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CEP/COS
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EU WC
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JP
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South Africa
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Listed Dossiers
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Stock Recap #PipelineProspector
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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.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Maithri Drugs: Dedicated to your API needs.
BR
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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
Maithri Drugs: Dedicated to your API needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39772
Submission : 2024-03-29
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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 ...
Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
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...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer of Finished Formulat...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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...
Maithri Drugs: Dedicated to your API needs.
About the Company : Maithri Drugs Pvt. Ltd. is a trusted global partner in Active Pharmaceutical Ingredients (APIs), supplying to pharmaceutical leaders in 60+ countries. With APIs spanning antivirals...
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PharmaCompass offers a list of Mavacamten 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 Mavacamten manufacturer or Mavacamten supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mavacamten manufacturer or Mavacamten supplier.
PharmaCompass also assists you with knowing the Mavacamten API Price utilized in the formulation of products. Mavacamten API Price is not always fixed or binding as the Mavacamten Price is obtained through a variety of data sources. The Mavacamten Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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).
