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API SUPPLIERS
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USDMF
Axplora- The partner of choice for complex APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2024-07-18
Pay. Date : 2024-06-12
DMF Number : 35780
Submission : 2021-04-13
Status :
Type : II
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
GDUFA
DMF Review : Complete
Rev. Date : 2014-04-18
Pay. Date : 2014-04-11
DMF Number : 4423
Submission : 1982-02-03
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Registration Number : 218MF10387
Registrant's Address : 15 rue Traversie(')re 75012 Paris France
Initial Date of Registration : 2006-03-20
Latest Date of Registration : 2016-12-20
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Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...
Axplora- The partner of choice for complex APIs.
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
21-Desacetoxy Anecortave Oxediene
CAS Number : 34184-82-2
End Use API : Fluorometholone
About The Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfoli...
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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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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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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 Fluorometholon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluorometholon, including repackagers and relabelers. The FDA regulates Fluorometholon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluorometholon 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 Fluorometholon manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluorometholon supplier is an individual or a company that provides Fluorometholon active pharmaceutical ingredient (API) or Fluorometholon finished formulations upon request. The Fluorometholon suppliers may include Fluorometholon API manufacturers, exporters, distributors and traders.
click here to find a list of Fluorometholon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluorometholon DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluorometholon active pharmaceutical ingredient (API) in detail. Different forms of Fluorometholon DMFs exist exist since differing nations have different regulations, such as Fluorometholon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluorometholon DMF submitted to regulatory agencies in the US is known as a USDMF. Fluorometholon USDMF includes data on Fluorometholon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluorometholon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluorometholon 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 Fluorometholon Drug Master File in Japan (Fluorometholon JDMF) empowers Fluorometholon 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 Fluorometholon JDMF during the approval evaluation for pharmaceutical products. At the time of Fluorometholon 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 Fluorometholon 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 Fluorometholon Drug Master File in Korea (Fluorometholon KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fluorometholon. The MFDS reviews the Fluorometholon KDMF as part of the drug registration process and uses the information provided in the Fluorometholon KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fluorometholon 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 Fluorometholon API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fluorometholon 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 Fluorometholon as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fluorometholon 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 Fluorometholon 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 Fluorometholon and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fluorometholon NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fluorometholon suppliers with NDC on PharmaCompass.
Fluorometholon 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 Fluorometholon 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 Fluorometholon GMP manufacturer or Fluorometholon GMP API supplier for your needs.
A Fluorometholon CoA (Certificate of Analysis) is a formal document that attests to Fluorometholon's compliance with Fluorometholon specifications and serves as a tool for batch-level quality control.
Fluorometholon CoA mostly includes findings from lab analyses of a specific batch. For each Fluorometholon 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.
Fluorometholon may be tested according to a variety of international standards, such as European Pharmacopoeia (Fluorometholon EP), Fluorometholon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fluorometholon USP).
