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