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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - CAPSULE;ORAL - EQ 100MG BASE **Feder...DOSAGE - CAPSULE;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 16792
DOSAGE - CAPSULE;ORAL - EQ 25MG BASE **Federa...DOSAGE - CAPSULE;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 16792
DOSAGE - CAPSULE;ORAL - EQ 50MG BASE **Federa...DOSAGE - CAPSULE;ORAL - EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 16792
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Trimipramine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trimipramine Maleate, including repackagers and relabelers. The FDA regulates Trimipramine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trimipramine Maleate 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 Trimipramine Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trimipramine Maleate supplier is an individual or a company that provides Trimipramine Maleate active pharmaceutical ingredient (API) or Trimipramine Maleate finished formulations upon request. The Trimipramine Maleate suppliers may include Trimipramine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Trimipramine Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trimipramine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Trimipramine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Trimipramine Maleate DMFs exist exist since differing nations have different regulations, such as Trimipramine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trimipramine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Trimipramine Maleate USDMF includes data on Trimipramine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trimipramine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Trimipramine Maleate 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 Trimipramine Maleate Drug Master File in Japan (Trimipramine Maleate JDMF) empowers Trimipramine Maleate 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 Trimipramine Maleate JDMF during the approval evaluation for pharmaceutical products. At the time of Trimipramine Maleate 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 Trimipramine Maleate suppliers with JDMF on PharmaCompass.
A Trimipramine Maleate CEP of the European Pharmacopoeia monograph is often referred to as a Trimipramine Maleate Certificate of Suitability (COS). The purpose of a Trimipramine Maleate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Trimipramine Maleate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Trimipramine Maleate to their clients by showing that a Trimipramine Maleate CEP has been issued for it. The manufacturer submits a Trimipramine Maleate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Trimipramine Maleate CEP holder for the record. Additionally, the data presented in the Trimipramine Maleate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Trimipramine Maleate DMF.
A Trimipramine Maleate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Trimipramine Maleate 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 Trimipramine Maleate suppliers with CEP (COS) on PharmaCompass.
A Trimipramine Maleate written confirmation (Trimipramine Maleate WC) is an official document issued by a regulatory agency to a Trimipramine Maleate manufacturer, verifying that the manufacturing facility of a Trimipramine Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trimipramine Maleate APIs or Trimipramine Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Trimipramine Maleate WC (written confirmation) as part of the regulatory process.
click here to find a list of Trimipramine Maleate 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 Trimipramine Maleate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trimipramine Maleate 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 Trimipramine Maleate 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 Trimipramine Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trimipramine Maleate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trimipramine Maleate suppliers with NDC on PharmaCompass.
Trimipramine Maleate 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 Trimipramine Maleate 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 Trimipramine Maleate GMP manufacturer or Trimipramine Maleate GMP API supplier for your needs.
A Trimipramine Maleate CoA (Certificate of Analysis) is a formal document that attests to Trimipramine Maleate's compliance with Trimipramine Maleate specifications and serves as a tool for batch-level quality control.
Trimipramine Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Trimipramine Maleate 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.
Trimipramine Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Trimipramine Maleate EP), Trimipramine Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trimipramine Maleate USP).
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