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ABOUT THIS PAGE
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).
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