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**Feder...DOSAGE - CAPSULE;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federa...DOSAGE - CAPSULE;ORAL - EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federa...DOSAGE - CAPSULE;ORAL - EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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