Synopsis
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JDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Temad- We think of world-class quality.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
CEP/COS 
KDMF
CN
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Aspen API. More than just an API™
Product Not Available For Sales
NDC
Jai Radhe Sales is your partner for all your sourcing needs.
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
EU-WC
NDC
KDMF
Deccan Nutraceuticals: A global leader in the integrated development, manufacturing, and marketing of pharmaceutical products.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
CEP/COS
NDC
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USDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-17
Pay. Date : 2013-03-11
DMF Number : 20623
Submission : 2007-06-20
Status :
Type : II
Aspen API. More than just an API™
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-16
Pay. Date : 2012-12-20
DMF Number : 15102
Submission : 2000-10-18
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-12-20
DMF Number : 23325
Submission : 2009-12-01
Status :
Type : II
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : CEP 2009-287 - Rev 03
Status : Valid
Issue Date : 2024-03-01
Type : Chemical
Substance Number : 1790
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Certificate Number : R1-CEP 2016-053 - Rev 00
Status : Valid
Issue Date : 2023-01-13
Type : Chemical
Substance Number : 1790
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
Naltrexone Hydrochloride, Wavelength Site
Certificate Number : CEP 2020-291 - Rev 02
Status : Valid
Issue Date : 2024-04-23
Type : Chemical
Substance Number : 1790
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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Drugs in Development
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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
CAS Number : 7051-34-5
End Use API : Naltrexone Hydrochloride
About The Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&...
M2i Group, an integrated CDMO, is your French partner for development & manufacturing in fine chemistry.
CAS Number : 7051-34-5
End Use API : Naltrexone Hydrochloride
About The Company : Integrated solutions for all your projects.
M2i Group provides integrated solutions for all your projects. We offer our clients an integrated partner, fr...
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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 90MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG
USFDA APPLICATION NUMBER - 200063
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 100MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 30MG;1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 50MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 60MG;2.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 80M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 80MG;3.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22321
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PharmaCompass offers a list of Naltrexone 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 Naltrexone Hydrochloride manufacturer or Naltrexone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Naltrexone Hydrochloride manufacturer or Naltrexone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Naltrexone Hydrochloride API Price utilized in the formulation of products. Naltrexone Hydrochloride API Price is not always fixed or binding as the Naltrexone Hydrochloride Price is obtained through a variety of data sources. The Naltrexone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Naltrexone HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naltrexone HCl, including repackagers and relabelers. The FDA regulates Naltrexone HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naltrexone HCl 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 Naltrexone HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naltrexone HCl supplier is an individual or a company that provides Naltrexone HCl active pharmaceutical ingredient (API) or Naltrexone HCl finished formulations upon request. The Naltrexone HCl suppliers may include Naltrexone HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Naltrexone HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Naltrexone HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Naltrexone HCl active pharmaceutical ingredient (API) in detail. Different forms of Naltrexone HCl DMFs exist exist since differing nations have different regulations, such as Naltrexone HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Naltrexone HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Naltrexone HCl USDMF includes data on Naltrexone HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naltrexone HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Naltrexone HCl suppliers with USDMF 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 Naltrexone HCl Drug Master File in Korea (Naltrexone HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naltrexone HCl. The MFDS reviews the Naltrexone HCl KDMF as part of the drug registration process and uses the information provided in the Naltrexone HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Naltrexone HCl 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 Naltrexone HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Naltrexone HCl suppliers with KDMF on PharmaCompass.
A Naltrexone HCl CEP of the European Pharmacopoeia monograph is often referred to as a Naltrexone HCl Certificate of Suitability (COS). The purpose of a Naltrexone HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Naltrexone HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Naltrexone HCl to their clients by showing that a Naltrexone HCl CEP has been issued for it. The manufacturer submits a Naltrexone HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Naltrexone HCl CEP holder for the record. Additionally, the data presented in the Naltrexone HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Naltrexone HCl DMF.
A Naltrexone HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Naltrexone HCl 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 Naltrexone HCl suppliers with CEP (COS) on PharmaCompass.
A Naltrexone HCl written confirmation (Naltrexone HCl WC) is an official document issued by a regulatory agency to a Naltrexone HCl manufacturer, verifying that the manufacturing facility of a Naltrexone HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naltrexone HCl APIs or Naltrexone HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Naltrexone HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Naltrexone HCl 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 Naltrexone HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Naltrexone HCl 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 Naltrexone HCl 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 Naltrexone HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naltrexone HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Naltrexone HCl suppliers with NDC on PharmaCompass.
Naltrexone HCl 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 Naltrexone HCl 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 Naltrexone HCl GMP manufacturer or Naltrexone HCl GMP API supplier for your needs.
A Naltrexone HCl CoA (Certificate of Analysis) is a formal document that attests to Naltrexone HCl's compliance with Naltrexone HCl specifications and serves as a tool for batch-level quality control.
Naltrexone HCl CoA mostly includes findings from lab analyses of a specific batch. For each Naltrexone HCl 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.
Naltrexone HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Naltrexone HCl EP), Naltrexone HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naltrexone HCl USP).
