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Looking for 1421373-66-1 / Osimertinib Mesylate API manufacturers, exporters & distributors?

Osimertinib Mesylate manufacturers, exporters & distributors 1

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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.

API | Excipient name

Osimertinib Mesylate

Synonyms

1421373-66-1, Azd-9291 mesylate, Azd9291 mesylate, Azd-9291 (mesylate), Mereletinib mesylate, Tagrisso

Cas Number

1421373-66-1

Unique Ingredient Identifier (UNII)

RDL94R2A16

About Osimertinib Mesylate

Osimertinib Mesylate is the mesylate salt form of osimertinib, a third-generation, orally available, irreversible, mutant-selective, epidermal growth factor receptor (EGFR) inhibitor, with potential antineoplastic activity. Upon oral administration, osimertinib covalently binds to and inhibits the activity of numerous mutant forms of EGFR, including the secondarily-acquired resistance mutation T790M, L858R, and exon 19 deletions, thereby preventing EGFR-mediated signaling. This may both induce cell death and inhibit tumor growth in EGFR-overexpressing tumor cells. EGFR, a receptor tyrosine kinase mutated in many tumor cell types, plays a key role in tumor cell proliferation and tumor vascularization. As this agent is selective towards mutant forms of EGFR, its toxicity profile may be reduced when compared to non-selective EGFR inhibitors which also inhibit wild-type EGFR.

Osimertinib Manufacturers

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.

Osimertinib Suppliers

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.

Osimertinib USDMF

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.

Osimertinib KDMF

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.

Osimertinib WC

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.

Osimertinib NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Osimertinib API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Osimertinib CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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