Synopsis
Synopsis
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CEP/COS
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
Annual Reports
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
Molecular Weight | 292.5 g/mol |
---|---|
Molecular Formula | C10H8Cl3N3O |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 1 |
Rotatable Bond Count | 0 |
Exact Mass | 290.973295 g/mol |
Monoisotopic Mass | 290.973295 g/mol |
Topological Polar Surface Area | 44.7 A^2 |
Heavy Atom Count | 17 |
Formal Charge | 0 |
Complexity | 360 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 4 | |
---|---|
Drug Name | Agrylin |
PubMed Health | Anagrelide (By mouth) |
Drug Classes | Platelet Reducing Agent |
Drug Label | Name: AGRYLIN (anagrelide hydrochloride)Dosage Form:0.5 mg capsules for oral administrationActive Ingredient:AGRYLIN Capsules contain 0.5 mg of anagrelide base (as anagrelide hydrochloride).Inactive Ingredients:Anhydrous Lactose NF, Crospov... |
Active Ingredient | Anagrelide hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | eq 0.5mg base |
Market Status | Prescription |
Company | Shire |
2 of 4 | |
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Drug Name | Anagrelide hydrochloride |
Drug Label | Anagrelide hydrochloride is an off white powder that is very slightly soluble in water and sparingly soluble in dimethyl sulfoxide and in dimethylformamide. Anagrelide hydrochloride is a platelet-reducing agent with a chemical name of 6,7-dichloro-1,... |
Active Ingredient | Anagrelide hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | eq 0.5mg base; eq 1mg base |
Market Status | Prescription |
Company | Mylan Pharms; Ivax Sub Teva Pharms; Mylan; Impax Labs; Barr |
3 of 4 | |
---|---|
Drug Name | Agrylin |
PubMed Health | Anagrelide (By mouth) |
Drug Classes | Platelet Reducing Agent |
Drug Label | Name: AGRYLIN (anagrelide hydrochloride)Dosage Form:0.5 mg capsules for oral administrationActive Ingredient:AGRYLIN Capsules contain 0.5 mg of anagrelide base (as anagrelide hydrochloride).Inactive Ingredients:Anhydrous Lactose NF, Crospov... |
Active Ingredient | Anagrelide hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | eq 0.5mg base |
Market Status | Prescription |
Company | Shire |
4 of 4 | |
---|---|
Drug Name | Anagrelide hydrochloride |
Drug Label | Anagrelide hydrochloride is an off white powder that is very slightly soluble in water and sparingly soluble in dimethyl sulfoxide and in dimethylformamide. Anagrelide hydrochloride is a platelet-reducing agent with a chemical name of 6,7-dichloro-1,... |
Active Ingredient | Anagrelide hydrochloride |
Dosage Form | Capsule |
Route | Oral |
Strength | eq 0.5mg base; eq 1mg base |
Market Status | Prescription |
Company | Mylan Pharms; Ivax Sub Teva Pharms; Mylan; Impax Labs; Barr |
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
Undisclosed
Lead Product(s): Anagrelide Hydrochloride,Inapplicable
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 27, 2017
Lead Product(s) : Anagrelide Hydrochloride,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Anagre Cap. in Patients With High-Risk Essential Thrombocythemia
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
July 27, 2017
Details:
Undisclosed
Lead Product(s): Anagrelide Hydrochloride,Inapplicable
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 29, 2014
Lead Product(s) : Anagrelide Hydrochloride,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
April 29, 2014
Details:
Undisclosed
Lead Product(s): Anagrelide Hydrochloride,Inapplicable
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 04, 2014
Lead Product(s) : Anagrelide Hydrochloride,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Anagrelide Retard in Essential Thrombocythemia
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 04, 2014
Details:
Undisclosed
Lead Product(s): Anagrelide Hydrochloride,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 13, 2012
Lead Product(s) : Anagrelide Hydrochloride,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 13, 2012
Details:
Undisclosed
Lead Product(s): Anagrelide Hydrochloride,Inapplicable
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 09, 2011
Lead Product(s) : Anagrelide Hydrochloride,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 09, 2011
Details:
Undisclosed
Lead Product(s): Anagrelide Hydrochloride,Inapplicable
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 29, 2010
Lead Product(s) : Anagrelide Hydrochloride,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 29, 2010
Details:
Undisclosed
Lead Product(s): Anagrelide Hydrochloride,Inapplicable
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 05, 2010
Lead Product(s) : Anagrelide Hydrochloride,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 05, 2010
Details:
Undisclosed
Lead Product(s): Anagrelide Hydrochloride,Inapplicable
Therapeutic Area: Hematology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 09, 2010
Lead Product(s) : Anagrelide Hydrochloride,Inapplicable
Therapeutic Area : Hematology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 09, 2010
Regulatory Info :
Registration Country : Italy
Brand Name : ANAGRELIDE ACCORD
Dosage Form : Hard Capsules
Dosage Strength : 0.5 mg
Packaging : 100 UNITS 0.5 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Brand Name : Anagrelid Nordic
Dosage Form : Tabl
Dosage Strength : 0.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Anagrelid Nordic
Dosage Form : Tabl
Dosage Strength : 1mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Anagrelide Nordic
Dosage Form : Tabl
Dosage Strength : 0.75mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Thromboreductin
Dosage Form : Kaps
Dosage Strength : 0.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Sweden
Brand Name : Xagrid
Dosage Form : HARD CAPSULES
Dosage Strength : 0.5 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Xagrid
Dosage Form : Capsule, hard
Dosage Strength : 0.5 mg
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Brand Name : XAGRID
Dosage Form : Hard Capsule For Oral Use
Dosage Strength : 0.5 mg
Packaging : 100 UNITS 0.5 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Brand Name : Xagrid
Dosage Form : Caps
Dosage Strength : 0.5mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Brand Name : ANAGRELIDE TEVA
Dosage Form : Hard Capsules
Dosage Strength : 0.5 mg
Packaging : 100 UNITS 0.5 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Turkey
Brand Name :
Dosage Form : Capsule
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Turkey
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 0.5MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Turkey
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 0.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Capsule
Dosage Strength : 0.5MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Related Excipient Companies
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX ...
Application : Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
Dosage Form : Tablet
Grade : Oral
Excipients by Applications
Global Sales Information
Market Place
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Anagrelide Hydrochloride 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 Anagrelide Hydrochloride manufacturer or Anagrelide Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Anagrelide Hydrochloride manufacturer or Anagrelide Hydrochloride supplier.
PharmaCompass also assists you with knowing the Anagrelide Hydrochloride API Price utilized in the formulation of products. Anagrelide Hydrochloride API Price is not always fixed or binding as the Anagrelide Hydrochloride Price is obtained through a variety of data sources. The Anagrelide Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Agrylin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Agrylin, including repackagers and relabelers. The FDA regulates Agrylin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Agrylin 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 Agrylin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Agrylin supplier is an individual or a company that provides Agrylin active pharmaceutical ingredient (API) or Agrylin finished formulations upon request. The Agrylin suppliers may include Agrylin API manufacturers, exporters, distributors and traders.
click here to find a list of Agrylin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Agrylin DMF (Drug Master File) is a document detailing the whole manufacturing process of Agrylin active pharmaceutical ingredient (API) in detail. Different forms of Agrylin DMFs exist exist since differing nations have different regulations, such as Agrylin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Agrylin DMF submitted to regulatory agencies in the US is known as a USDMF. Agrylin USDMF includes data on Agrylin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Agrylin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Agrylin 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 Agrylin Drug Master File in Japan (Agrylin JDMF) empowers Agrylin 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 Agrylin JDMF during the approval evaluation for pharmaceutical products. At the time of Agrylin 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 Agrylin 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 Agrylin Drug Master File in Korea (Agrylin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Agrylin. The MFDS reviews the Agrylin KDMF as part of the drug registration process and uses the information provided in the Agrylin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Agrylin 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 Agrylin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Agrylin suppliers with KDMF on PharmaCompass.
A Agrylin written confirmation (Agrylin WC) is an official document issued by a regulatory agency to a Agrylin manufacturer, verifying that the manufacturing facility of a Agrylin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Agrylin APIs or Agrylin finished pharmaceutical products to another nation, regulatory agencies frequently require a Agrylin WC (written confirmation) as part of the regulatory process.
click here to find a list of Agrylin 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 Agrylin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Agrylin 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 Agrylin 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 Agrylin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Agrylin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Agrylin suppliers with NDC on PharmaCompass.
Agrylin 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 Agrylin 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 Agrylin GMP manufacturer or Agrylin GMP API supplier for your needs.
A Agrylin CoA (Certificate of Analysis) is a formal document that attests to Agrylin's compliance with Agrylin specifications and serves as a tool for batch-level quality control.
Agrylin CoA mostly includes findings from lab analyses of a specific batch. For each Agrylin 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.
Agrylin may be tested according to a variety of international standards, such as European Pharmacopoeia (Agrylin EP), Agrylin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Agrylin USP).