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List of Drug Master Files (KDMF) for Lapatinib Ditosylate Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Thermo Fisher Scientific Cork Limited (1)

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01 Novartis Korea Co., Ltd. (1)

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01 lapatinib ditosylate (1)

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01 U.S.A (1)

URL Supplier Web Content
Novartis Korea Co., Ltd.
2007-07-24
89-3-ND
Thermo Fisher Scientific ...
Ireland
Currabinny, Carrigaline, ...
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Looking for 388082-77-7 / Lapatinib Ditosylate API manufacturers, exporters & distributors?

Lapatinib Ditosylate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Lapatinib Ditosylate

Synonyms

388082-77-7, Tykerb, Tykerb ditosylate, Lapatinib (gw-572016) ditosylate, Tyverb, Lapatinib (ditosylate)

Cas Number

388082-77-7

Unique Ingredient Identifier (UNII)

4WK72K94MC

About Lapatinib Ditosylate

A quinazoline derivative that inhibits EPIDERMAL GROWTH FACTOR RECEPTOR and HER2 (RECEPTOR, ERBB-2) tyrosine kinases. It is used for the treatment of advanced or metastatic breast cancer, where tumors overexpress HER2.

Lapatinib Ditosylate Manufacturers

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

Lapatinib Ditosylate Suppliers

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

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

Lapatinib Ditosylate KDMF

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

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

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

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

Lapatinib Ditosylate Manufacturers | Traders | Suppliers

Lapatinib Ditosylate Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Lapatinib Ditosylate

Get in contact with the supplier of your choice:

  1. Thermo Fisher Scientific
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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