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USDMF
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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.4%;0.2...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.4%;0.25%
USFDA APPLICATION NUMBER - 208582
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.4%;0.3...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.4%;0.3%
USFDA APPLICATION NUMBER - 211039
Related Excipient Companies
Faran Shimi Pharmaceutical
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ABOUT THIS PAGE
43
PharmaCompass offers a list of Fluorescein 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 Fluorescein manufacturer or Fluorescein supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fluorescein manufacturer or Fluorescein supplier.
PharmaCompass also assists you with knowing the Fluorescein API Price utilized in the formulation of products. Fluorescein API Price is not always fixed or binding as the Fluorescein Price is obtained through a variety of data sources. The Fluorescein Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fluorescein manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluorescein, including repackagers and relabelers. The FDA regulates Fluorescein manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluorescein 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 Fluorescein manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluorescein supplier is an individual or a company that provides Fluorescein active pharmaceutical ingredient (API) or Fluorescein finished formulations upon request. The Fluorescein suppliers may include Fluorescein API manufacturers, exporters, distributors and traders.
click here to find a list of Fluorescein suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluorescein DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluorescein active pharmaceutical ingredient (API) in detail. Different forms of Fluorescein DMFs exist exist since differing nations have different regulations, such as Fluorescein USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluorescein DMF submitted to regulatory agencies in the US is known as a USDMF. Fluorescein USDMF includes data on Fluorescein's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluorescein USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluorescein suppliers with USDMF on PharmaCompass.
A Fluorescein CEP of the European Pharmacopoeia monograph is often referred to as a Fluorescein Certificate of Suitability (COS). The purpose of a Fluorescein CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Fluorescein EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Fluorescein to their clients by showing that a Fluorescein CEP has been issued for it. The manufacturer submits a Fluorescein CEP (COS) as part of the market authorization procedure, and it takes on the role of a Fluorescein CEP holder for the record. Additionally, the data presented in the Fluorescein CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Fluorescein DMF.
A Fluorescein CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Fluorescein 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 Fluorescein suppliers with CEP (COS) 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 Fluorescein as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fluorescein 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 Fluorescein 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 Fluorescein and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fluorescein NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fluorescein suppliers with NDC on PharmaCompass.
Fluorescein 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 Fluorescein 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 Fluorescein GMP manufacturer or Fluorescein GMP API supplier for your needs.
A Fluorescein CoA (Certificate of Analysis) is a formal document that attests to Fluorescein's compliance with Fluorescein specifications and serves as a tool for batch-level quality control.
Fluorescein CoA mostly includes findings from lab analyses of a specific batch. For each Fluorescein 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.
Fluorescein may be tested according to a variety of international standards, such as European Pharmacopoeia (Fluorescein EP), Fluorescein JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fluorescein USP).
