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Looking for 70458-96-7 / Norfloxacin API manufacturers, exporters & distributors?

Norfloxacin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Norfloxacin

Synonyms

70458-96-7, Noroxin, Norfloxacine, Chibroxin, Baccidal, Sebercim

Cas Number

70458-96-7

Unique Ingredient Identifier (UNII)

N0F8P22L1P

About Norfloxacin

A synthetic fluoroquinolone (FLUOROQUINOLONES) with broad-spectrum antibacterial activity against most gram-negative and gram-positive bacteria. Norfloxacin inhibits bacterial DNA GYRASE.

AM 715 Manufacturers

A AM 715 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AM 715, including repackagers and relabelers. The FDA regulates AM 715 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AM 715 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 715 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

AM 715 Suppliers

A AM 715 supplier is an individual or a company that provides AM 715 active pharmaceutical ingredient (API) or AM 715 finished formulations upon request. The AM 715 suppliers may include AM 715 API manufacturers, exporters, distributors and traders.

click here to find a list of AM 715 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

AM 715 USDMF

A AM 715 DMF (Drug Master File) is a document detailing the whole manufacturing process of AM 715 active pharmaceutical ingredient (API) in detail. Different forms of AM 715 DMFs exist exist since differing nations have different regulations, such as AM 715 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A AM 715 DMF submitted to regulatory agencies in the US is known as a USDMF. AM 715 USDMF includes data on AM 715's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AM 715 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of AM 715 suppliers with USDMF on PharmaCompass.

AM 715 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 715 Drug Master File in Japan (AM 715 JDMF) empowers AM 715 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 715 JDMF during the approval evaluation for pharmaceutical products. At the time of AM 715 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 715 suppliers with JDMF on PharmaCompass.

AM 715 CEP

A AM 715 CEP of the European Pharmacopoeia monograph is often referred to as a AM 715 Certificate of Suitability (COS). The purpose of a AM 715 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AM 715 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AM 715 to their clients by showing that a AM 715 CEP has been issued for it. The manufacturer submits a AM 715 CEP (COS) as part of the market authorization procedure, and it takes on the role of a AM 715 CEP holder for the record. Additionally, the data presented in the AM 715 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AM 715 DMF.

A AM 715 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AM 715 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 AM 715 suppliers with CEP (COS) on PharmaCompass.

AM 715 WC

A AM 715 written confirmation (AM 715 WC) is an official document issued by a regulatory agency to a AM 715 manufacturer, verifying that the manufacturing facility of a AM 715 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AM 715 APIs or AM 715 finished pharmaceutical products to another nation, regulatory agencies frequently require a AM 715 WC (written confirmation) as part of the regulatory process.

click here to find a list of AM 715 suppliers with Written Confirmation (WC) on PharmaCompass.

AM 715 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 715 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for AM 715 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 715 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 715 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AM 715 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of AM 715 suppliers with NDC on PharmaCompass.

AM 715 GMP

AM 715 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 715 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 715 GMP manufacturer or AM 715 GMP API supplier for your needs.

AM 715 CoA

A AM 715 CoA (Certificate of Analysis) is a formal document that attests to AM 715's compliance with AM 715 specifications and serves as a tool for batch-level quality control.

AM 715 CoA mostly includes findings from lab analyses of a specific batch. For each AM 715 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 715 may be tested according to a variety of international standards, such as European Pharmacopoeia (AM 715 EP), AM 715 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AM 715 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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