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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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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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09 Apr 2024
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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 Nurtec odt (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nurtec odt (TN), including repackagers and relabelers. The FDA regulates Nurtec odt (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nurtec odt (TN) 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 Nurtec odt (TN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nurtec odt (TN) supplier is an individual or a company that provides Nurtec odt (TN) active pharmaceutical ingredient (API) or Nurtec odt (TN) finished formulations upon request. The Nurtec odt (TN) suppliers may include Nurtec odt (TN) API manufacturers, exporters, distributors and traders.
click here to find a list of Nurtec odt (TN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nurtec odt (TN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Nurtec odt (TN) active pharmaceutical ingredient (API) in detail. Different forms of Nurtec odt (TN) DMFs exist exist since differing nations have different regulations, such as Nurtec odt (TN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nurtec odt (TN) DMF submitted to regulatory agencies in the US is known as a USDMF. Nurtec odt (TN) USDMF includes data on Nurtec odt (TN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nurtec odt (TN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nurtec odt (TN) 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 Nurtec odt (TN) Drug Master File in Korea (Nurtec odt (TN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nurtec odt (TN). The MFDS reviews the Nurtec odt (TN) KDMF as part of the drug registration process and uses the information provided in the Nurtec odt (TN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nurtec odt (TN) 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 Nurtec odt (TN) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nurtec odt (TN) suppliers with KDMF on PharmaCompass.
A Nurtec odt (TN) written confirmation (Nurtec odt (TN) WC) is an official document issued by a regulatory agency to a Nurtec odt (TN) manufacturer, verifying that the manufacturing facility of a Nurtec odt (TN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nurtec odt (TN) APIs or Nurtec odt (TN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Nurtec odt (TN) WC (written confirmation) as part of the regulatory process.
click here to find a list of Nurtec odt (TN) 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 Nurtec odt (TN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nurtec odt (TN) 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 Nurtec odt (TN) 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 Nurtec odt (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nurtec odt (TN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nurtec odt (TN) suppliers with NDC on PharmaCompass.
Nurtec odt (TN) 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 Nurtec odt (TN) 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 Nurtec odt (TN) GMP manufacturer or Nurtec odt (TN) GMP API supplier for your needs.
A Nurtec odt (TN) CoA (Certificate of Analysis) is a formal document that attests to Nurtec odt (TN)'s compliance with Nurtec odt (TN) specifications and serves as a tool for batch-level quality control.
Nurtec odt (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Nurtec odt (TN) 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.
Nurtec odt (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Nurtec odt (TN) EP), Nurtec odt (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nurtec odt (TN) USP).
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