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