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