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PharmaCompass offers a list of Gemifloxacin 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 Gemifloxacin manufacturer or Gemifloxacin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gemifloxacin manufacturer or Gemifloxacin supplier.
PharmaCompass also assists you with knowing the Gemifloxacin API Price utilized in the formulation of products. Gemifloxacin API Price is not always fixed or binding as the Gemifloxacin Price is obtained through a variety of data sources. The Gemifloxacin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Gemifloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gemifloxacin, including repackagers and relabelers. The FDA regulates Gemifloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gemifloxacin 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 Gemifloxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gemifloxacin supplier is an individual or a company that provides Gemifloxacin active pharmaceutical ingredient (API) or Gemifloxacin finished formulations upon request. The Gemifloxacin suppliers may include Gemifloxacin API manufacturers, exporters, distributors and traders.
click here to find a list of Gemifloxacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gemifloxacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Gemifloxacin active pharmaceutical ingredient (API) in detail. Different forms of Gemifloxacin DMFs exist exist since differing nations have different regulations, such as Gemifloxacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gemifloxacin DMF submitted to regulatory agencies in the US is known as a USDMF. Gemifloxacin USDMF includes data on Gemifloxacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gemifloxacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gemifloxacin 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 Gemifloxacin Drug Master File in Korea (Gemifloxacin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gemifloxacin. The MFDS reviews the Gemifloxacin KDMF as part of the drug registration process and uses the information provided in the Gemifloxacin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gemifloxacin 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 Gemifloxacin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gemifloxacin suppliers with KDMF on PharmaCompass.
A Gemifloxacin written confirmation (Gemifloxacin WC) is an official document issued by a regulatory agency to a Gemifloxacin manufacturer, verifying that the manufacturing facility of a Gemifloxacin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gemifloxacin APIs or Gemifloxacin finished pharmaceutical products to another nation, regulatory agencies frequently require a Gemifloxacin WC (written confirmation) as part of the regulatory process.
click here to find a list of Gemifloxacin 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 Gemifloxacin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gemifloxacin 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 Gemifloxacin 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 Gemifloxacin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gemifloxacin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gemifloxacin suppliers with NDC on PharmaCompass.
Gemifloxacin 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 Gemifloxacin 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 Gemifloxacin GMP manufacturer or Gemifloxacin GMP API supplier for your needs.
A Gemifloxacin CoA (Certificate of Analysis) is a formal document that attests to Gemifloxacin's compliance with Gemifloxacin specifications and serves as a tool for batch-level quality control.
Gemifloxacin CoA mostly includes findings from lab analyses of a specific batch. For each Gemifloxacin 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.
Gemifloxacin may be tested according to a variety of international standards, such as European Pharmacopoeia (Gemifloxacin EP), Gemifloxacin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gemifloxacin USP).
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