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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 USDMF

A Lapatinib Ditosylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Lapatinib Ditosylate active pharmaceutical ingredient (API) in detail. Different forms of Lapatinib Ditosylate DMFs exist exist since differing nations have different regulations, such as Lapatinib Ditosylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Lapatinib Ditosylate DMF submitted to regulatory agencies in the US is known as a USDMF. Lapatinib Ditosylate USDMF includes data on Lapatinib Ditosylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lapatinib Ditosylate USDMF is kept confidential to protect the manufacturer’s intellectual property.

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

Lapatinib Ditosylate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Lapatinib Ditosylate Drug Master File in Japan (Lapatinib Ditosylate JDMF) empowers Lapatinib Ditosylate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Lapatinib Ditosylate JDMF during the approval evaluation for pharmaceutical products. At the time of Lapatinib Ditosylate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Lapatinib Ditosylate suppliers with JDMF 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 WC

A Lapatinib Ditosylate written confirmation (Lapatinib Ditosylate WC) is an official document issued by a regulatory agency to a Lapatinib Ditosylate manufacturer, verifying that the manufacturing facility of a Lapatinib Ditosylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lapatinib Ditosylate APIs or Lapatinib Ditosylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Lapatinib Ditosylate WC (written confirmation) as part of the regulatory process.

click here to find a list of Lapatinib Ditosylate suppliers with Written Confirmation (WC) on PharmaCompass.

Lapatinib Ditosylate 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 Lapatinib Ditosylate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Lapatinib Ditosylate GMP

Lapatinib Ditosylate 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 Lapatinib Ditosylate 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 Lapatinib Ditosylate GMP manufacturer or Lapatinib Ditosylate GMP API supplier for your needs.

Lapatinib Ditosylate CoA

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

Lapatinib Ditosylate CoA mostly includes findings from lab analyses of a specific batch. For each Lapatinib Ditosylate 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.

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