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