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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.
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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 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide, including repackagers and relabelers. The FDA regulates 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide supplier is an individual or a company that provides 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide active pharmaceutical ingredient (API) or 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide finished formulations upon request. The 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide suppliers may include 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide API manufacturers, exporters, distributors and traders.
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A 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide DMF (Drug Master File) is a document detailing the whole manufacturing process of 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide active pharmaceutical ingredient (API) in detail. Different forms of 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide DMFs exist exist since differing nations have different regulations, such as 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide DMF submitted to regulatory agencies in the US is known as a USDMF. 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide USDMF includes data on 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide Drug Master File in Japan (1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide JDMF) empowers 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide 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 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide JDMF during the approval evaluation for pharmaceutical products. At the time of 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide Drug Master File in Korea (1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide. The MFDS reviews the 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide KDMF as part of the drug registration process and uses the information provided in the 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide 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 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide API can apply through the Korea Drug Master File (KDMF).
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A 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide written confirmation (1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide WC) is an official document issued by a regulatory agency to a 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide manufacturer, verifying that the manufacturing facility of a 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide APIs or 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide finished pharmaceutical products to another nation, regulatory agencies frequently require a 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide WC (written confirmation) as part of the regulatory process.
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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 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide 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 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide 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 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide NDC to their finished compounded human drug products, they may choose to do so.
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1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide 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 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide 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 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide GMP manufacturer or 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide GMP API supplier for your needs.
A 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide CoA (Certificate of Analysis) is a formal document that attests to 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide's compliance with 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide specifications and serves as a tool for batch-level quality control.
1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide CoA mostly includes findings from lab analyses of a specific batch. For each 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide 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.
1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide may be tested according to a variety of international standards, such as European Pharmacopoeia (1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide EP), 1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1-[2-(2,4-dimethylphenyl)sulfanylphenyl]piperazine;hydrobromide USP).
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