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