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PharmaCompass offers a list of Dapoxetine 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 Dapoxetine Hydrochloride manufacturer or Dapoxetine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dapoxetine Hydrochloride manufacturer or Dapoxetine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Dapoxetine Hydrochloride API Price utilized in the formulation of products. Dapoxetine Hydrochloride API Price is not always fixed or binding as the Dapoxetine Hydrochloride Price is obtained through a variety of data sources. The Dapoxetine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dapoxetine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dapoxetine, including repackagers and relabelers. The FDA regulates Dapoxetine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dapoxetine 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 Dapoxetine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dapoxetine supplier is an individual or a company that provides Dapoxetine active pharmaceutical ingredient (API) or Dapoxetine finished formulations upon request. The Dapoxetine suppliers may include Dapoxetine API manufacturers, exporters, distributors and traders.
click here to find a list of Dapoxetine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dapoxetine DMF (Drug Master File) is a document detailing the whole manufacturing process of Dapoxetine active pharmaceutical ingredient (API) in detail. Different forms of Dapoxetine DMFs exist exist since differing nations have different regulations, such as Dapoxetine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dapoxetine DMF submitted to regulatory agencies in the US is known as a USDMF. Dapoxetine USDMF includes data on Dapoxetine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dapoxetine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dapoxetine suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Dapoxetine Drug Master File in Korea (Dapoxetine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dapoxetine. The MFDS reviews the Dapoxetine KDMF as part of the drug registration process and uses the information provided in the Dapoxetine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dapoxetine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dapoxetine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dapoxetine suppliers with KDMF on PharmaCompass.
A Dapoxetine written confirmation (Dapoxetine WC) is an official document issued by a regulatory agency to a Dapoxetine manufacturer, verifying that the manufacturing facility of a Dapoxetine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dapoxetine APIs or Dapoxetine finished pharmaceutical products to another nation, regulatory agencies frequently require a Dapoxetine WC (written confirmation) as part of the regulatory process.
click here to find a list of Dapoxetine 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 Dapoxetine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dapoxetine 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 Dapoxetine 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 Dapoxetine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dapoxetine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dapoxetine suppliers with NDC on PharmaCompass.
Dapoxetine 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 Dapoxetine 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 Dapoxetine GMP manufacturer or Dapoxetine GMP API supplier for your needs.
A Dapoxetine CoA (Certificate of Analysis) is a formal document that attests to Dapoxetine's compliance with Dapoxetine specifications and serves as a tool for batch-level quality control.
Dapoxetine CoA mostly includes findings from lab analyses of a specific batch. For each Dapoxetine 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.
Dapoxetine may be tested according to a variety of international standards, such as European Pharmacopoeia (Dapoxetine EP), Dapoxetine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dapoxetine USP).
