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
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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
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-11-30
DMF Number : 21590
Submission : 2008-04-29
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
Veranova: A CDMO that manages complexity with confidence.
Certificate Number : R1-CEP 2008-058 - Rev 00
Status : Valid
Issue Date : 2014-09-12
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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Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Date of Issue : 2021-08-27
Valid Till : 2024-06-10
Written Confirmation Number : WC-0278
Address of the Firm : Plot No. 6406, GIDC Estate, Ankleshwar-393002, Dist. Bharuch, Gujarat
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2019-05-30
Registration Number : 20190530-209-J-359
Manufacturer Name : Sanofi Winthrop Industrie
Manufacturer Address : Route d'Avignon 30390 Aramon, France
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Registrant Name : Base Farm Co., Ltd.
Registration Date : 2021-09-30
Registration Number : 20210611-209-J-542(1)
Manufacturer Name : Rusan Pharma Ltd.
Manufacturer Address : Plot no. 6406, GIDC ESTATE, ANKLESHWAR, City : ANKLESHWAR - 393 002, Dist : Bharuch, ...
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Registrant Name : Phamchem Service Co., Ltd.
Registration Date : 2023-10-16
Registration Number : 20210611-209-J-542(2)
Manufacturer Name : Rusan Pharma Ltd.
Manufacturer Address : Plot no. 6406, GIDC ESTATE, ANKLESHWAR, City : ANKLESHWAR - 393 002, Dist : Bharuch, ...
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Registrant Name : Hiple Co., Ltd.
Registration Date : 2021-06-11
Registration Number : 20210611-209-J-542
Manufacturer Name : Rusan Pharma Ltd.
Manufacturer Address : Plot no. 6406, GIDC ESTATE, ANKLESHWAR, City : ANKLESHWAR - 393 002, Dist : Bharuch, ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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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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Fillers, Diluents & Binders
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Digital Content
NEWS #PharmaBuzz
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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 Trexan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trexan, including repackagers and relabelers. The FDA regulates Trexan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trexan 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 Trexan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trexan supplier is an individual or a company that provides Trexan active pharmaceutical ingredient (API) or Trexan finished formulations upon request. The Trexan suppliers may include Trexan API manufacturers, exporters, distributors and traders.
click here to find a list of Trexan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trexan DMF (Drug Master File) is a document detailing the whole manufacturing process of Trexan active pharmaceutical ingredient (API) in detail. Different forms of Trexan DMFs exist exist since differing nations have different regulations, such as Trexan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trexan DMF submitted to regulatory agencies in the US is known as a USDMF. Trexan USDMF includes data on Trexan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trexan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trexan 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 Trexan Drug Master File in Korea (Trexan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Trexan. The MFDS reviews the Trexan KDMF as part of the drug registration process and uses the information provided in the Trexan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Trexan 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 Trexan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Trexan suppliers with KDMF on PharmaCompass.
A Trexan CEP of the European Pharmacopoeia monograph is often referred to as a Trexan Certificate of Suitability (COS). The purpose of a Trexan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Trexan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Trexan to their clients by showing that a Trexan CEP has been issued for it. The manufacturer submits a Trexan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Trexan CEP holder for the record. Additionally, the data presented in the Trexan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Trexan DMF.
A Trexan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Trexan 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 Trexan suppliers with CEP (COS) on PharmaCompass.
A Trexan written confirmation (Trexan WC) is an official document issued by a regulatory agency to a Trexan manufacturer, verifying that the manufacturing facility of a Trexan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trexan APIs or Trexan finished pharmaceutical products to another nation, regulatory agencies frequently require a Trexan WC (written confirmation) as part of the regulatory process.
click here to find a list of Trexan 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 Trexan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trexan 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 Trexan 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 Trexan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trexan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trexan suppliers with NDC on PharmaCompass.
Trexan 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 Trexan 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 Trexan GMP manufacturer or Trexan GMP API supplier for your needs.
A Trexan CoA (Certificate of Analysis) is a formal document that attests to Trexan's compliance with Trexan specifications and serves as a tool for batch-level quality control.
Trexan CoA mostly includes findings from lab analyses of a specific batch. For each Trexan 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.
Trexan may be tested according to a variety of international standards, such as European Pharmacopoeia (Trexan EP), Trexan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trexan USP).
