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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - EQ 400MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21085
DOSAGE - SOLUTION;INTRAVENOUS - 400MG/250ML (...DOSAGE - SOLUTION;INTRAVENOUS - 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21277
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE
USFDA APPLICATION NUMBER - 21598
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ABOUT THIS PAGE
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PharmaCompass offers a list of Moxifloxacin Hydrochloride 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 Moxifloxacin Hydrochloride manufacturer or Moxifloxacin Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Moxifloxacin Hydrochloride manufacturer or Moxifloxacin Hydrochloride supplier.
PharmaCompass also assists you with knowing the Moxifloxacin Hydrochloride API Price utilized in the formulation of products. Moxifloxacin Hydrochloride API Price is not always fixed or binding as the Moxifloxacin Hydrochloride Price is obtained through a variety of data sources. The Moxifloxacin Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Avelox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Avelox, including repackagers and relabelers. The FDA regulates Avelox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Avelox 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 Avelox manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Avelox supplier is an individual or a company that provides Avelox active pharmaceutical ingredient (API) or Avelox finished formulations upon request. The Avelox suppliers may include Avelox API manufacturers, exporters, distributors and traders.
click here to find a list of Avelox suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Avelox DMF (Drug Master File) is a document detailing the whole manufacturing process of Avelox active pharmaceutical ingredient (API) in detail. Different forms of Avelox DMFs exist exist since differing nations have different regulations, such as Avelox USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Avelox DMF submitted to regulatory agencies in the US is known as a USDMF. Avelox USDMF includes data on Avelox's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Avelox USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Avelox 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 Avelox Drug Master File in Japan (Avelox JDMF) empowers Avelox 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 Avelox JDMF during the approval evaluation for pharmaceutical products. At the time of Avelox 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 Avelox 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 Avelox Drug Master File in Korea (Avelox KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Avelox. The MFDS reviews the Avelox KDMF as part of the drug registration process and uses the information provided in the Avelox KDMF to evaluate the safety and efficacy of the drug.
After submitting a Avelox 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 Avelox API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Avelox suppliers with KDMF on PharmaCompass.
A Avelox CEP of the European Pharmacopoeia monograph is often referred to as a Avelox Certificate of Suitability (COS). The purpose of a Avelox CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Avelox EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Avelox to their clients by showing that a Avelox CEP has been issued for it. The manufacturer submits a Avelox CEP (COS) as part of the market authorization procedure, and it takes on the role of a Avelox CEP holder for the record. Additionally, the data presented in the Avelox CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Avelox DMF.
A Avelox CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Avelox CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Avelox suppliers with CEP (COS) on PharmaCompass.
A Avelox written confirmation (Avelox WC) is an official document issued by a regulatory agency to a Avelox manufacturer, verifying that the manufacturing facility of a Avelox active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Avelox APIs or Avelox finished pharmaceutical products to another nation, regulatory agencies frequently require a Avelox WC (written confirmation) as part of the regulatory process.
click here to find a list of Avelox 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 Avelox as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Avelox 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 Avelox 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 Avelox and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Avelox NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Avelox suppliers with NDC on PharmaCompass.
Avelox 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 Avelox 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 Avelox GMP manufacturer or Avelox GMP API supplier for your needs.
A Avelox CoA (Certificate of Analysis) is a formal document that attests to Avelox's compliance with Avelox specifications and serves as a tool for batch-level quality control.
Avelox CoA mostly includes findings from lab analyses of a specific batch. For each Avelox 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.
Avelox may be tested according to a variety of international standards, such as European Pharmacopoeia (Avelox EP), Avelox JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Avelox USP).
