X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
30
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 Moxifloxacin HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Moxifloxacin HCl, including repackagers and relabelers. The FDA regulates Moxifloxacin HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Moxifloxacin HCl 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 Moxifloxacin HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Moxifloxacin HCl supplier is an individual or a company that provides Moxifloxacin HCl active pharmaceutical ingredient (API) or Moxifloxacin HCl finished formulations upon request. The Moxifloxacin HCl suppliers may include Moxifloxacin HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Moxifloxacin HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Moxifloxacin HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Moxifloxacin HCl active pharmaceutical ingredient (API) in detail. Different forms of Moxifloxacin HCl DMFs exist exist since differing nations have different regulations, such as Moxifloxacin HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Moxifloxacin HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Moxifloxacin HCl USDMF includes data on Moxifloxacin HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Moxifloxacin HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Moxifloxacin HCl 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 Moxifloxacin HCl Drug Master File in Japan (Moxifloxacin HCl JDMF) empowers Moxifloxacin HCl 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 Moxifloxacin HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Moxifloxacin HCl 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 Moxifloxacin HCl 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 Moxifloxacin HCl Drug Master File in Korea (Moxifloxacin HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Moxifloxacin HCl. The MFDS reviews the Moxifloxacin HCl KDMF as part of the drug registration process and uses the information provided in the Moxifloxacin HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Moxifloxacin HCl 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 Moxifloxacin HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Moxifloxacin HCl suppliers with KDMF on PharmaCompass.
A Moxifloxacin HCl CEP of the European Pharmacopoeia monograph is often referred to as a Moxifloxacin HCl Certificate of Suitability (COS). The purpose of a Moxifloxacin HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Moxifloxacin HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Moxifloxacin HCl to their clients by showing that a Moxifloxacin HCl CEP has been issued for it. The manufacturer submits a Moxifloxacin HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Moxifloxacin HCl CEP holder for the record. Additionally, the data presented in the Moxifloxacin HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Moxifloxacin HCl DMF.
A Moxifloxacin HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Moxifloxacin HCl 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 Moxifloxacin HCl suppliers with CEP (COS) on PharmaCompass.
A Moxifloxacin HCl written confirmation (Moxifloxacin HCl WC) is an official document issued by a regulatory agency to a Moxifloxacin HCl manufacturer, verifying that the manufacturing facility of a Moxifloxacin HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Moxifloxacin HCl APIs or Moxifloxacin HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Moxifloxacin HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Moxifloxacin HCl 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 Moxifloxacin HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Moxifloxacin HCl 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 Moxifloxacin HCl 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 Moxifloxacin HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Moxifloxacin HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Moxifloxacin HCl suppliers with NDC on PharmaCompass.
Moxifloxacin HCl 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 Moxifloxacin HCl 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 Moxifloxacin HCl GMP manufacturer or Moxifloxacin HCl GMP API supplier for your needs.
A Moxifloxacin HCl CoA (Certificate of Analysis) is a formal document that attests to Moxifloxacin HCl's compliance with Moxifloxacin HCl specifications and serves as a tool for batch-level quality control.
Moxifloxacin HCl CoA mostly includes findings from lab analyses of a specific batch. For each Moxifloxacin HCl 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.
Moxifloxacin HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Moxifloxacin HCl EP), Moxifloxacin HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Moxifloxacin HCl USP).
Market Place
