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Looking for 1661854-97-2 / CLN-081 API manufacturers, exporters & distributors?

CLN-081 manufacturers, exporters & distributors 1

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PharmaCompass offers a list of CLN-081 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 CLN-081 manufacturer or CLN-081 supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred CLN-081 manufacturer or CLN-081 supplier.

PharmaCompass also assists you with knowing the CLN-081 API Price utilized in the formulation of products. CLN-081 API Price is not always fixed or binding as the CLN-081 Price is obtained through a variety of data sources. The CLN-081 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

CLN-081

Synonyms

Tas6417, 1661854-97-2, Zipalertinib, Tas-6417, Zipalertinib [inn], T4ymu8tw9h

Cas Number

1661854-97-2

Unique Ingredient Identifier (UNII)

T4YMU8TW9H

About CLN-081

Zipalertinib is an orally available selective inhibitor of a broad spectrum of epidermal growth factor receptor (EGFR) mutations, including EGFR exon 20 insertion mutations (EGFR Ex20ins; Ex20ins mutations), with potential antineoplastic activity. CLN-081 is also active against other EGFR mutations including exon 19 deletions (exon19del), L858R, and T790M, as well as the less common G719X, L861Q and S768I mutations. Upon administration, zipalertinib specifically and covalently binds to and inhibits a variety of EGFR mutations, with particularly high selectivity against EGFR Ex20ins, which prevents EGFR mutant-mediated signaling and leads to cell death in EGFR mutant-expressing tumor cells. Compared to some other EGFR inhibitors, CLN-081 may have therapeutic benefits in tumors with EGFR Ex20ins, as most EGFR mutant-selective inhibitors are not active against EGFR Ex20ins. This agent shows minimal activity against wild-type EGFR (wt EGFR), and does not cause dose-limiting toxicities that occur during the use of non-selective EGFR inhibitors, which also inhibit wt EGFR. EGFR, a receptor tyrosine kinase mutated in many tumor cell types, plays a key role in tumor cell proliferation and tumor vascularization.

CLN-081 Manufacturers

A CLN-081 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CLN-081, including repackagers and relabelers. The FDA regulates CLN-081 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CLN-081 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 CLN-081 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

CLN-081 Suppliers

A CLN-081 supplier is an individual or a company that provides CLN-081 active pharmaceutical ingredient (API) or CLN-081 finished formulations upon request. The CLN-081 suppliers may include CLN-081 API manufacturers, exporters, distributors and traders.

click here to find a list of CLN-081 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

CLN-081 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 CLN-081 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for CLN-081 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 CLN-081 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 CLN-081 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CLN-081 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of CLN-081 suppliers with NDC on PharmaCompass.

CLN-081 GMP

CLN-081 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 CLN-081 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 CLN-081 GMP manufacturer or CLN-081 GMP API supplier for your needs.

CLN-081 CoA

A CLN-081 CoA (Certificate of Analysis) is a formal document that attests to CLN-081's compliance with CLN-081 specifications and serves as a tool for batch-level quality control.

CLN-081 CoA mostly includes findings from lab analyses of a specific batch. For each CLN-081 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.

CLN-081 may be tested according to a variety of international standards, such as European Pharmacopoeia (CLN-081 EP), CLN-081 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CLN-081 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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