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API SUPPLIERS
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USDMF
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DOSAGE - CREAM;TOPICAL - 1%
USFDA APPLICATION NUMBER - 17381
DOSAGE - CREAM;TOPICAL - 1%
USFDA APPLICATION NUMBER - 18578
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Nanjing Well Pharmaceutical
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PharmaCompass offers a list of Silver Sulfadiazine 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 Silver Sulfadiazine manufacturer or Silver Sulfadiazine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Silver Sulfadiazine manufacturer or Silver Sulfadiazine supplier.
PharmaCompass also assists you with knowing the Silver Sulfadiazine API Price utilized in the formulation of products. Silver Sulfadiazine API Price is not always fixed or binding as the Silver Sulfadiazine Price is obtained through a variety of data sources. The Silver Sulfadiazine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Silver Sulfadiazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Silver Sulfadiazine, including repackagers and relabelers. The FDA regulates Silver Sulfadiazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Silver Sulfadiazine 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 Silver Sulfadiazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Silver Sulfadiazine supplier is an individual or a company that provides Silver Sulfadiazine active pharmaceutical ingredient (API) or Silver Sulfadiazine finished formulations upon request. The Silver Sulfadiazine suppliers may include Silver Sulfadiazine API manufacturers, exporters, distributors and traders.
click here to find a list of Silver Sulfadiazine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Silver Sulfadiazine DMF (Drug Master File) is a document detailing the whole manufacturing process of Silver Sulfadiazine active pharmaceutical ingredient (API) in detail. Different forms of Silver Sulfadiazine DMFs exist exist since differing nations have different regulations, such as Silver Sulfadiazine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Silver Sulfadiazine DMF submitted to regulatory agencies in the US is known as a USDMF. Silver Sulfadiazine USDMF includes data on Silver Sulfadiazine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Silver Sulfadiazine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Silver Sulfadiazine 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 Silver Sulfadiazine Drug Master File in Japan (Silver Sulfadiazine JDMF) empowers Silver Sulfadiazine 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 Silver Sulfadiazine JDMF during the approval evaluation for pharmaceutical products. At the time of Silver Sulfadiazine 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 Silver Sulfadiazine suppliers with JDMF on PharmaCompass.
A Silver Sulfadiazine written confirmation (Silver Sulfadiazine WC) is an official document issued by a regulatory agency to a Silver Sulfadiazine manufacturer, verifying that the manufacturing facility of a Silver Sulfadiazine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Silver Sulfadiazine APIs or Silver Sulfadiazine finished pharmaceutical products to another nation, regulatory agencies frequently require a Silver Sulfadiazine WC (written confirmation) as part of the regulatory process.
click here to find a list of Silver Sulfadiazine 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 Silver Sulfadiazine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Silver Sulfadiazine 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 Silver Sulfadiazine 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 Silver Sulfadiazine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Silver Sulfadiazine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Silver Sulfadiazine suppliers with NDC on PharmaCompass.
Silver Sulfadiazine 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 Silver Sulfadiazine 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 Silver Sulfadiazine GMP manufacturer or Silver Sulfadiazine GMP API supplier for your needs.
A Silver Sulfadiazine CoA (Certificate of Analysis) is a formal document that attests to Silver Sulfadiazine's compliance with Silver Sulfadiazine specifications and serves as a tool for batch-level quality control.
Silver Sulfadiazine CoA mostly includes findings from lab analyses of a specific batch. For each Silver Sulfadiazine 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.
Silver Sulfadiazine may be tested according to a variety of international standards, such as European Pharmacopoeia (Silver Sulfadiazine EP), Silver Sulfadiazine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Silver Sulfadiazine USP).
