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Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
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A Dacomitinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dacomitinib, including repackagers and relabelers. The FDA regulates Dacomitinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dacomitinib 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 Dacomitinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dacomitinib supplier is an individual or a company that provides Dacomitinib active pharmaceutical ingredient (API) or Dacomitinib finished formulations upon request. The Dacomitinib suppliers may include Dacomitinib API manufacturers, exporters, distributors and traders.
click here to find a list of Dacomitinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dacomitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Dacomitinib active pharmaceutical ingredient (API) in detail. Different forms of Dacomitinib DMFs exist exist since differing nations have different regulations, such as Dacomitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dacomitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Dacomitinib USDMF includes data on Dacomitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dacomitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dacomitinib suppliers with USDMF 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 Dacomitinib Drug Master File in Korea (Dacomitinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dacomitinib. The MFDS reviews the Dacomitinib KDMF as part of the drug registration process and uses the information provided in the Dacomitinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dacomitinib 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 Dacomitinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dacomitinib suppliers with KDMF on PharmaCompass.
A Dacomitinib written confirmation (Dacomitinib WC) is an official document issued by a regulatory agency to a Dacomitinib manufacturer, verifying that the manufacturing facility of a Dacomitinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dacomitinib APIs or Dacomitinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Dacomitinib WC (written confirmation) as part of the regulatory process.
click here to find a list of Dacomitinib 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 Dacomitinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dacomitinib 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 Dacomitinib 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 Dacomitinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dacomitinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dacomitinib suppliers with NDC on PharmaCompass.
Dacomitinib 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 Dacomitinib 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 Dacomitinib GMP manufacturer or Dacomitinib GMP API supplier for your needs.
A Dacomitinib CoA (Certificate of Analysis) is a formal document that attests to Dacomitinib's compliance with Dacomitinib specifications and serves as a tool for batch-level quality control.
Dacomitinib CoA mostly includes findings from lab analyses of a specific batch. For each Dacomitinib 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.
Dacomitinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Dacomitinib EP), Dacomitinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dacomitinib USP).
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