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