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