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CEP/COS
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Australia
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41091
Submission : 2024-12-31
Status :
Type : II
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DOSAGE - TABLET;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 204447
DOSAGE - TABLET;ORAL - EQ 15MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 204447
DOSAGE - TABLET;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 204447
DOSAGE - TABLET;ORAL - EQ 5MG BASE
USFDA APPLICATION NUMBER - 204447
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ABOUT THIS PAGE
57
PharmaCompass offers a list of Vortioxetine Hydrobromide 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 Vortioxetine Hydrobromide manufacturer or Vortioxetine Hydrobromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vortioxetine Hydrobromide manufacturer or Vortioxetine Hydrobromide supplier.
PharmaCompass also assists you with knowing the Vortioxetine Hydrobromide API Price utilized in the formulation of products. Vortioxetine Hydrobromide API Price is not always fixed or binding as the Vortioxetine Hydrobromide Price is obtained through a variety of data sources. The Vortioxetine Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A TRINTELLIX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of TRINTELLIX, including repackagers and relabelers. The FDA regulates TRINTELLIX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. TRINTELLIX 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 TRINTELLIX manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A TRINTELLIX supplier is an individual or a company that provides TRINTELLIX active pharmaceutical ingredient (API) or TRINTELLIX finished formulations upon request. The TRINTELLIX suppliers may include TRINTELLIX API manufacturers, exporters, distributors and traders.
click here to find a list of TRINTELLIX suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A TRINTELLIX DMF (Drug Master File) is a document detailing the whole manufacturing process of TRINTELLIX active pharmaceutical ingredient (API) in detail. Different forms of TRINTELLIX DMFs exist exist since differing nations have different regulations, such as TRINTELLIX USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A TRINTELLIX DMF submitted to regulatory agencies in the US is known as a USDMF. TRINTELLIX USDMF includes data on TRINTELLIX's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The TRINTELLIX USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of TRINTELLIX 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 TRINTELLIX Drug Master File in Japan (TRINTELLIX JDMF) empowers TRINTELLIX 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 TRINTELLIX JDMF during the approval evaluation for pharmaceutical products. At the time of TRINTELLIX 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 TRINTELLIX 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 TRINTELLIX Drug Master File in Korea (TRINTELLIX KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of TRINTELLIX. The MFDS reviews the TRINTELLIX KDMF as part of the drug registration process and uses the information provided in the TRINTELLIX KDMF to evaluate the safety and efficacy of the drug.
After submitting a TRINTELLIX 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 TRINTELLIX API can apply through the Korea Drug Master File (KDMF).
click here to find a list of TRINTELLIX suppliers with KDMF on PharmaCompass.
A TRINTELLIX written confirmation (TRINTELLIX WC) is an official document issued by a regulatory agency to a TRINTELLIX manufacturer, verifying that the manufacturing facility of a TRINTELLIX active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting TRINTELLIX APIs or TRINTELLIX finished pharmaceutical products to another nation, regulatory agencies frequently require a TRINTELLIX WC (written confirmation) as part of the regulatory process.
click here to find a list of TRINTELLIX 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 TRINTELLIX as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for TRINTELLIX 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 TRINTELLIX 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 TRINTELLIX and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a TRINTELLIX NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of TRINTELLIX suppliers with NDC on PharmaCompass.
TRINTELLIX 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 TRINTELLIX 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 TRINTELLIX GMP manufacturer or TRINTELLIX GMP API supplier for your needs.
A TRINTELLIX CoA (Certificate of Analysis) is a formal document that attests to TRINTELLIX's compliance with TRINTELLIX specifications and serves as a tool for batch-level quality control.
TRINTELLIX CoA mostly includes findings from lab analyses of a specific batch. For each TRINTELLIX 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.
TRINTELLIX may be tested according to a variety of international standards, such as European Pharmacopoeia (TRINTELLIX EP), TRINTELLIX JP (Japanese Pharmacopeia) and the US Pharmacopoeia (TRINTELLIX USP).
