Synopsis
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CEP/COS
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JDMF
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EU WC
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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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Australia
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South Africa
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
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
Registrant Name : AbbVie Korea Co., Ltd.
Registration Date : 2025-02-25
Registration Number : Su325-15-ND
Manufacturer Name : AbbVie Operations Singapore ...
Manufacturer Address : 23 Tuas South Avenue 6, 637022 Singapore
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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...
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/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
Regulatory Info :
Registration Country : Norway
Brand Name : Aquipta
Dosage Form : Tablet
Dosage Strength : 60 mg
Packaging : Blisterpakning 28item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Aquipta
Dosage Form : Tablet
Dosage Strength : 10 mg
Packaging : Blisterpakning 28item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Aquipta
Dosage Form : Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 11/08/2023
Application Number : 20220625000016
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Aquipta
Dosage Form : Tablet
Dosage Strength : 60mg
Packaging :
Approval Date : 11/08/2023
Application Number : 20220625000023
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : AQUIPTA
Dosage Form : Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 06/03/2024
Application Number : 69128
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : AQUIPTA
Dosage Form : Tablet
Dosage Strength : 60mg
Packaging :
Approval Date : 06/03/2024
Application Number : 69128
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Aquipta
Dosage Form : Tablet
Dosage Strength : 10MG
Packaging :
Approval Date : 2023-10-27
Application Number : 1231750001
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Aquipta
Dosage Form : Tablet
Dosage Strength : 60MG
Packaging :
Approval Date : 2023-10-27
Application Number : 1231750003
Regulatory Info : Authorized
Registration Country : Spain
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DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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Main Therapeutic Indication : Neurology
Currency : USD
2022 Revenue in Millions : 158
2021 Revenue in Millions : 0
Growth (%) : New Launch in 2022
Main Therapeutic Indication : Neurology
Currency : USD
2023 Revenue in Millions : 408
2022 Revenue in Millions : 158
Growth (%) : 158
Main Therapeutic Indication : Neurology
Currency : USD
2024 Revenue in Millions : 658
2023 Revenue in Millions : 408
Growth (%) : 61
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US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]US Exclusivities
Exclusivity Code : I-909
Exclusivity Expiration Date : 2026-04-17
Application Number : 215206
Product Number : 1
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2026-09-28
Application Number : 215206
Product Number : 1
Exclusivity Details :
Exclusivity Code : I-909
Exclusivity Expiration Date : 2026-04-17
Application Number : 215206
Product Number : 2
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2026-09-28
Application Number : 215206
Product Number : 2
Exclusivity Details :
Exclusivity Code : I-909
Exclusivity Expiration Date : 2026-04-17
Application Number : 215206
Product Number : 3
Exclusivity Details :
Exclusivity Code : NCE
Exclusivity Expiration Date : 2026-09-28
Application Number : 215206
Product Number : 3
Exclusivity Details :
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 Atogepant 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 Atogepant manufacturer or Atogepant supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Atogepant manufacturer or Atogepant supplier.
PharmaCompass also assists you with knowing the Atogepant API Price utilized in the formulation of products. Atogepant API Price is not always fixed or binding as the Atogepant Price is obtained through a variety of data sources. The Atogepant Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Atogepant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atogepant, including repackagers and relabelers. The FDA regulates Atogepant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atogepant 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 Atogepant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Atogepant supplier is an individual or a company that provides Atogepant active pharmaceutical ingredient (API) or Atogepant finished formulations upon request. The Atogepant suppliers may include Atogepant API manufacturers, exporters, distributors and traders.
click here to find a list of Atogepant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Atogepant DMF (Drug Master File) is a document detailing the whole manufacturing process of Atogepant active pharmaceutical ingredient (API) in detail. Different forms of Atogepant DMFs exist exist since differing nations have different regulations, such as Atogepant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Atogepant DMF submitted to regulatory agencies in the US is known as a USDMF. Atogepant USDMF includes data on Atogepant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Atogepant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Atogepant 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 Atogepant Drug Master File in Korea (Atogepant KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Atogepant. The MFDS reviews the Atogepant KDMF as part of the drug registration process and uses the information provided in the Atogepant KDMF to evaluate the safety and efficacy of the drug.
After submitting a Atogepant 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 Atogepant API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Atogepant suppliers with KDMF 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 Atogepant as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Atogepant 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 Atogepant 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 Atogepant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Atogepant NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Atogepant suppliers with NDC on PharmaCompass.
Atogepant 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 Atogepant 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 Atogepant GMP manufacturer or Atogepant GMP API supplier for your needs.
A Atogepant CoA (Certificate of Analysis) is a formal document that attests to Atogepant's compliance with Atogepant specifications and serves as a tool for batch-level quality control.
Atogepant CoA mostly includes findings from lab analyses of a specific batch. For each Atogepant 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.
Atogepant may be tested according to a variety of international standards, such as European Pharmacopoeia (Atogepant EP), Atogepant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Atogepant USP).
