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Looking for 112811-59-3 / Gatifloxacin API manufacturers, exporters & distributors?

Gatifloxacin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Gatifloxacin 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 Gatifloxacin manufacturer or Gatifloxacin supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Gatifloxacin manufacturer or Gatifloxacin supplier.

PharmaCompass also assists you with knowing the Gatifloxacin API Price utilized in the formulation of products. Gatifloxacin API Price is not always fixed or binding as the Gatifloxacin Price is obtained through a variety of data sources. The Gatifloxacin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Gatifloxacin

Synonyms

112811-59-3, Tequin, Gatiflo, Zymar, Am-1155, Zymaxid

Cas Number

112811-59-3

Unique Ingredient Identifier (UNII)

81485Y3A9A

About Gatifloxacin

A fluoroquinolone antibacterial agent and DNA TOPOISOMERASE II inhibitor that is used as an ophthalmic solution for the treatment of BACTERIAL CONJUNCTIVITIS.

AM 1155 Manufacturers

A AM 1155 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AM 1155, including repackagers and relabelers. The FDA regulates AM 1155 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AM 1155 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 AM 1155 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

AM 1155 Suppliers

A AM 1155 supplier is an individual or a company that provides AM 1155 active pharmaceutical ingredient (API) or AM 1155 finished formulations upon request. The AM 1155 suppliers may include AM 1155 API manufacturers, exporters, distributors and traders.

click here to find a list of AM 1155 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

AM 1155 USDMF

A AM 1155 DMF (Drug Master File) is a document detailing the whole manufacturing process of AM 1155 active pharmaceutical ingredient (API) in detail. Different forms of AM 1155 DMFs exist exist since differing nations have different regulations, such as AM 1155 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A AM 1155 DMF submitted to regulatory agencies in the US is known as a USDMF. AM 1155 USDMF includes data on AM 1155's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AM 1155 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of AM 1155 suppliers with USDMF on PharmaCompass.

AM 1155 JDMF

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 AM 1155 Drug Master File in Japan (AM 1155 JDMF) empowers AM 1155 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 AM 1155 JDMF during the approval evaluation for pharmaceutical products. At the time of AM 1155 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 AM 1155 suppliers with JDMF on PharmaCompass.

AM 1155 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a AM 1155 Drug Master File in Korea (AM 1155 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AM 1155. The MFDS reviews the AM 1155 KDMF as part of the drug registration process and uses the information provided in the AM 1155 KDMF to evaluate the safety and efficacy of the drug.

After submitting a AM 1155 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 AM 1155 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of AM 1155 suppliers with KDMF on PharmaCompass.

AM 1155 WC

A AM 1155 written confirmation (AM 1155 WC) is an official document issued by a regulatory agency to a AM 1155 manufacturer, verifying that the manufacturing facility of a AM 1155 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AM 1155 APIs or AM 1155 finished pharmaceutical products to another nation, regulatory agencies frequently require a AM 1155 WC (written confirmation) as part of the regulatory process.

click here to find a list of AM 1155 suppliers with Written Confirmation (WC) on PharmaCompass.

AM 1155 NDC

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 AM 1155 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for AM 1155 API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 AM 1155 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain AM 1155 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AM 1155 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of AM 1155 suppliers with NDC on PharmaCompass.

AM 1155 GMP

AM 1155 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 AM 1155 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 AM 1155 GMP manufacturer or AM 1155 GMP API supplier for your needs.

AM 1155 CoA

A AM 1155 CoA (Certificate of Analysis) is a formal document that attests to AM 1155's compliance with AM 1155 specifications and serves as a tool for batch-level quality control.

AM 1155 CoA mostly includes findings from lab analyses of a specific batch. For each AM 1155 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.

AM 1155 may be tested according to a variety of international standards, such as European Pharmacopoeia (AM 1155 EP), AM 1155 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AM 1155 USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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