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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...
With Fermion, start the journey of your innovative API.
About the Company : Fermion is fully owned subsidiary of Orion Corporation & headquartered in Espoo, Finland. Together with Orion we are a fully integrated CDMO & offer services covering both APIs & F...
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Tablet
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Tablet
Dosage Strength : 80MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
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NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
Regulatory Info :
Registration Country : Iran
Brand Name : Mertisso
Dosage Form : Film Coated Tablet
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
Regulatory Info :
Registration Country : Iran
Brand Name : Mertisso
Dosage Form : Film Coated Tablet
Dosage Strength : 80MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
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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).
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