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API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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USDMF
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-06
Pay. Date : 2014-04-07
DMF Number : 26075
Submission : 2012-05-18
Status :
Type : II
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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
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DOSAGE - INJECTABLE;INJECTION - 1MG/ML **Fede...DOSAGE - INJECTABLE;INJECTION - 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21248
DOSAGE - INJECTABLE;INJECTION - 2MG/ML
USFDA APPLICATION NUMBER - 21248
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ABOUT THIS PAGE
A Arsenic Trioxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Arsenic Trioxide, including repackagers and relabelers. The FDA regulates Arsenic Trioxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Arsenic Trioxide 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 Arsenic Trioxide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Arsenic Trioxide supplier is an individual or a company that provides Arsenic Trioxide active pharmaceutical ingredient (API) or Arsenic Trioxide finished formulations upon request. The Arsenic Trioxide suppliers may include Arsenic Trioxide API manufacturers, exporters, distributors and traders.
click here to find a list of Arsenic Trioxide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Arsenic Trioxide DMF (Drug Master File) is a document detailing the whole manufacturing process of Arsenic Trioxide active pharmaceutical ingredient (API) in detail. Different forms of Arsenic Trioxide DMFs exist exist since differing nations have different regulations, such as Arsenic Trioxide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Arsenic Trioxide DMF submitted to regulatory agencies in the US is known as a USDMF. Arsenic Trioxide USDMF includes data on Arsenic Trioxide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Arsenic Trioxide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Arsenic Trioxide 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 Arsenic Trioxide Drug Master File in Japan (Arsenic Trioxide JDMF) empowers Arsenic Trioxide 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 Arsenic Trioxide JDMF during the approval evaluation for pharmaceutical products. At the time of Arsenic Trioxide 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 Arsenic Trioxide suppliers with JDMF 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 Arsenic Trioxide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Arsenic Trioxide 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 Arsenic Trioxide 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 Arsenic Trioxide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Arsenic Trioxide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Arsenic Trioxide suppliers with NDC on PharmaCompass.
Arsenic Trioxide 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 Arsenic Trioxide 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 Arsenic Trioxide GMP manufacturer or Arsenic Trioxide GMP API supplier for your needs.
A Arsenic Trioxide CoA (Certificate of Analysis) is a formal document that attests to Arsenic Trioxide's compliance with Arsenic Trioxide specifications and serves as a tool for batch-level quality control.
Arsenic Trioxide CoA mostly includes findings from lab analyses of a specific batch. For each Arsenic Trioxide 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.
Arsenic Trioxide may be tested according to a variety of international standards, such as European Pharmacopoeia (Arsenic Trioxide EP), Arsenic Trioxide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Arsenic Trioxide USP).
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