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API SUPPLIERS
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35231
Submission : 2020-09-28
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-26
Pay. Date : 2020-09-21
DMF Number : 34665
Submission : 2020-03-31
Status :
Type : II
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 : 36640
Submission : 2021-12-29
Status :
Type : II
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ABOUT THIS PAGE
A Midostaurin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Midostaurin, including repackagers and relabelers. The FDA regulates Midostaurin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Midostaurin 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 Midostaurin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Midostaurin supplier is an individual or a company that provides Midostaurin active pharmaceutical ingredient (API) or Midostaurin finished formulations upon request. The Midostaurin suppliers may include Midostaurin API manufacturers, exporters, distributors and traders.
click here to find a list of Midostaurin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Midostaurin DMF (Drug Master File) is a document detailing the whole manufacturing process of Midostaurin active pharmaceutical ingredient (API) in detail. Different forms of Midostaurin DMFs exist exist since differing nations have different regulations, such as Midostaurin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Midostaurin DMF submitted to regulatory agencies in the US is known as a USDMF. Midostaurin USDMF includes data on Midostaurin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Midostaurin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Midostaurin suppliers with USDMF on PharmaCompass.
A Midostaurin written confirmation (Midostaurin WC) is an official document issued by a regulatory agency to a Midostaurin manufacturer, verifying that the manufacturing facility of a Midostaurin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Midostaurin APIs or Midostaurin finished pharmaceutical products to another nation, regulatory agencies frequently require a Midostaurin WC (written confirmation) as part of the regulatory process.
click here to find a list of Midostaurin 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 Midostaurin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Midostaurin 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 Midostaurin 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 Midostaurin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Midostaurin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Midostaurin suppliers with NDC on PharmaCompass.
Midostaurin 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 Midostaurin 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 Midostaurin GMP manufacturer or Midostaurin GMP API supplier for your needs.
A Midostaurin CoA (Certificate of Analysis) is a formal document that attests to Midostaurin's compliance with Midostaurin specifications and serves as a tool for batch-level quality control.
Midostaurin CoA mostly includes findings from lab analyses of a specific batch. For each Midostaurin 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.
Midostaurin may be tested according to a variety of international standards, such as European Pharmacopoeia (Midostaurin EP), Midostaurin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Midostaurin USP).
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