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