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