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Looking for 960203-27-4 / Vortioxetine Hydrobromide API manufacturers, exporters & distributors?

Vortioxetine Hydrobromide manufacturers, exporters & distributors 1

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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.

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.

API | Excipient name

Vortioxetine Hydrobromide

Synonyms

960203-27-4, Vortioxetine hbr, Brintellix, Vortioxetine (lu aa21004) hbr, Trintellix, Vortioxetine (hydrobromide)

Cas Number

960203-27-4

Unique Ingredient Identifier (UNII)

TKS641KOAY

About Vortioxetine Hydrobromide

A piperazine derivative that acts as a serotonin reuptake inhibitor, as a 5-HT3 receptor antagonist, and 5-HT1A receptor agonist. It is used for the treatment of anxiety and depression.

Vortioxetine Manufacturers

A Vortioxetine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vortioxetine, including repackagers and relabelers. The FDA regulates Vortioxetine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vortioxetine 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 Vortioxetine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Vortioxetine Suppliers

A Vortioxetine supplier is an individual or a company that provides Vortioxetine active pharmaceutical ingredient (API) or Vortioxetine finished formulations upon request. The Vortioxetine suppliers may include Vortioxetine API manufacturers, exporters, distributors and traders.

click here to find a list of Vortioxetine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Vortioxetine USDMF

A Vortioxetine DMF (Drug Master File) is a document detailing the whole manufacturing process of Vortioxetine active pharmaceutical ingredient (API) in detail. Different forms of Vortioxetine DMFs exist exist since differing nations have different regulations, such as Vortioxetine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Vortioxetine DMF submitted to regulatory agencies in the US is known as a USDMF. Vortioxetine USDMF includes data on Vortioxetine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vortioxetine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Vortioxetine suppliers with USDMF on PharmaCompass.

Vortioxetine JDMF

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 Vortioxetine Drug Master File in Japan (Vortioxetine JDMF) empowers Vortioxetine 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 Vortioxetine JDMF during the approval evaluation for pharmaceutical products. At the time of Vortioxetine 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 Vortioxetine suppliers with JDMF on PharmaCompass.

Vortioxetine KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Vortioxetine Drug Master File in Korea (Vortioxetine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vortioxetine. The MFDS reviews the Vortioxetine KDMF as part of the drug registration process and uses the information provided in the Vortioxetine KDMF to evaluate the safety and efficacy of the drug.

After submitting a Vortioxetine 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 Vortioxetine API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Vortioxetine suppliers with KDMF on PharmaCompass.

Vortioxetine WC

A Vortioxetine written confirmation (Vortioxetine WC) is an official document issued by a regulatory agency to a Vortioxetine manufacturer, verifying that the manufacturing facility of a Vortioxetine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vortioxetine APIs or Vortioxetine finished pharmaceutical products to another nation, regulatory agencies frequently require a Vortioxetine WC (written confirmation) as part of the regulatory process.

click here to find a list of Vortioxetine suppliers with Written Confirmation (WC) on PharmaCompass.

Vortioxetine NDC

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 Vortioxetine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Vortioxetine API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Vortioxetine 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Vortioxetine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vortioxetine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Vortioxetine suppliers with NDC on PharmaCompass.

Vortioxetine GMP

Vortioxetine 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 Vortioxetine 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 Vortioxetine GMP manufacturer or Vortioxetine GMP API supplier for your needs.

Vortioxetine CoA

A Vortioxetine CoA (Certificate of Analysis) is a formal document that attests to Vortioxetine's compliance with Vortioxetine specifications and serves as a tool for batch-level quality control.

Vortioxetine CoA mostly includes findings from lab analyses of a specific batch. For each Vortioxetine 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.

Vortioxetine may be tested according to a variety of international standards, such as European Pharmacopoeia (Vortioxetine EP), Vortioxetine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vortioxetine USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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