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List of Drug Master Files (JDMF) for Nalmefene Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 H. Lundbeck A/S (1)

02 Lundbeck Pharmaceuticals Italy S. p. A (1)

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01 Nalmefene hydrochloride hydrate (2)

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01 Denmark (2)

URL Supplier Web Content
229MF10110
Via Quarta Strada, 2 Padova, Italy
2018-07-03
2017-06-26
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URL Supplier Web Content
229MF10109
Ottiliavej 9, DK-2500 Valby, Copenh...
2018-07-03
2017-06-26
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Looking for 58895-64-0 / Nalmefene Hydrochloride API manufacturers, exporters & distributors?

Nalmefene Hydrochloride manufacturers, exporters & distributors 1

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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.

API | Excipient name

Nalmefene Hydrochloride

Synonyms

58895-64-0, Nalmefene hcl, Revex, Nalmefenehydrochloride, Jf-1 hydrochloride, K7k69qc05x

Cas Number

58895-64-0

Unique Ingredient Identifier (UNII)

K7K69QC05X

About Nalmefene Hydrochloride

Nalmefene Hydrochloride is the hydrochloride salt form of nalmefene, a naltrexone analogue with opioid antagonistic property. Nalmefene antagonizes the effects of opioids by competing for the opioid receptors in the CNS. This results in reversal of the effects of the opioids, including reversal of analgesia, euphoria, respiratory depression, hypotension, sedation and physical dependence.

Nalmefene Manufacturers

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.

Nalmefene Suppliers

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.

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

Nalmefene Manufacturers | Traders | Suppliers

Nalmefene Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Nalmefene

Get in contact with the supplier of your choice:

  1. H. Lundbeck AS
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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