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