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