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USDMF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34836
Submission : 2021-02-05
Status :
Type : II
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-03
Pay. Date : 2018-01-24
DMF Number : 32266
Submission : 2018-01-17
Status :
Type : II
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ABOUT THIS PAGE
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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.
A Lapatinib ditosylate anhydrous manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lapatinib ditosylate anhydrous, including repackagers and relabelers. The FDA regulates Lapatinib ditosylate anhydrous manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lapatinib ditosylate anhydrous 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 anhydrous manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lapatinib ditosylate anhydrous supplier is an individual or a company that provides Lapatinib ditosylate anhydrous active pharmaceutical ingredient (API) or Lapatinib ditosylate anhydrous finished formulations upon request. The Lapatinib ditosylate anhydrous suppliers may include Lapatinib ditosylate anhydrous API manufacturers, exporters, distributors and traders.
click here to find a list of Lapatinib ditosylate anhydrous suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lapatinib ditosylate anhydrous DMF (Drug Master File) is a document detailing the whole manufacturing process of Lapatinib ditosylate anhydrous active pharmaceutical ingredient (API) in detail. Different forms of Lapatinib ditosylate anhydrous DMFs exist exist since differing nations have different regulations, such as Lapatinib ditosylate anhydrous USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lapatinib ditosylate anhydrous DMF submitted to regulatory agencies in the US is known as a USDMF. Lapatinib ditosylate anhydrous USDMF includes data on Lapatinib ditosylate anhydrous's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lapatinib ditosylate anhydrous USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lapatinib ditosylate anhydrous suppliers with USDMF on PharmaCompass.
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 anhydrous Drug Master File in Japan (Lapatinib ditosylate anhydrous JDMF) empowers Lapatinib ditosylate anhydrous 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 anhydrous JDMF during the approval evaluation for pharmaceutical products. At the time of Lapatinib ditosylate anhydrous 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 anhydrous suppliers with JDMF on PharmaCompass.
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 anhydrous Drug Master File in Korea (Lapatinib ditosylate anhydrous KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lapatinib ditosylate anhydrous. The MFDS reviews the Lapatinib ditosylate anhydrous KDMF as part of the drug registration process and uses the information provided in the Lapatinib ditosylate anhydrous KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lapatinib ditosylate anhydrous 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 anhydrous API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lapatinib ditosylate anhydrous suppliers with KDMF on PharmaCompass.
A Lapatinib ditosylate anhydrous written confirmation (Lapatinib ditosylate anhydrous WC) is an official document issued by a regulatory agency to a Lapatinib ditosylate anhydrous manufacturer, verifying that the manufacturing facility of a Lapatinib ditosylate anhydrous active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lapatinib ditosylate anhydrous APIs or Lapatinib ditosylate anhydrous finished pharmaceutical products to another nation, regulatory agencies frequently require a Lapatinib ditosylate anhydrous WC (written confirmation) as part of the regulatory process.
click here to find a list of Lapatinib ditosylate anhydrous suppliers with Written Confirmation (WC) on PharmaCompass.
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 anhydrous as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lapatinib ditosylate anhydrous API and other APIs are published in this directory by the FDA.
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 anhydrous 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.
The NDC directory also contains data on finished compounded human drug products that contain Lapatinib ditosylate anhydrous and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lapatinib ditosylate anhydrous NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lapatinib ditosylate anhydrous suppliers with NDC on PharmaCompass.
Lapatinib ditosylate anhydrous 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 anhydrous 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 anhydrous GMP manufacturer or Lapatinib ditosylate anhydrous GMP API supplier for your needs.
A Lapatinib ditosylate anhydrous CoA (Certificate of Analysis) is a formal document that attests to Lapatinib ditosylate anhydrous's compliance with Lapatinib ditosylate anhydrous specifications and serves as a tool for batch-level quality control.
Lapatinib ditosylate anhydrous CoA mostly includes findings from lab analyses of a specific batch. For each Lapatinib ditosylate anhydrous 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 anhydrous may be tested according to a variety of international standards, such as European Pharmacopoeia (Lapatinib ditosylate anhydrous EP), Lapatinib ditosylate anhydrous JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lapatinib ditosylate anhydrous USP).
