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API SUPPLIERS
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Inke S.A: APIs manufacturing plant.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
TAPI offers customized CDMO Solutions for API development and manufacturing services.
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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 : 38462
Submission : 2023-06-22
Status :
Type : II
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ABOUT THIS PAGE
A Mavacamten manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mavacamten, including repackagers and relabelers. The FDA regulates Mavacamten manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mavacamten 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 Mavacamten manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mavacamten supplier is an individual or a company that provides Mavacamten active pharmaceutical ingredient (API) or Mavacamten finished formulations upon request. The Mavacamten suppliers may include Mavacamten API manufacturers, exporters, distributors and traders.
click here to find a list of Mavacamten suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mavacamten DMF (Drug Master File) is a document detailing the whole manufacturing process of Mavacamten active pharmaceutical ingredient (API) in detail. Different forms of Mavacamten DMFs exist exist since differing nations have different regulations, such as Mavacamten USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mavacamten DMF submitted to regulatory agencies in the US is known as a USDMF. Mavacamten USDMF includes data on Mavacamten's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mavacamten USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mavacamten suppliers with USDMF 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 Mavacamten as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mavacamten 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 Mavacamten 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 Mavacamten and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mavacamten NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mavacamten suppliers with NDC on PharmaCompass.
Mavacamten 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 Mavacamten 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 Mavacamten GMP manufacturer or Mavacamten GMP API supplier for your needs.
A Mavacamten CoA (Certificate of Analysis) is a formal document that attests to Mavacamten's compliance with Mavacamten specifications and serves as a tool for batch-level quality control.
Mavacamten CoA mostly includes findings from lab analyses of a specific batch. For each Mavacamten 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.
Mavacamten may be tested according to a variety of international standards, such as European Pharmacopoeia (Mavacamten EP), Mavacamten JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mavacamten USP).
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