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