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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - POWDER;INTRAVENOUS - EQ 235MG BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL
USFDA APPLICATION NUMBER - 210493
DOSAGE - SOLUTION;INTRAVENOUS - EQ 235MG BASE...DOSAGE - SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)
USFDA APPLICATION NUMBER - 210493
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ABOUT THIS PAGE
A Fosnetupitant chloride hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fosnetupitant chloride hydrochloride, including repackagers and relabelers. The FDA regulates Fosnetupitant chloride hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fosnetupitant chloride hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Fosnetupitant chloride hydrochloride supplier is an individual or a company that provides Fosnetupitant chloride hydrochloride active pharmaceutical ingredient (API) or Fosnetupitant chloride hydrochloride finished formulations upon request. The Fosnetupitant chloride hydrochloride suppliers may include Fosnetupitant chloride hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Fosnetupitant chloride hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fosnetupitant chloride hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Fosnetupitant chloride hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Fosnetupitant chloride hydrochloride DMFs exist exist since differing nations have different regulations, such as Fosnetupitant chloride hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fosnetupitant chloride hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Fosnetupitant chloride hydrochloride USDMF includes data on Fosnetupitant chloride hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fosnetupitant chloride hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fosnetupitant chloride hydrochloride suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Fosnetupitant chloride hydrochloride Drug Master File in Japan (Fosnetupitant chloride hydrochloride JDMF) empowers Fosnetupitant chloride hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Fosnetupitant chloride hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Fosnetupitant chloride hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Fosnetupitant chloride hydrochloride suppliers with JDMF 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 Fosnetupitant chloride hydrochloride Drug Master File in Korea (Fosnetupitant chloride hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fosnetupitant chloride hydrochloride. The MFDS reviews the Fosnetupitant chloride hydrochloride KDMF as part of the drug registration process and uses the information provided in the Fosnetupitant chloride hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fosnetupitant chloride hydrochloride 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 Fosnetupitant chloride hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fosnetupitant chloride hydrochloride 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 Fosnetupitant chloride hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fosnetupitant chloride hydrochloride 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 Fosnetupitant chloride hydrochloride 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 Fosnetupitant chloride hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fosnetupitant chloride hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fosnetupitant chloride hydrochloride suppliers with NDC on PharmaCompass.
Fosnetupitant chloride hydrochloride 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 Fosnetupitant chloride hydrochloride 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 Fosnetupitant chloride hydrochloride GMP manufacturer or Fosnetupitant chloride hydrochloride GMP API supplier for your needs.
A Fosnetupitant chloride hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Fosnetupitant chloride hydrochloride's compliance with Fosnetupitant chloride hydrochloride specifications and serves as a tool for batch-level quality control.
Fosnetupitant chloride hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Fosnetupitant chloride hydrochloride 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.
Fosnetupitant chloride hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Fosnetupitant chloride hydrochloride EP), Fosnetupitant chloride hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fosnetupitant chloride hydrochloride USP).
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