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PharmaCompass offers a list of Mirtazapine 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 Mirtazapine manufacturer or Mirtazapine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mirtazapine manufacturer or Mirtazapine supplier.
PharmaCompass also assists you with knowing the Mirtazapine API Price utilized in the formulation of products. Mirtazapine API Price is not always fixed or binding as the Mirtazapine Price is obtained through a variety of data sources. The Mirtazapine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mirtazapine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirtazapine, including repackagers and relabelers. The FDA regulates Mirtazapine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirtazapine 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 Mirtazapine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mirtazapine supplier is an individual or a company that provides Mirtazapine active pharmaceutical ingredient (API) or Mirtazapine finished formulations upon request. The Mirtazapine suppliers may include Mirtazapine API manufacturers, exporters, distributors and traders.
click here to find a list of Mirtazapine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mirtazapine DMF (Drug Master File) is a document detailing the whole manufacturing process of Mirtazapine active pharmaceutical ingredient (API) in detail. Different forms of Mirtazapine DMFs exist exist since differing nations have different regulations, such as Mirtazapine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mirtazapine DMF submitted to regulatory agencies in the US is known as a USDMF. Mirtazapine USDMF includes data on Mirtazapine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mirtazapine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mirtazapine 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 Mirtazapine Drug Master File in Japan (Mirtazapine JDMF) empowers Mirtazapine 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 Mirtazapine JDMF during the approval evaluation for pharmaceutical products. At the time of Mirtazapine 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 Mirtazapine 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 Mirtazapine Drug Master File in Korea (Mirtazapine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mirtazapine. The MFDS reviews the Mirtazapine KDMF as part of the drug registration process and uses the information provided in the Mirtazapine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mirtazapine 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 Mirtazapine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mirtazapine suppliers with KDMF on PharmaCompass.
A Mirtazapine CEP of the European Pharmacopoeia monograph is often referred to as a Mirtazapine Certificate of Suitability (COS). The purpose of a Mirtazapine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mirtazapine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mirtazapine to their clients by showing that a Mirtazapine CEP has been issued for it. The manufacturer submits a Mirtazapine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mirtazapine CEP holder for the record. Additionally, the data presented in the Mirtazapine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mirtazapine DMF.
A Mirtazapine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mirtazapine 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 Mirtazapine suppliers with CEP (COS) on PharmaCompass.
A Mirtazapine written confirmation (Mirtazapine WC) is an official document issued by a regulatory agency to a Mirtazapine manufacturer, verifying that the manufacturing facility of a Mirtazapine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mirtazapine APIs or Mirtazapine finished pharmaceutical products to another nation, regulatory agencies frequently require a Mirtazapine WC (written confirmation) as part of the regulatory process.
click here to find a list of Mirtazapine 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 Mirtazapine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mirtazapine 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 Mirtazapine 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 Mirtazapine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mirtazapine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mirtazapine suppliers with NDC on PharmaCompass.
Mirtazapine 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 Mirtazapine 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 Mirtazapine GMP manufacturer or Mirtazapine GMP API supplier for your needs.
A Mirtazapine CoA (Certificate of Analysis) is a formal document that attests to Mirtazapine's compliance with Mirtazapine specifications and serves as a tool for batch-level quality control.
Mirtazapine CoA mostly includes findings from lab analyses of a specific batch. For each Mirtazapine 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.
Mirtazapine may be tested according to a variety of international standards, such as European Pharmacopoeia (Mirtazapine EP), Mirtazapine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mirtazapine USP).
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