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