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API SUPPLIERS
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USDMF
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41492
Submission : 2025-03-31
Status :
Type : II
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Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Selumetinib 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 Selumetinib manufacturer or Selumetinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Selumetinib manufacturer or Selumetinib supplier.
PharmaCompass also assists you with knowing the Selumetinib API Price utilized in the formulation of products. Selumetinib API Price is not always fixed or binding as the Selumetinib Price is obtained through a variety of data sources. The Selumetinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Selumetinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Selumetinib, including repackagers and relabelers. The FDA regulates Selumetinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Selumetinib 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 Selumetinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Selumetinib supplier is an individual or a company that provides Selumetinib active pharmaceutical ingredient (API) or Selumetinib finished formulations upon request. The Selumetinib suppliers may include Selumetinib API manufacturers, exporters, distributors and traders.
click here to find a list of Selumetinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Selumetinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Selumetinib active pharmaceutical ingredient (API) in detail. Different forms of Selumetinib DMFs exist exist since differing nations have different regulations, such as Selumetinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Selumetinib DMF submitted to regulatory agencies in the US is known as a USDMF. Selumetinib USDMF includes data on Selumetinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Selumetinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Selumetinib suppliers with USDMF 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 Selumetinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Selumetinib 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 Selumetinib 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 Selumetinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Selumetinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Selumetinib suppliers with NDC on PharmaCompass.
Selumetinib 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 Selumetinib 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 Selumetinib GMP manufacturer or Selumetinib GMP API supplier for your needs.
A Selumetinib CoA (Certificate of Analysis) is a formal document that attests to Selumetinib's compliance with Selumetinib specifications and serves as a tool for batch-level quality control.
Selumetinib CoA mostly includes findings from lab analyses of a specific batch. For each Selumetinib 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.
Selumetinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Selumetinib EP), Selumetinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Selumetinib USP).
