Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
FDF
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
KDMF
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40455
Submission : 2024-09-05
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
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. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...
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...
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
About the Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It has been fostering g...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
ABOUT THIS PAGE
40
PharmaCompass offers a list of Baloxavir Marboxil 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 Baloxavir Marboxil manufacturer or Baloxavir Marboxil supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Baloxavir Marboxil manufacturer or Baloxavir Marboxil supplier.
PharmaCompass also assists you with knowing the Baloxavir Marboxil API Price utilized in the formulation of products. Baloxavir Marboxil API Price is not always fixed or binding as the Baloxavir Marboxil Price is obtained through a variety of data sources. The Baloxavir Marboxil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Baloxavir Marboxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Baloxavir Marboxil, including repackagers and relabelers. The FDA regulates Baloxavir Marboxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Baloxavir Marboxil 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 Baloxavir Marboxil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Baloxavir Marboxil supplier is an individual or a company that provides Baloxavir Marboxil active pharmaceutical ingredient (API) or Baloxavir Marboxil finished formulations upon request. The Baloxavir Marboxil suppliers may include Baloxavir Marboxil API manufacturers, exporters, distributors and traders.
click here to find a list of Baloxavir Marboxil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Baloxavir Marboxil DMF (Drug Master File) is a document detailing the whole manufacturing process of Baloxavir Marboxil active pharmaceutical ingredient (API) in detail. Different forms of Baloxavir Marboxil DMFs exist exist since differing nations have different regulations, such as Baloxavir Marboxil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Baloxavir Marboxil DMF submitted to regulatory agencies in the US is known as a USDMF. Baloxavir Marboxil USDMF includes data on Baloxavir Marboxil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Baloxavir Marboxil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Baloxavir Marboxil 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 Baloxavir Marboxil Drug Master File in Korea (Baloxavir Marboxil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Baloxavir Marboxil. The MFDS reviews the Baloxavir Marboxil KDMF as part of the drug registration process and uses the information provided in the Baloxavir Marboxil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Baloxavir Marboxil 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 Baloxavir Marboxil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Baloxavir Marboxil 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 Baloxavir Marboxil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Baloxavir Marboxil 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 Baloxavir Marboxil 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 Baloxavir Marboxil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Baloxavir Marboxil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Baloxavir Marboxil suppliers with NDC on PharmaCompass.
Baloxavir Marboxil 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 Baloxavir Marboxil 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 Baloxavir Marboxil GMP manufacturer or Baloxavir Marboxil GMP API supplier for your needs.
A Baloxavir Marboxil CoA (Certificate of Analysis) is a formal document that attests to Baloxavir Marboxil's compliance with Baloxavir Marboxil specifications and serves as a tool for batch-level quality control.
Baloxavir Marboxil CoA mostly includes findings from lab analyses of a specific batch. For each Baloxavir Marboxil 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.
Baloxavir Marboxil may be tested according to a variety of international standards, such as European Pharmacopoeia (Baloxavir Marboxil EP), Baloxavir Marboxil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Baloxavir Marboxil USP).
