : WC-0278
Address of the Firm :
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-14
Pay. Date : 2012-12-07
DMF Number : 24633
Submission : 2011-02-15
Status : Active
Type : II
Certificate Number : CEP 2011-055 - Rev 03
Issue Date : 2023-09-06
Type : Chemical
Substance Number : 729
Status : Valid
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-26
DMF Number : 20745
Submission : 2007-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-15
Pay. Date : 2013-01-23
DMF Number : 23142
Submission : 2009-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-21
Pay. Date : 2015-09-10
DMF Number : 14034
Submission : 1999-03-19
Status : Active
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-03
Pay. Date : 2014-10-14
DMF Number : 28226
Submission : 2014-08-13
Status : Active
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2013-06-14
Pay. Date : 2012-12-07
DMF Number : 24633
Submission : 2011-02-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4595
Submission : 1982-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7138
Submission : 1987-09-04
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2012-12-07
DMF Number : 1862
Submission : 1972-01-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6153
Submission : 1986-01-02
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-14
Pay. Date : 2020-01-09
DMF Number : 23389
Submission : 2010-02-22
Status : Active
Type : II
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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ABOUT THIS PAGE
A Naloxone Hydrochloride Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naloxone Hydrochloride Dihydrate, including repackagers and relabelers. The FDA regulates Naloxone Hydrochloride Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naloxone Hydrochloride Dihydrate 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 Naloxone Hydrochloride Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naloxone Hydrochloride Dihydrate supplier is an individual or a company that provides Naloxone Hydrochloride Dihydrate active pharmaceutical ingredient (API) or Naloxone Hydrochloride Dihydrate finished formulations upon request. The Naloxone Hydrochloride Dihydrate suppliers may include Naloxone Hydrochloride Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Naloxone Hydrochloride Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Naloxone Hydrochloride Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Naloxone Hydrochloride Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Naloxone Hydrochloride Dihydrate DMFs exist exist since differing nations have different regulations, such as Naloxone Hydrochloride Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Naloxone Hydrochloride Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Naloxone Hydrochloride Dihydrate USDMF includes data on Naloxone Hydrochloride Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naloxone Hydrochloride Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Naloxone Hydrochloride Dihydrate suppliers with USDMF on PharmaCompass.
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 Naloxone Hydrochloride Dihydrate Drug Master File in Japan (Naloxone Hydrochloride Dihydrate JDMF) empowers Naloxone Hydrochloride Dihydrate 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 Naloxone Hydrochloride Dihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Naloxone Hydrochloride Dihydrate 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 Naloxone Hydrochloride Dihydrate suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Naloxone Hydrochloride Dihydrate Drug Master File in Korea (Naloxone Hydrochloride Dihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naloxone Hydrochloride Dihydrate. The MFDS reviews the Naloxone Hydrochloride Dihydrate KDMF as part of the drug registration process and uses the information provided in the Naloxone Hydrochloride Dihydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Naloxone Hydrochloride Dihydrate 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 Naloxone Hydrochloride Dihydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Naloxone Hydrochloride Dihydrate suppliers with KDMF on PharmaCompass.
A Naloxone Hydrochloride Dihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Naloxone Hydrochloride Dihydrate Certificate of Suitability (COS). The purpose of a Naloxone Hydrochloride Dihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Naloxone Hydrochloride Dihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Naloxone Hydrochloride Dihydrate to their clients by showing that a Naloxone Hydrochloride Dihydrate CEP has been issued for it. The manufacturer submits a Naloxone Hydrochloride Dihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Naloxone Hydrochloride Dihydrate CEP holder for the record. Additionally, the data presented in the Naloxone Hydrochloride Dihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Naloxone Hydrochloride Dihydrate DMF.
A Naloxone Hydrochloride Dihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Naloxone Hydrochloride Dihydrate 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 Naloxone Hydrochloride Dihydrate suppliers with CEP (COS) on PharmaCompass.
A Naloxone Hydrochloride Dihydrate written confirmation (Naloxone Hydrochloride Dihydrate WC) is an official document issued by a regulatory agency to a Naloxone Hydrochloride Dihydrate manufacturer, verifying that the manufacturing facility of a Naloxone Hydrochloride Dihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naloxone Hydrochloride Dihydrate APIs or Naloxone Hydrochloride Dihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Naloxone Hydrochloride Dihydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Naloxone Hydrochloride Dihydrate suppliers with Written Confirmation (WC) on PharmaCompass.
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 Naloxone Hydrochloride Dihydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Naloxone Hydrochloride Dihydrate API and other APIs are published in this directory by the FDA.
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 Naloxone Hydrochloride Dihydrate 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.
The NDC directory also contains data on finished compounded human drug products that contain Naloxone Hydrochloride Dihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naloxone Hydrochloride Dihydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Naloxone Hydrochloride Dihydrate suppliers with NDC on PharmaCompass.
Naloxone Hydrochloride Dihydrate 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 Naloxone Hydrochloride Dihydrate 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 Naloxone Hydrochloride Dihydrate GMP manufacturer or Naloxone Hydrochloride Dihydrate GMP API supplier for your needs.
A Naloxone Hydrochloride Dihydrate CoA (Certificate of Analysis) is a formal document that attests to Naloxone Hydrochloride Dihydrate's compliance with Naloxone Hydrochloride Dihydrate specifications and serves as a tool for batch-level quality control.
Naloxone Hydrochloride Dihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Naloxone Hydrochloride Dihydrate 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.
Naloxone Hydrochloride Dihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Naloxone Hydrochloride Dihydrate EP), Naloxone Hydrochloride Dihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naloxone Hydrochloride Dihydrate USP).
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