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