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