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API SUPPLIERS
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USDMF
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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20254
DOSAGE - SOLUTION;TOPICAL - 2% **Federal Regi...DOSAGE - SOLUTION;TOPICAL - 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 204623
DOSAGE - TABLET, DELAYED RELEASE;ORAL - 50MG;...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 50MG;0.2MG
USFDA APPLICATION NUMBER - 20607
DOSAGE - TABLET, DELAYED RELEASE;ORAL - 75MG;...DOSAGE - TABLET, DELAYED RELEASE;ORAL - 75MG;0.2MG
USFDA APPLICATION NUMBER - 20607
DOSAGE - SOLUTION;TOPICAL - 1.5% **Federal Re...DOSAGE - SOLUTION;TOPICAL - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20947
DOSAGE - GEL;TOPICAL - 3% **Federal Register ...DOSAGE - GEL;TOPICAL - 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21005
DOSAGE - GEL;TOPICAL - 1%
USFDA APPLICATION NUMBER - 22122
DOSAGE - SOLUTION;INTRAVENOUS - 37.5MG/ML (37...DOSAGE - SOLUTION;INTRAVENOUS - 37.5MG/ML (37.5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22396
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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 Diclophenac sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diclophenac sodium, including repackagers and relabelers. The FDA regulates Diclophenac sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diclophenac 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 Diclophenac sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Diclophenac sodium supplier is an individual or a company that provides Diclophenac sodium active pharmaceutical ingredient (API) or Diclophenac sodium finished formulations upon request. The Diclophenac sodium suppliers may include Diclophenac sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Diclophenac sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Diclophenac sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Diclophenac sodium active pharmaceutical ingredient (API) in detail. Different forms of Diclophenac sodium DMFs exist exist since differing nations have different regulations, such as Diclophenac sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Diclophenac sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Diclophenac sodium USDMF includes data on Diclophenac sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Diclophenac sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Diclophenac 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 Diclophenac sodium Drug Master File in Japan (Diclophenac sodium JDMF) empowers Diclophenac 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 Diclophenac sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Diclophenac 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 Diclophenac 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 Diclophenac sodium Drug Master File in Korea (Diclophenac sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Diclophenac sodium. The MFDS reviews the Diclophenac sodium KDMF as part of the drug registration process and uses the information provided in the Diclophenac sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Diclophenac 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 Diclophenac sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Diclophenac sodium suppliers with KDMF on PharmaCompass.
A Diclophenac sodium CEP of the European Pharmacopoeia monograph is often referred to as a Diclophenac sodium Certificate of Suitability (COS). The purpose of a Diclophenac sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Diclophenac sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Diclophenac sodium to their clients by showing that a Diclophenac sodium CEP has been issued for it. The manufacturer submits a Diclophenac sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Diclophenac sodium CEP holder for the record. Additionally, the data presented in the Diclophenac sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Diclophenac sodium DMF.
A Diclophenac sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Diclophenac 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 Diclophenac sodium suppliers with CEP (COS) on PharmaCompass.
A Diclophenac sodium written confirmation (Diclophenac sodium WC) is an official document issued by a regulatory agency to a Diclophenac sodium manufacturer, verifying that the manufacturing facility of a Diclophenac sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Diclophenac sodium APIs or Diclophenac sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Diclophenac sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Diclophenac 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 Diclophenac sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Diclophenac 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 Diclophenac 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 Diclophenac sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Diclophenac sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Diclophenac sodium suppliers with NDC on PharmaCompass.
Diclophenac 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 Diclophenac 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 Diclophenac sodium GMP manufacturer or Diclophenac sodium GMP API supplier for your needs.
A Diclophenac sodium CoA (Certificate of Analysis) is a formal document that attests to Diclophenac sodium's compliance with Diclophenac sodium specifications and serves as a tool for batch-level quality control.
Diclophenac sodium CoA mostly includes findings from lab analyses of a specific batch. For each Diclophenac 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.
Diclophenac sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Diclophenac sodium EP), Diclophenac sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Diclophenac sodium USP).
