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