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