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