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API SUPPLIERS
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
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JDMF
NDC
KDMF
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
CEP/COS
NDC
KDMF
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : Complete
Rev. Date : 2012-10-26
Pay. Date : 2012-12-19
DMF Number : 15585
Submission : 2001-08-15
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-23
DMF Number : 15601
Submission : 2001-08-27
Status :
Type : II
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Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Certificate Number : CEP 2014-331 - Rev 03
Status : Valid
Issue Date : 2024-03-06
Type : Chemical
Substance Number : 2760
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Certificate Number : R1-CEP 2013-353 - Rev 00
Status : Valid
Issue Date : 2019-04-24
Type : Chemical
Substance Number : 2760
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Registration Number : 302MF10029
Registrant's Address : Na vlcinci 16/3 Klasterni Hradisko 779 00 Olomouc Czech Republic
Initial Date of Registration : 2020-02-13
Latest Date of Registration : 2020-02-13
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Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
About the Company : Farmak, A.S. is a privately held chemical and pharmaceutical company based in the Czech Republic. It specializes in researching, developing and producing active pharmaceutical ingr...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Act...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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API Imports and Exports
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Drugs in Development
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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 :
Application Number :
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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Digital Content
DATA COMPILATION #PharmaFlow
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Global Sales Information
US Medicaid Prescriptions
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RX/OTC/DISCN : RX
Dosage Form : SOLUTION/DROPS;OPHTHALMIC
Dosage Strength : 0.15%
Price Per Pack :
Published in :
Country : USA
RX/OTC/DISCN : RX
RX/OTC/DISCN : Class A
Dosage Form : Brimonidine 0.2% 5Ml Solution Op...
Dosage Strength : EYE DROPS 5 ml 2 mg/ml
Price Per Pack (Euro) : 12.54
Published in :
Country : Italy
RX/OTC/DISCN : Class A
RX/OTC/DISCN :
Brimonidine Tartrate; Timolol Maleate
Dosage Form : Eye Drops
Dosage Strength : 0.2% + 0.5%
Price Per Pack (Euro) : 13.83
Published in :
Country : Italy
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Eye Drops Solution
Dosage Strength : 0.20%
Price Per Pack (Euro) : 12.54
Published in :
Country : Italy
RX/OTC/DISCN :
RX/OTC/DISCN : Class B
Dosage Form : Gt Opht
Dosage Strength : 0.10%
Price Per Pack (Euro) : 22.15
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
RX/OTC/DISCN : Class B
Dosage Form : Gt Opht
Dosage Strength : 0.20%
Price Per Pack (Euro) : 8.67
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
RX/OTC/DISCN : Class B
Brimonidine Tartrate; Timolol Maleate
Dosage Form : Gtt Opht
Dosage Strength :
Price Per Pack (Euro) : 12.71
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
RX/OTC/DISCN : Class B
Brimonidine Tartrate; Timolol Maleate
Dosage Form : Gtt Opht
Dosage Strength :
Price Per Pack (Euro) : 36.22
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
RX/OTC/DISCN :
Dosage Form : Eye drops, resolution
Dosage Strength : 2 mg/ml
Price Per Pack (Euro) : 12.529
Published in :
Country : Norway
RX/OTC/DISCN :
RX/OTC/DISCN :
Dosage Form : Eye drops, resolution
Dosage Strength : 2 mg/ml
Price Per Pack (Euro) : 30.723
Published in :
Country : Norway
RX/OTC/DISCN :
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US Patents
Patent Expiration Date : 2024-03-02
US Patent Number : 8858961*PED
Drug Substance Claim :
Drug Product Claim :
Application Number : 21770
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2024-03-02
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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).
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