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API SUPPLIERS
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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...
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...
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
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 & operation facilities ar...
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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ABOUT THIS PAGE
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PharmaCompass offers a list of Rimegepant 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 manufacturer or Rimegepant supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rimegepant manufacturer or Rimegepant supplier.
PharmaCompass also assists you with knowing the Rimegepant API Price utilized in the formulation of products. Rimegepant API Price is not always fixed or binding as the Rimegepant Price is obtained through a variety of data sources. The Rimegepant Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rimegepant Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rimegepant Sulfate, including repackagers and relabelers. The FDA regulates Rimegepant Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rimegepant Sulfate 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 Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rimegepant Sulfate supplier is an individual or a company that provides Rimegepant Sulfate active pharmaceutical ingredient (API) or Rimegepant Sulfate finished formulations upon request. The Rimegepant Sulfate suppliers may include Rimegepant Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Rimegepant Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rimegepant Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Rimegepant Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Rimegepant Sulfate DMFs exist exist since differing nations have different regulations, such as Rimegepant Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rimegepant Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Rimegepant Sulfate USDMF includes data on Rimegepant Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rimegepant Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rimegepant Sulfate 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 Sulfate Drug Master File in Korea (Rimegepant Sulfate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rimegepant Sulfate. The MFDS reviews the Rimegepant Sulfate KDMF as part of the drug registration process and uses the information provided in the Rimegepant Sulfate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rimegepant Sulfate 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 Sulfate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rimegepant Sulfate 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 Rimegepant Sulfate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rimegepant Sulfate 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 Sulfate 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 Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rimegepant Sulfate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rimegepant Sulfate suppliers with NDC on PharmaCompass.
Rimegepant Sulfate 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 Sulfate 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 Sulfate GMP manufacturer or Rimegepant Sulfate GMP API supplier for your needs.
A Rimegepant Sulfate CoA (Certificate of Analysis) is a formal document that attests to Rimegepant Sulfate's compliance with Rimegepant Sulfate specifications and serves as a tool for batch-level quality control.
Rimegepant Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Rimegepant Sulfate 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 Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Rimegepant Sulfate EP), Rimegepant Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rimegepant Sulfate USP).
