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USDMF
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Regulatory Info :
Registration Country : Italy
Brand Name : ALPHAGAN
Dosage Form : Eye Drops Solution
Dosage Strength : 0.20%
Packaging : 5 ML 0.2% - OPHTHALMIC USE SOLUTION
Approval Date :
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Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : COMBIGAN
Dosage Form : Eye Drops
Dosage Strength : 0.2% + 0.5%
Packaging : 5 ML 2 MG/ML + 5 MG/ML - OPHTHALMIC USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Brand Name : Alphagan
Dosage Form : Gt Opht
Dosage Strength : 0.10%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Alphagan
Dosage Form : Gt Opht
Dosage Strength : 0.20%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brimonidini tartras; Timololum
Brand Name : Combigan
Dosage Form : Gtt Opht
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brimonidini tartras; Timololum
Brand Name : Combigan
Dosage Form : Gtt Opht
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Alphagan
Dosage Form : EYE DROPS, SOLUTION
Dosage Strength : 0.2% (2 MG / ML)
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Several substances refer to content
Brand Name : Combigan
Dosage Form : EYE DROPS, SOLUTION
Dosage Strength : 2 MG / ML + 5 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Alphagan
Dosage Form : Brimonidine 0.2% 5Ml Solution Ophthalmic Use
Dosage Strength : EYE DROPS 5 ml 2 mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Alphagan
Dosage Form : Eye drops, resolution
Dosage Strength : 2 mg/ml
Packaging : Bottle of plastic with dropping tip
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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EUROAPI
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Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Ophthalmic Solution
Grade : Oral, Ophthalmic, Injectable, Topical
Application : Solubilizers
Excipient Details : Tyloxapol is used as a solubilizing, emulsifying and stabilizing agent in nebulizers, eye drops, injectables, oral syrups and topical dosage forms.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Tyloxapol
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PharmaCompass offers a list of Brimonidine Tartrate 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 Brimonidine Tartrate manufacturer or Brimonidine Tartrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Brimonidine Tartrate manufacturer or Brimonidine Tartrate supplier.
PharmaCompass also assists you with knowing the Brimonidine Tartrate API Price utilized in the formulation of products. Brimonidine Tartrate API Price is not always fixed or binding as the Brimonidine Tartrate Price is obtained through a variety of data sources. The Brimonidine Tartrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Brimonidine Tartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Brimonidine Tartrate, including repackagers and relabelers. The FDA regulates Brimonidine Tartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Brimonidine Tartrate 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 Brimonidine Tartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Brimonidine Tartrate supplier is an individual or a company that provides Brimonidine Tartrate active pharmaceutical ingredient (API) or Brimonidine Tartrate finished formulations upon request. The Brimonidine Tartrate suppliers may include Brimonidine Tartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Brimonidine Tartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Brimonidine Tartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Brimonidine Tartrate active pharmaceutical ingredient (API) in detail. Different forms of Brimonidine Tartrate DMFs exist exist since differing nations have different regulations, such as Brimonidine Tartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Brimonidine Tartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Brimonidine Tartrate USDMF includes data on Brimonidine Tartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Brimonidine Tartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Brimonidine Tartrate 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 Brimonidine Tartrate Drug Master File in Japan (Brimonidine Tartrate JDMF) empowers Brimonidine Tartrate 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 Brimonidine Tartrate JDMF during the approval evaluation for pharmaceutical products. At the time of Brimonidine Tartrate 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 Brimonidine Tartrate 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 Brimonidine Tartrate Drug Master File in Korea (Brimonidine Tartrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Brimonidine Tartrate. The MFDS reviews the Brimonidine Tartrate KDMF as part of the drug registration process and uses the information provided in the Brimonidine Tartrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Brimonidine Tartrate 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 Brimonidine Tartrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Brimonidine Tartrate suppliers with KDMF on PharmaCompass.
A Brimonidine Tartrate CEP of the European Pharmacopoeia monograph is often referred to as a Brimonidine Tartrate Certificate of Suitability (COS). The purpose of a Brimonidine Tartrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Brimonidine Tartrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Brimonidine Tartrate to their clients by showing that a Brimonidine Tartrate CEP has been issued for it. The manufacturer submits a Brimonidine Tartrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Brimonidine Tartrate CEP holder for the record. Additionally, the data presented in the Brimonidine Tartrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Brimonidine Tartrate DMF.
A Brimonidine Tartrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Brimonidine Tartrate 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 Brimonidine Tartrate suppliers with CEP (COS) on PharmaCompass.
A Brimonidine Tartrate written confirmation (Brimonidine Tartrate WC) is an official document issued by a regulatory agency to a Brimonidine Tartrate manufacturer, verifying that the manufacturing facility of a Brimonidine Tartrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Brimonidine Tartrate APIs or Brimonidine Tartrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Brimonidine Tartrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Brimonidine Tartrate 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 Brimonidine Tartrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Brimonidine Tartrate 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 Brimonidine Tartrate 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 Brimonidine Tartrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Brimonidine Tartrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Brimonidine Tartrate suppliers with NDC on PharmaCompass.
Brimonidine Tartrate 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 Brimonidine Tartrate 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 Brimonidine Tartrate GMP manufacturer or Brimonidine Tartrate GMP API supplier for your needs.
A Brimonidine Tartrate CoA (Certificate of Analysis) is a formal document that attests to Brimonidine Tartrate's compliance with Brimonidine Tartrate specifications and serves as a tool for batch-level quality control.
Brimonidine Tartrate CoA mostly includes findings from lab analyses of a specific batch. For each Brimonidine Tartrate 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.
Brimonidine Tartrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Brimonidine Tartrate EP), Brimonidine Tartrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Brimonidine Tartrate USP).
