Synopsis
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KDMF
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-22
Pay. Date : 2021-06-16
DMF Number : 13992
Submission : 1999-02-22
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-27
Pay. Date : 2014-06-23
DMF Number : 14951
Submission : 2000-07-13
Status :
Type : II
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Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Certificate Number : CEP 2002-049 - Rev 08
Status : Valid
Issue Date : 2024-03-12
Type : Chemical
Substance Number : 2004
Neuland Laboratories- A dedicated 100% API provider.
Certificate Number : CEP 2001-269 - Rev 09
Status : Valid
Issue Date : 2024-03-06
Type : Chemical
Substance Number : 2004
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Drugs in Development
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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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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
A Sotalol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sotalol Hydrochloride, including repackagers and relabelers. The FDA regulates Sotalol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sotalol Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sotalol Hydrochloride supplier is an individual or a company that provides Sotalol Hydrochloride active pharmaceutical ingredient (API) or Sotalol Hydrochloride finished formulations upon request. The Sotalol Hydrochloride suppliers may include Sotalol Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Sotalol Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sotalol Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Sotalol Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Sotalol Hydrochloride DMFs exist exist since differing nations have different regulations, such as Sotalol Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sotalol Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Sotalol Hydrochloride USDMF includes data on Sotalol Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sotalol Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sotalol Hydrochloride 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 Hydrochloride Drug Master File in Japan (Sotalol Hydrochloride JDMF) empowers Sotalol Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Sotalol Hydrochloride 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 Hydrochloride suppliers with JDMF on PharmaCompass.
A Sotalol Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Sotalol Hydrochloride Certificate of Suitability (COS). The purpose of a Sotalol Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sotalol Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sotalol Hydrochloride to their clients by showing that a Sotalol Hydrochloride CEP has been issued for it. The manufacturer submits a Sotalol Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sotalol Hydrochloride CEP holder for the record. Additionally, the data presented in the Sotalol Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sotalol Hydrochloride DMF.
A Sotalol Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sotalol Hydrochloride 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 Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Sotalol Hydrochloride written confirmation (Sotalol Hydrochloride WC) is an official document issued by a regulatory agency to a Sotalol Hydrochloride manufacturer, verifying that the manufacturing facility of a Sotalol Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sotalol Hydrochloride APIs or Sotalol Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Sotalol Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Sotalol Hydrochloride 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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sotalol Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sotalol Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sotalol Hydrochloride suppliers with NDC on PharmaCompass.
Sotalol Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Sotalol Hydrochloride GMP API supplier for your needs.
A Sotalol Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Sotalol Hydrochloride's compliance with Sotalol Hydrochloride specifications and serves as a tool for batch-level quality control.
Sotalol Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Sotalol Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Sotalol Hydrochloride EP), Sotalol Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sotalol Hydrochloride USP).
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