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