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ABOUT THIS PAGE
A Lomefloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lomefloxacin, including repackagers and relabelers. The FDA regulates Lomefloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lomefloxacin 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 Lomefloxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lomefloxacin supplier is an individual or a company that provides Lomefloxacin active pharmaceutical ingredient (API) or Lomefloxacin finished formulations upon request. The Lomefloxacin suppliers may include Lomefloxacin API manufacturers, exporters, distributors and traders.
click here to find a list of Lomefloxacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lomefloxacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Lomefloxacin active pharmaceutical ingredient (API) in detail. Different forms of Lomefloxacin DMFs exist exist since differing nations have different regulations, such as Lomefloxacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lomefloxacin DMF submitted to regulatory agencies in the US is known as a USDMF. Lomefloxacin USDMF includes data on Lomefloxacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lomefloxacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lomefloxacin 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 Lomefloxacin Drug Master File in Japan (Lomefloxacin JDMF) empowers Lomefloxacin 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 Lomefloxacin JDMF during the approval evaluation for pharmaceutical products. At the time of Lomefloxacin 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 Lomefloxacin 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 Lomefloxacin Drug Master File in Korea (Lomefloxacin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lomefloxacin. The MFDS reviews the Lomefloxacin KDMF as part of the drug registration process and uses the information provided in the Lomefloxacin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lomefloxacin 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 Lomefloxacin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lomefloxacin suppliers with KDMF on PharmaCompass.
A Lomefloxacin written confirmation (Lomefloxacin WC) is an official document issued by a regulatory agency to a Lomefloxacin manufacturer, verifying that the manufacturing facility of a Lomefloxacin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lomefloxacin APIs or Lomefloxacin finished pharmaceutical products to another nation, regulatory agencies frequently require a Lomefloxacin WC (written confirmation) as part of the regulatory process.
click here to find a list of Lomefloxacin suppliers with Written Confirmation (WC) on PharmaCompass.
Lomefloxacin 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 Lomefloxacin 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 Lomefloxacin GMP manufacturer or Lomefloxacin GMP API supplier for your needs.
A Lomefloxacin CoA (Certificate of Analysis) is a formal document that attests to Lomefloxacin's compliance with Lomefloxacin specifications and serves as a tool for batch-level quality control.
Lomefloxacin CoA mostly includes findings from lab analyses of a specific batch. For each Lomefloxacin 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.
Lomefloxacin may be tested according to a variety of international standards, such as European Pharmacopoeia (Lomefloxacin EP), Lomefloxacin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lomefloxacin USP).
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