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USDMF
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38222
Submission : 2023-03-27
Status :
Type : II
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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...
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 ...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical com...
Lee Pharma Ltd: Global supplier of certified APIs and formulations, driven by innovation and regulatory excellence.
About the Company : Lee Pharma Ltd, established in 1997, is a research-driven pharmaceutical company focused on developing, synthesizing, and commercializing high-quality APIs, intermediates, and fini...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Lasmiditan 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 Lasmiditan manufacturer or Lasmiditan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lasmiditan manufacturer or Lasmiditan supplier.
PharmaCompass also assists you with knowing the Lasmiditan API Price utilized in the formulation of products. Lasmiditan API Price is not always fixed or binding as the Lasmiditan Price is obtained through a variety of data sources. The Lasmiditan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lasmiditan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lasmiditan, including repackagers and relabelers. The FDA regulates Lasmiditan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lasmiditan 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 Lasmiditan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lasmiditan supplier is an individual or a company that provides Lasmiditan active pharmaceutical ingredient (API) or Lasmiditan finished formulations upon request. The Lasmiditan suppliers may include Lasmiditan API manufacturers, exporters, distributors and traders.
click here to find a list of Lasmiditan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lasmiditan DMF (Drug Master File) is a document detailing the whole manufacturing process of Lasmiditan active pharmaceutical ingredient (API) in detail. Different forms of Lasmiditan DMFs exist exist since differing nations have different regulations, such as Lasmiditan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lasmiditan DMF submitted to regulatory agencies in the US is known as a USDMF. Lasmiditan USDMF includes data on Lasmiditan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lasmiditan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lasmiditan 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 Lasmiditan Drug Master File in Korea (Lasmiditan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lasmiditan. The MFDS reviews the Lasmiditan KDMF as part of the drug registration process and uses the information provided in the Lasmiditan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lasmiditan 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 Lasmiditan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lasmiditan 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 Lasmiditan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lasmiditan 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 Lasmiditan 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 Lasmiditan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lasmiditan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lasmiditan suppliers with NDC on PharmaCompass.
Lasmiditan 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 Lasmiditan 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 Lasmiditan GMP manufacturer or Lasmiditan GMP API supplier for your needs.
A Lasmiditan CoA (Certificate of Analysis) is a formal document that attests to Lasmiditan's compliance with Lasmiditan specifications and serves as a tool for batch-level quality control.
Lasmiditan CoA mostly includes findings from lab analyses of a specific batch. For each Lasmiditan 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.
Lasmiditan may be tested according to a variety of international standards, such as European Pharmacopoeia (Lasmiditan EP), Lasmiditan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lasmiditan USP).
