Lazertinib

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

1 KDMF

1 KDMF

DEVELOPMENTS

13 Drug(s) in Development

13 Drug(s) in Development

PRICE INFORMATION

API Reference Price, API Imports

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Yuhan Corporation

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South Korea

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Lazertinib

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Registrant Name

Yuhan Chemical Co., Ltd.

Registration Date

2021-01-18

Registration Number

1791-9-ND

Manufacturer

Yuhan Chemical Co., Ltd.

Manufacturer’s Country

South Korea

Manufacturer’s Address

Room 402, 5-ba, Sihwa Ind...

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Looking for 1903008-80-9 / Lazertinib API manufacturers, exporters & distributors?

PharmaCompass offers a list of Lazertinib 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 Lazertinib manufacturer or Lazertinib supplier for your needs.

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

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

API | Excipient name

Lazertinib

Synonyms

1903008-80-9, Yh-25448, Gns-1480, Yh25448, Gns1480, Jnj-73841937-aaa

Cas Number

1903008-80-9

Unique Ingredient Identifier (UNII)

4A2Y23XK11

About Lazertinib

Lazertinib is an orally available third-generation, selective inhibitor of certain forms of the epidermal growth factor receptor (EGFR) with activating mutations, including the resistance mutation T790M, exon 19 deletions (Del19), and the L858R mutation, with potential antineoplastic activity. Upon administration, lazertinib specifically and irreversibly binds to and inhibits selective EGFR mutants, which prevents EGFR mutant-mediated signaling and leads to cell death in EGFR mutant-expressing tumor cells. Lazertinib may inhibit programmed cell death-1 ligand 1 (PD-L1) and inflammatory cytokines in specific cancer cells harboring certain EGFR mutations. Compared to some other EGFR inhibitors, lazertinib may have therapeutic benefits in tumors with T790M- or L858R-mediated drug resistance. In addition, lazertinib penetrates the blood-brain barrier (BBB). This agent shows minimal activity against wild-type EGFR (wtEGFR), and does not cause dose-limiting toxicities, which occur during the use of non-selective EGFR inhibitors and inhibit wtEGFR. EGFR, a receptor tyrosine kinase (RTK) mutated in many tumor cell types, plays a key role in tumor cell proliferation and tumor vascularization.

Lazertinib Manufacturers

A Lazertinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lazertinib, including repackagers and relabelers. The FDA regulates Lazertinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lazertinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Lazertinib Suppliers

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

Lazertinib KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Lazertinib Drug Master File in Korea (Lazertinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lazertinib. The MFDS reviews the Lazertinib KDMF as part of the drug registration process and uses the information provided in the Lazertinib KDMF to evaluate the safety and efficacy of the drug.

After submitting a Lazertinib 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 Lazertinib API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Lazertinib suppliers with KDMF on PharmaCompass.

Lazertinib Manufacturers | Traders | Suppliers

We have 1 companies offering Lazertinib

Get in contact with the supplier of your choice:

Yuhan Corporation

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.