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