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Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
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DOSAGE - TABLET;ORAL - 120MG
USFDA APPLICATION NUMBER - 19865
DOSAGE - TABLET;ORAL - 160MG
USFDA APPLICATION NUMBER - 19865
DOSAGE - TABLET;ORAL - 240MG
USFDA APPLICATION NUMBER - 19865
DOSAGE - TABLET;ORAL - 80MG
USFDA APPLICATION NUMBER - 19865
DOSAGE - TABLET;ORAL - 120MG
USFDA APPLICATION NUMBER - 21151
DOSAGE - TABLET;ORAL - 160MG
USFDA APPLICATION NUMBER - 21151
DOSAGE - TABLET;ORAL - 80MG
USFDA APPLICATION NUMBER - 21151
DOSAGE - SOLUTION;INTRAVENOUS - 150MG/10ML (1...DOSAGE - SOLUTION;INTRAVENOUS - 150MG/10ML (15MG/ML)
USFDA APPLICATION NUMBER - 22306
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ABOUT THIS PAGE
21
PharmaCompass offers a list of Sotalol 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 Sotalol Hydrochloride manufacturer or Sotalol Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sotalol Hydrochloride manufacturer or Sotalol Hydrochloride supplier.
PharmaCompass also assists you with knowing the Sotalol Hydrochloride API Price utilized in the formulation of products. Sotalol Hydrochloride API Price is not always fixed or binding as the Sotalol Hydrochloride Price is obtained through a variety of data sources. The Sotalol Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sotalol Monohydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sotalol Monohydrochloride, including repackagers and relabelers. The FDA regulates Sotalol Monohydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sotalol Monohydrochloride 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 Monohydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sotalol Monohydrochloride supplier is an individual or a company that provides Sotalol Monohydrochloride active pharmaceutical ingredient (API) or Sotalol Monohydrochloride finished formulations upon request. The Sotalol Monohydrochloride suppliers may include Sotalol Monohydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sotalol Monohydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sotalol Monohydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sotalol Monohydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Sotalol Monohydrochloride DMFs exist exist since differing nations have different regulations, such as Sotalol Monohydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sotalol Monohydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Sotalol Monohydrochloride USDMF includes data on Sotalol Monohydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sotalol Monohydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sotalol Monohydrochloride 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 Monohydrochloride Drug Master File in Japan (Sotalol Monohydrochloride JDMF) empowers Sotalol Monohydrochloride 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 Monohydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Sotalol Monohydrochloride 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 Monohydrochloride suppliers with JDMF on PharmaCompass.
A Sotalol Monohydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Sotalol Monohydrochloride Certificate of Suitability (COS). The purpose of a Sotalol Monohydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sotalol Monohydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sotalol Monohydrochloride to their clients by showing that a Sotalol Monohydrochloride CEP has been issued for it. The manufacturer submits a Sotalol Monohydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sotalol Monohydrochloride CEP holder for the record. Additionally, the data presented in the Sotalol Monohydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sotalol Monohydrochloride DMF.
A Sotalol Monohydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sotalol Monohydrochloride 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 Monohydrochloride suppliers with CEP (COS) on PharmaCompass.
A Sotalol Monohydrochloride written confirmation (Sotalol Monohydrochloride WC) is an official document issued by a regulatory agency to a Sotalol Monohydrochloride manufacturer, verifying that the manufacturing facility of a Sotalol Monohydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sotalol Monohydrochloride APIs or Sotalol Monohydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Sotalol Monohydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Sotalol Monohydrochloride 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 Monohydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sotalol Monohydrochloride 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 Monohydrochloride 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 Monohydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sotalol Monohydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sotalol Monohydrochloride suppliers with NDC on PharmaCompass.
Sotalol Monohydrochloride 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 Monohydrochloride 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 Monohydrochloride GMP manufacturer or Sotalol Monohydrochloride GMP API supplier for your needs.
A Sotalol Monohydrochloride CoA (Certificate of Analysis) is a formal document that attests to Sotalol Monohydrochloride's compliance with Sotalol Monohydrochloride specifications and serves as a tool for batch-level quality control.
Sotalol Monohydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Sotalol Monohydrochloride 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 Monohydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Sotalol Monohydrochloride EP), Sotalol Monohydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sotalol Monohydrochloride USP).
