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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
EU-WC
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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 :
Type : II
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34367
Submission : 2019-12-13
Status :
Type : II
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Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
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...
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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 Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nalmefene Hydrochloride , including repackagers and relabelers. The FDA regulates Nalmefene Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nalmefene Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nalmefene Hydrochloride supplier is an individual or a company that provides Nalmefene Hydrochloride active pharmaceutical ingredient (API) or Nalmefene Hydrochloride finished formulations upon request. The Nalmefene Hydrochloride suppliers may include Nalmefene Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Nalmefene Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nalmefene Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Nalmefene Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Nalmefene Hydrochloride DMFs exist exist since differing nations have different regulations, such as Nalmefene Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nalmefene Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Nalmefene Hydrochloride USDMF includes data on Nalmefene Hydrochloride 's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nalmefene Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nalmefene Hydrochloride 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 Nalmefene Hydrochloride Drug Master File in Japan (Nalmefene Hydrochloride JDMF) empowers Nalmefene Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Nalmefene Hydrochloride 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 Hydrochloride suppliers with JDMF on PharmaCompass.
A Nalmefene Hydrochloride written confirmation (Nalmefene Hydrochloride WC) is an official document issued by a regulatory agency to a Nalmefene Hydrochloride manufacturer, verifying that the manufacturing facility of a Nalmefene Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nalmefene Hydrochloride APIs or Nalmefene Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Nalmefene Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Nalmefene Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nalmefene Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nalmefene Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nalmefene Hydrochloride suppliers with NDC on PharmaCompass.
Nalmefene Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Nalmefene Hydrochloride GMP API supplier for your needs.
A Nalmefene Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Nalmefene Hydrochloride 's compliance with Nalmefene Hydrochloride specifications and serves as a tool for batch-level quality control.
Nalmefene Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Nalmefene Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Nalmefene Hydrochloride EP), Nalmefene Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nalmefene Hydrochloride USP).
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