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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.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Neuland Laboratories- A dedicated 100% API provider.
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**Federal...DOSAGE - TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
19
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 Brintellix manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brintellix, including repackagers and relabelers. The FDA regulates Brintellix manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brintellix 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 Brintellix manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Brintellix supplier is an individual or a company that provides Brintellix active pharmaceutical ingredient (API) or Brintellix finished formulations upon request. The Brintellix suppliers may include Brintellix API manufacturers, exporters, distributors and traders.
click here to find a list of Brintellix suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Brintellix DMF (Drug Master File) is a document detailing the whole manufacturing process of Brintellix active pharmaceutical ingredient (API) in detail. Different forms of Brintellix DMFs exist exist since differing nations have different regulations, such as Brintellix USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Brintellix DMF submitted to regulatory agencies in the US is known as a USDMF. Brintellix USDMF includes data on Brintellix's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Brintellix USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Brintellix 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 Brintellix Drug Master File in Japan (Brintellix JDMF) empowers Brintellix 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 Brintellix JDMF during the approval evaluation for pharmaceutical products. At the time of Brintellix 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 Brintellix 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 Brintellix Drug Master File in Korea (Brintellix KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Brintellix. The MFDS reviews the Brintellix KDMF as part of the drug registration process and uses the information provided in the Brintellix KDMF to evaluate the safety and efficacy of the drug.
After submitting a Brintellix 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 Brintellix API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Brintellix suppliers with KDMF on PharmaCompass.
A Brintellix written confirmation (Brintellix WC) is an official document issued by a regulatory agency to a Brintellix manufacturer, verifying that the manufacturing facility of a Brintellix active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Brintellix APIs or Brintellix finished pharmaceutical products to another nation, regulatory agencies frequently require a Brintellix WC (written confirmation) as part of the regulatory process.
click here to find a list of Brintellix 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 Brintellix as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Brintellix 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 Brintellix 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 Brintellix and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Brintellix NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Brintellix suppliers with NDC on PharmaCompass.
Brintellix 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 Brintellix 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 Brintellix GMP manufacturer or Brintellix GMP API supplier for your needs.
A Brintellix CoA (Certificate of Analysis) is a formal document that attests to Brintellix's compliance with Brintellix specifications and serves as a tool for batch-level quality control.
Brintellix CoA mostly includes findings from lab analyses of a specific batch. For each Brintellix 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.
Brintellix may be tested according to a variety of international standards, such as European Pharmacopoeia (Brintellix EP), Brintellix JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Brintellix USP).
