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API SUPPLIERS
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-14
Pay. Date : 2023-09-26
DMF Number : 37797
Submission : 2022-12-23
Status :
Type : II
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Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since its founding in 1962, MOEHS has produced Active Pharmaceutical Ingredients (APIs) for the international pharmaceutical industry. Thanks to a business history of more than 50 ...
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...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
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...
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
About the Company : Tagoor Laboratories, established in 2018, is a part of the Tagoor Group. It specializes in providing APIs, advanced intermediates and key starting materials for critical and high-g...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
(6S,9R)-6-(2,3-Difluorophenyl)-6,7,8,9-tetrahydro-...
CAS Number : 1190363-46-2
End Use API : Rimegepant Sulfate
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
1-piperidin-4-yl-3H-imidazo[4,5-b]pyridin-2-one,di...
CAS Number : 781649-84-1
End Use API : Rimegepant Sulfate
About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
2-oxo-1-(4-piperidinyl)-2,3- dihydro-1H-imidazo[4,...
CAS Number : 781649-84-1
End Use API : Rimegepant Sulfate
About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
9-((triisopropylsilyl)oxy)-6,7,8,9- tetrahydro-5Hc...
CAS Number : 1190363-45-1
End Use API : Rimegepant Sulfate
About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...
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11 Jun 2024
// Fraiser Kansteiner FIERCE PHARMA
09 Apr 2024
// Beth Snyder Bulik ENDPTS
13 Sep 2023
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17 Jun 2023
// REUTERS
01 Jun 2023
// Paul Schloesser ENDPTS
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PharmaCompass offers a list of Rimegepant Sulfate 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 Rimegepant Sulfate manufacturer or Rimegepant Sulfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rimegepant Sulfate manufacturer or Rimegepant Sulfate supplier.
PharmaCompass also assists you with knowing the Rimegepant Sulfate API Price utilized in the formulation of products. Rimegepant Sulfate API Price is not always fixed or binding as the Rimegepant Sulfate Price is obtained through a variety of data sources. The Rimegepant Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rimegepant manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rimegepant, including repackagers and relabelers. The FDA regulates Rimegepant manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rimegepant 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 Rimegepant manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rimegepant supplier is an individual or a company that provides Rimegepant active pharmaceutical ingredient (API) or Rimegepant finished formulations upon request. The Rimegepant suppliers may include Rimegepant API manufacturers, exporters, distributors and traders.
click here to find a list of Rimegepant suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rimegepant DMF (Drug Master File) is a document detailing the whole manufacturing process of Rimegepant active pharmaceutical ingredient (API) in detail. Different forms of Rimegepant DMFs exist exist since differing nations have different regulations, such as Rimegepant USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rimegepant DMF submitted to regulatory agencies in the US is known as a USDMF. Rimegepant USDMF includes data on Rimegepant's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rimegepant USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rimegepant 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 Rimegepant Drug Master File in Korea (Rimegepant KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rimegepant. The MFDS reviews the Rimegepant KDMF as part of the drug registration process and uses the information provided in the Rimegepant KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rimegepant 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 Rimegepant API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rimegepant suppliers with KDMF on PharmaCompass.
A Rimegepant written confirmation (Rimegepant WC) is an official document issued by a regulatory agency to a Rimegepant manufacturer, verifying that the manufacturing facility of a Rimegepant active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rimegepant APIs or Rimegepant finished pharmaceutical products to another nation, regulatory agencies frequently require a Rimegepant WC (written confirmation) as part of the regulatory process.
click here to find a list of Rimegepant 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 Rimegepant as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rimegepant 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 Rimegepant 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 Rimegepant and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rimegepant NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rimegepant suppliers with NDC on PharmaCompass.
Rimegepant 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 Rimegepant 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 Rimegepant GMP manufacturer or Rimegepant GMP API supplier for your needs.
A Rimegepant CoA (Certificate of Analysis) is a formal document that attests to Rimegepant's compliance with Rimegepant specifications and serves as a tool for batch-level quality control.
Rimegepant CoA mostly includes findings from lab analyses of a specific batch. For each Rimegepant 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.
Rimegepant may be tested according to a variety of international standards, such as European Pharmacopoeia (Rimegepant EP), Rimegepant JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rimegepant USP).
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