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