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1. 6-desoxy-6-methylenenaltrexone
2. Nalmefene
3. Revex
4. Selincro
1. 58895-64-0
2. Nalmefene Hcl
3. Revex
4. Nalmefenehydrochloride
5. Jf-1 Hydrochloride
6. K7k69qc05x
7. (4r,4as,7as,12bs)-3-(cyclopropylmethyl)-7-methylidene-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-4a,9-diol;hydrochloride
8. Unii-k7k69qc05x
9. Revex (tn)
10. 17-(cyclopropylmethyl)-4,5alpha-epoxy-6-methylenemorphinan-3,14-diol, , Hydrochloride
11. Schembl628721
12. Chembl1201152
13. Dtxsid70891705
14. Bcp08346
15. Nalmefene Hydrochloride [mi]
16. Mfcd27937056
17. Akos016340557
18. Ccg-221179
19. Hs-0037
20. Nalmefene Hydrochloride [mart.]
21. Nalmefene Hydrochloride [vandf]
22. Nalmefene Hydrochloride [who-dd]
23. Morphinan-3,14-diol, 17-(cyclopropylmethyl)-4,5-epoxy-6-methylene-, Hydrochloride, (5alpha)-
24. B7584
25. Nalmefene Hydrochloride [orange Book]
26. D02104
27. Sr-01000000007
28. Sr-01000000007-2
29. Q27282058
30. 17-cyclopropylmethyl-4,5a-epoxy-6-methylenemorphinan-3,14-diol
31. (5?)-17-(cyclopropylmethyl)-4,5-epoxy-6-methylenemorphinan-3,14-diol Hydrochloride
32. 17-cyclopropylmethyl-4,5a-epoxy-6-methylenemorphinan-3,14-diol Hydrochloride
33. (4r,4as,7as,12bs)-3-(cyclopropylmethyl)-7-methylidene-2,4,5,6,7a,13-hexahydro-1h-4,12-methanobenzofuro[3,2-e]isoquinoline-4a,9-diol,hydrochloride
| Molecular Weight | 375.9 g/mol |
|---|---|
| Molecular Formula | C21H26ClNO3 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 2 |
| Exact Mass | 375.1601214 g/mol |
| Monoisotopic Mass | 375.1601214 g/mol |
| Topological Polar Surface Area | 52.9 Ų |
| Heavy Atom Count | 26 |
| Formal Charge | 0 |
| Complexity | 618 |
| 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 |
Narcotic Antagonists
Agents inhibiting the effect of narcotics on the central nervous system. (See all compounds classified as Narcotic Antagonists.)
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5484
Submission : 1984-08-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34367
Submission : 2019-12-13
Status : Active
Type : II
Date of Issue : 2025-02-11
Valid Till : 2027-06-09
Written Confirmation Number : WC-0278
Address of the Firm :
NDC Package Code : 73548-8019
Start Marketing Date : 2024-09-02
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-08-25
Pay. Date : 2019-08-22
DMF Number : 15663
Submission : 2001-10-10
Status : Active
Type : II
NDC Package Code : 0406-1340
Start Marketing Date : 2025-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35829
Submission : 2021-11-10
Status : Active
Type : II
NDC Package Code : 0406-5690
Start Marketing Date : 2019-03-03
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8507
Submission : 1990-03-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5642
Submission : 1984-12-17
Status : Inactive
Type : II



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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Details:
Nalmefene is a Small Molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of Opioid-Related Disorders.
Lead Product(s): Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: National Institute on Drug Abuse
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 08, 2026

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Lead Product(s) : Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : National Institute on Drug Abuse
Deal Size : Inapplicable
Deal Type : Inapplicable
Nalmefene Implant in Healthy Subjects
Details : Nalmefene is a Small Molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of Opioid-Related Disorders.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 08, 2026

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Details:
Nalmefene, a miscellaneous product, targets Delta, Kappa, and Mu-type opioid receptors to address respiratory depression caused by fentanyl and other ultrapotent opioids.
Lead Product(s): Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 13, 2025

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Lead Product(s) : Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Tharimmune Gets FDA Nod for TH104 Prophylaxis Against Respiratory Depression by Fentanyl
Details : Nalmefene, a miscellaneous product, targets Delta, Kappa, and Mu-type opioid receptors to address respiratory depression caused by fentanyl and other ultrapotent opioids.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 13, 2025

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Details:
TH104 is a buccal film formulation, of nalmefene specifically designed for rapid absorption with a potential for bypassing liver metabolism.
Lead Product(s): Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 06, 2025

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Lead Product(s) : Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Tharimmune Shows Positive Data on TH104 for Ultrapotent Opioid Prophylaxis
Details : TH104 is a buccal film formulation, of nalmefene specifically designed for rapid absorption with a potential for bypassing liver metabolism.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 06, 2025

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Details:
TH104 is a buccal film formulation, of nalmefene specifically designed for rapid absorption with a potential for bypassing liver metabolism.
Lead Product(s): Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 28, 2025

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Lead Product(s) : Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Tharimmune Advances TH104 for Fentanyl Defense After FDA Positive Feedback
Details : TH104 is a buccal film formulation, of nalmefene specifically designed for rapid absorption with a potential for bypassing liver metabolism.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 28, 2025

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Details:
Tharimmune is seeking to develop TH104 for "Temporary Prophylaxis of Respiratory or Nervous System Depression in Military Personnel and Chemical Incident Responders".
Lead Product(s): Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: IND EnablingProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 31, 2025

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Lead Product(s) : Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : IND Enabling
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Tharimmune gets FDA Feedback on NDA Path for TH104 in Opioid Exposure
Details : Tharimmune is seeking to develop TH104 for "Temporary Prophylaxis of Respiratory or Nervous System Depression in Military Personnel and Chemical Incident Responders".
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 31, 2025

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Details:
Nalmefene is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pruritus.
Lead Product(s): Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 13, 2024

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Lead Product(s) : Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis
Details : Nalmefene is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pruritus.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 13, 2024

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Details:
Nalmefene HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Opiate Overdose.
Lead Product(s): Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 06, 2024

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Lead Product(s) : Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Nalmefene HCl is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Opiate Overdose.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 06, 2024

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Details:
Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids.
Lead Product(s): Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Zurnai
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 30, 2024

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Lead Product(s) : Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Study on Nalmefene Injection For Opioid Overdose in ERs Concludes
Details : Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids.
Product Name : Zurnai
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 30, 2024

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Details:
Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids.
Lead Product(s): Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Zurnai
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 07, 2024

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Lead Product(s) : Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose
Details : Nalmefene Hydrochloride Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids.
Product Name : Zurnai
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 07, 2024

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Details:
Zurnai (nalmefene hydrochloride) Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids.
Lead Product(s): Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Zurnai
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 07, 2024

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Lead Product(s) : Nalmefene Hydrochloride ,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves Zurnai™ Auto-Injector for Opioid Overdose Treatment in Adults and Children
Details : Zurnai (nalmefene hydrochloride) Injection is indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids.
Product Name : Zurnai
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 07, 2024

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20 Aug 2025
// ACCESSWIRE
https://www.accessnewswire.com/newsroom/en/biotechnology/tharimmune-reports-pharmacokinetic-simulation-results-for-th104-as-prophylaxis-agains-1062977

19 May 2025
// FDA
https://www.pharmacompass.com/pdf/news/fda-confirms-para-iv-patent-litigation-for-opvee-spray-49094.pdf

28 Oct 2024
// BUSINESSWIRE

09 Aug 2024
// FDA
https://www.fda.gov/news-events/press-announcements/fda-approves-first-nalmefene-hydrochloride-auto-injector-reverse-opioid-overdose

07 Aug 2024
// BUSINESSWIRE

08 Apr 2024
// BUSINESSWIRE
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PharmaCompass offers a list of Nalmefene 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 Nalmefene Hydrochloride manufacturer or Nalmefene Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nalmefene Hydrochloride manufacturer or Nalmefene Hydrochloride supplier.
PharmaCompass also assists you with knowing the Nalmefene Hydrochloride API Price utilized in the formulation of products. Nalmefene Hydrochloride API Price is not always fixed or binding as the Nalmefene Hydrochloride Price is obtained through a variety of data sources. The Nalmefene Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nalmefene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nalmefene, including repackagers and relabelers. The FDA regulates Nalmefene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nalmefene 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 Nalmefene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nalmefene supplier is an individual or a company that provides Nalmefene active pharmaceutical ingredient (API) or Nalmefene finished formulations upon request. The Nalmefene suppliers may include Nalmefene API manufacturers, exporters, distributors and traders.
click here to find a list of Nalmefene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nalmefene DMF (Drug Master File) is a document detailing the whole manufacturing process of Nalmefene active pharmaceutical ingredient (API) in detail. Different forms of Nalmefene DMFs exist exist since differing nations have different regulations, such as Nalmefene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nalmefene DMF submitted to regulatory agencies in the US is known as a USDMF. Nalmefene USDMF includes data on Nalmefene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nalmefene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nalmefene suppliers with USDMF on PharmaCompass.
A Nalmefene written confirmation (Nalmefene WC) is an official document issued by a regulatory agency to a Nalmefene manufacturer, verifying that the manufacturing facility of a Nalmefene active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nalmefene APIs or Nalmefene finished pharmaceutical products to another nation, regulatory agencies frequently require a Nalmefene WC (written confirmation) as part of the regulatory process.
click here to find a list of Nalmefene 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 Nalmefene as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nalmefene 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 Nalmefene 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 Nalmefene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nalmefene NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nalmefene suppliers with NDC on PharmaCompass.
Nalmefene 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 Nalmefene 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 Nalmefene GMP manufacturer or Nalmefene GMP API supplier for your needs.
A Nalmefene CoA (Certificate of Analysis) is a formal document that attests to Nalmefene's compliance with Nalmefene specifications and serves as a tool for batch-level quality control.
Nalmefene CoA mostly includes findings from lab analyses of a specific batch. For each Nalmefene 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.
Nalmefene may be tested according to a variety of international standards, such as European Pharmacopoeia (Nalmefene EP), Nalmefene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nalmefene USP).