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CEP/COS
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JDMF
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EU WC
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KDMF
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VMF
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EDQM
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USP
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JP
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Others
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Europe
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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FDF
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2023-08-08
Pay. Date : 2023-06-16
DMF Number : 38498
Submission : 2023-06-23
Status :
Type : II
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
About the Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipients for pharmaceuti...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standar...
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API Imports and Exports
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DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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Main Therapeutic Indication : CNS & Anesthesia
Currency : USD
2020 Revenue in Millions : 125
2019 Revenue in Millions : 0
Growth (%) : New Launch
Main Therapeutic Indication : Neurology
Currency : USD
2021 Revenue in Millions : 552
2020 Revenue in Millions : 125
Growth (%) : 342
Main Therapeutic Indication : Neurology
Currency : USD
2022 Revenue in Millions : 680
2021 Revenue in Millions : 552
Growth (%) : 23
Main Therapeutic Indication : Neurology
Currency : USD
2023 Revenue in Millions : 815
2022 Revenue in Millions : 680
Growth (%) : 20
Main Therapeutic Indication : Neurology
Currency : USD
2024 Revenue in Millions : 1,006
2023 Revenue in Millions : 815
Growth (%) : 23
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US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
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PharmaCompass offers a list of Ubrogepant 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 Ubrogepant manufacturer or Ubrogepant supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ubrogepant manufacturer or Ubrogepant supplier.
PharmaCompass also assists you with knowing the Ubrogepant API Price utilized in the formulation of products. Ubrogepant API Price is not always fixed or binding as the Ubrogepant Price is obtained through a variety of data sources. The Ubrogepant Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ubrogepant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ubrogepant, including repackagers and relabelers. The FDA regulates Ubrogepant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ubrogepant 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 Ubrogepant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ubrogepant supplier is an individual or a company that provides Ubrogepant active pharmaceutical ingredient (API) or Ubrogepant finished formulations upon request. The Ubrogepant suppliers may include Ubrogepant API manufacturers, exporters, distributors and traders.
click here to find a list of Ubrogepant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ubrogepant DMF (Drug Master File) is a document detailing the whole manufacturing process of Ubrogepant active pharmaceutical ingredient (API) in detail. Different forms of Ubrogepant DMFs exist exist since differing nations have different regulations, such as Ubrogepant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ubrogepant DMF submitted to regulatory agencies in the US is known as a USDMF. Ubrogepant USDMF includes data on Ubrogepant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ubrogepant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ubrogepant 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 Ubrogepant as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ubrogepant 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 Ubrogepant 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 Ubrogepant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ubrogepant NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ubrogepant suppliers with NDC on PharmaCompass.
Ubrogepant 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 Ubrogepant 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 Ubrogepant GMP manufacturer or Ubrogepant GMP API supplier for your needs.
A Ubrogepant CoA (Certificate of Analysis) is a formal document that attests to Ubrogepant's compliance with Ubrogepant specifications and serves as a tool for batch-level quality control.
Ubrogepant CoA mostly includes findings from lab analyses of a specific batch. For each Ubrogepant 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.
Ubrogepant may be tested according to a variety of international standards, such as European Pharmacopoeia (Ubrogepant EP), Ubrogepant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ubrogepant USP).
