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