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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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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 FML Liquifilm manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of FML Liquifilm, including repackagers and relabelers. The FDA regulates FML Liquifilm manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. FML Liquifilm 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 FML Liquifilm manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A FML Liquifilm supplier is an individual or a company that provides FML Liquifilm active pharmaceutical ingredient (API) or FML Liquifilm finished formulations upon request. The FML Liquifilm suppliers may include FML Liquifilm API manufacturers, exporters, distributors and traders.
click here to find a list of FML Liquifilm suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A FML Liquifilm DMF (Drug Master File) is a document detailing the whole manufacturing process of FML Liquifilm active pharmaceutical ingredient (API) in detail. Different forms of FML Liquifilm DMFs exist exist since differing nations have different regulations, such as FML Liquifilm USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A FML Liquifilm DMF submitted to regulatory agencies in the US is known as a USDMF. FML Liquifilm USDMF includes data on FML Liquifilm's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The FML Liquifilm USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of FML Liquifilm 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 FML Liquifilm Drug Master File in Japan (FML Liquifilm JDMF) empowers FML Liquifilm 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 FML Liquifilm JDMF during the approval evaluation for pharmaceutical products. At the time of FML Liquifilm 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 FML Liquifilm 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 FML Liquifilm Drug Master File in Korea (FML Liquifilm KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of FML Liquifilm. The MFDS reviews the FML Liquifilm KDMF as part of the drug registration process and uses the information provided in the FML Liquifilm KDMF to evaluate the safety and efficacy of the drug.
After submitting a FML Liquifilm 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 FML Liquifilm API can apply through the Korea Drug Master File (KDMF).
click here to find a list of FML Liquifilm 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 FML Liquifilm as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for FML Liquifilm 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 FML Liquifilm 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 FML Liquifilm and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a FML Liquifilm NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of FML Liquifilm suppliers with NDC on PharmaCompass.
FML Liquifilm 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 FML Liquifilm 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 FML Liquifilm GMP manufacturer or FML Liquifilm GMP API supplier for your needs.
A FML Liquifilm CoA (Certificate of Analysis) is a formal document that attests to FML Liquifilm's compliance with FML Liquifilm specifications and serves as a tool for batch-level quality control.
FML Liquifilm CoA mostly includes findings from lab analyses of a specific batch. For each FML Liquifilm 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.
FML Liquifilm may be tested according to a variety of international standards, such as European Pharmacopoeia (FML Liquifilm EP), FML Liquifilm JP (Japanese Pharmacopeia) and the US Pharmacopoeia (FML Liquifilm USP).
