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API SUPPLIERS
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-01
Pay. Date : 2019-01-28
DMF Number : 17012
Submission : 2003-12-02
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16965
Submission : 2003-11-17
Status :
Type : II
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Gatifloxacin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gatifloxacin, including repackagers and relabelers. The FDA regulates Gatifloxacin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gatifloxacin 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 Gatifloxacin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gatifloxacin supplier is an individual or a company that provides Gatifloxacin active pharmaceutical ingredient (API) or Gatifloxacin finished formulations upon request. The Gatifloxacin suppliers may include Gatifloxacin API manufacturers, exporters, distributors and traders.
click here to find a list of Gatifloxacin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gatifloxacin DMF (Drug Master File) is a document detailing the whole manufacturing process of Gatifloxacin active pharmaceutical ingredient (API) in detail. Different forms of Gatifloxacin DMFs exist exist since differing nations have different regulations, such as Gatifloxacin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gatifloxacin DMF submitted to regulatory agencies in the US is known as a USDMF. Gatifloxacin USDMF includes data on Gatifloxacin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gatifloxacin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gatifloxacin 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 Gatifloxacin Drug Master File in Japan (Gatifloxacin JDMF) empowers Gatifloxacin 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 Gatifloxacin JDMF during the approval evaluation for pharmaceutical products. At the time of Gatifloxacin 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 Gatifloxacin 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 Gatifloxacin Drug Master File in Korea (Gatifloxacin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gatifloxacin. The MFDS reviews the Gatifloxacin KDMF as part of the drug registration process and uses the information provided in the Gatifloxacin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gatifloxacin 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 Gatifloxacin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gatifloxacin suppliers with KDMF on PharmaCompass.
A Gatifloxacin written confirmation (Gatifloxacin WC) is an official document issued by a regulatory agency to a Gatifloxacin manufacturer, verifying that the manufacturing facility of a Gatifloxacin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gatifloxacin APIs or Gatifloxacin finished pharmaceutical products to another nation, regulatory agencies frequently require a Gatifloxacin WC (written confirmation) as part of the regulatory process.
click here to find a list of Gatifloxacin 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 Gatifloxacin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gatifloxacin 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 Gatifloxacin 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 Gatifloxacin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gatifloxacin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gatifloxacin suppliers with NDC on PharmaCompass.
Gatifloxacin 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 Gatifloxacin 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 Gatifloxacin GMP manufacturer or Gatifloxacin GMP API supplier for your needs.
A Gatifloxacin CoA (Certificate of Analysis) is a formal document that attests to Gatifloxacin's compliance with Gatifloxacin specifications and serves as a tool for batch-level quality control.
Gatifloxacin CoA mostly includes findings from lab analyses of a specific batch. For each Gatifloxacin 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.
Gatifloxacin may be tested according to a variety of international standards, such as European Pharmacopoeia (Gatifloxacin EP), Gatifloxacin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gatifloxacin USP).
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