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