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DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - 0.1%
USFDA APPLICATION NUMBER - 16851
DOSAGE - OINTMENT;OPHTHALMIC - 0.1%
USFDA APPLICATION NUMBER - 17760
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Nanjing Well Pharmaceutical
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ABOUT THIS PAGE
38
PharmaCompass offers a list of Fluorometholone 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 Fluorometholone manufacturer or Fluorometholone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fluorometholone manufacturer or Fluorometholone supplier.
PharmaCompass also assists you with knowing the Fluorometholone API Price utilized in the formulation of products. Fluorometholone API Price is not always fixed or binding as the Fluorometholone Price is obtained through a variety of data sources. The Fluorometholone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fluor Op manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluor Op, including repackagers and relabelers. The FDA regulates Fluor Op manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluor Op 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 Fluor Op manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluor Op supplier is an individual or a company that provides Fluor Op active pharmaceutical ingredient (API) or Fluor Op finished formulations upon request. The Fluor Op suppliers may include Fluor Op API manufacturers, exporters, distributors and traders.
click here to find a list of Fluor Op suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluor Op DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluor Op active pharmaceutical ingredient (API) in detail. Different forms of Fluor Op DMFs exist exist since differing nations have different regulations, such as Fluor Op USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluor Op DMF submitted to regulatory agencies in the US is known as a USDMF. Fluor Op USDMF includes data on Fluor Op's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluor Op USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluor Op 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 Fluor Op Drug Master File in Japan (Fluor Op JDMF) empowers Fluor Op 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 Fluor Op JDMF during the approval evaluation for pharmaceutical products. At the time of Fluor Op 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 Fluor Op 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 Fluor Op Drug Master File in Korea (Fluor Op KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fluor Op. The MFDS reviews the Fluor Op KDMF as part of the drug registration process and uses the information provided in the Fluor Op KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fluor Op 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 Fluor Op API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fluor Op suppliers with KDMF 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 Fluor Op as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fluor Op 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 Fluor Op 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 Fluor Op and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fluor Op NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fluor Op suppliers with NDC on PharmaCompass.
Fluor Op 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 Fluor Op 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 Fluor Op GMP manufacturer or Fluor Op GMP API supplier for your needs.
A Fluor Op CoA (Certificate of Analysis) is a formal document that attests to Fluor Op's compliance with Fluor Op specifications and serves as a tool for batch-level quality control.
Fluor Op CoA mostly includes findings from lab analyses of a specific batch. For each Fluor Op 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.
Fluor Op may be tested according to a variety of international standards, such as European Pharmacopoeia (Fluor Op EP), Fluor Op JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fluor Op USP).
