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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Veranova: A CDMO that manages complexity with confidence.
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NDC
ROW
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Temad- We think of world-class quality.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
CEP/COS
JDMF
KDMF
CN
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Aspen API. More than just an API.
CEP/COS
NDC
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
EU-WC
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.
CEP/COS
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-26
DMF Number : 20745
Submission : 2007-07-31
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-15
Pay. Date : 2013-01-23
DMF Number : 23142
Submission : 2009-09-30
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-21
Pay. Date : 2015-09-10
DMF Number : 14034
Submission : 1999-03-19
Status :
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 :
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 :
Type : II
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API Imports and Exports
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Drugs in Development
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DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG...DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE
USFDA APPLICATION NUMBER - 205637
DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG...DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE
USFDA APPLICATION NUMBER - 205637
DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG B...DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE
USFDA APPLICATION NUMBER - 205637
DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS...DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 0.4MG/0.4ML (0.4MG/0.4ML)
USFDA APPLICATION NUMBER - 205787
DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0...DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20733
DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2...DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20733
DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS...DOSAGE - SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS - 2MG/0.4ML (2MG/0.4ML)
USFDA APPLICATION NUMBER - 209862
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BA...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE
USFDA APPLICATION NUMBER - 22410
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE
USFDA APPLICATION NUMBER - 22410
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE
USFDA APPLICATION NUMBER - 22410
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE
USFDA APPLICATION NUMBER - 22410
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Naloxone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naloxone, including repackagers and relabelers. The FDA regulates Naloxone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naloxone 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naloxone supplier is an individual or a company that provides Naloxone active pharmaceutical ingredient (API) or Naloxone finished formulations upon request. The Naloxone suppliers may include Naloxone API manufacturers, exporters, distributors and traders.
click here to find a list of Naloxone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Naloxone DMF (Drug Master File) is a document detailing the whole manufacturing process of Naloxone active pharmaceutical ingredient (API) in detail. Different forms of Naloxone DMFs exist exist since differing nations have different regulations, such as Naloxone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Naloxone DMF submitted to regulatory agencies in the US is known as a USDMF. Naloxone USDMF includes data on Naloxone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naloxone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Naloxone 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 Drug Master File in Japan (Naloxone JDMF) empowers Naloxone 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Naloxone 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 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 Drug Master File in Korea (Naloxone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Naloxone. The MFDS reviews the Naloxone KDMF as part of the drug registration process and uses the information provided in the Naloxone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Naloxone 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Naloxone suppliers with KDMF on PharmaCompass.
A Naloxone CEP of the European Pharmacopoeia monograph is often referred to as a Naloxone Certificate of Suitability (COS). The purpose of a Naloxone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Naloxone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Naloxone to their clients by showing that a Naloxone CEP has been issued for it. The manufacturer submits a Naloxone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Naloxone CEP holder for the record. Additionally, the data presented in the Naloxone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Naloxone DMF.
A Naloxone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Naloxone 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 suppliers with CEP (COS) on PharmaCompass.
A Naloxone written confirmation (Naloxone WC) is an official document issued by a regulatory agency to a Naloxone manufacturer, verifying that the manufacturing facility of a Naloxone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Naloxone APIs or Naloxone finished pharmaceutical products to another nation, regulatory agencies frequently require a Naloxone WC (written confirmation) as part of the regulatory process.
click here to find a list of Naloxone 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Naloxone 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Naloxone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Naloxone suppliers with NDC on PharmaCompass.
Naloxone 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 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 GMP manufacturer or Naloxone GMP API supplier for your needs.
A Naloxone CoA (Certificate of Analysis) is a formal document that attests to Naloxone's compliance with Naloxone specifications and serves as a tool for batch-level quality control.
Naloxone CoA mostly includes findings from lab analyses of a specific batch. For each Naloxone 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Naloxone EP), Naloxone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Naloxone USP).
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