Synopsis
Synopsis
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USDMF
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CEP/COS
0
JDMF
0
EU WC
0
NDC API
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VMF
0
Listed Suppliers
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EDQM
0
USP
0
JP
0
Others
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Europe
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
US Medicaid
NA
Annual Reports
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Regulatory FDF Prices
NA
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API
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FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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News #PharmaBuzz
1. Q409935
| Molecular Weight | 536.5 g/mol |
|---|---|
| Molecular Formula | C20H40N3NaO10P |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 22 |
| Exact Mass | 536.23490076 g/mol |
| Monoisotopic Mass | 536.23490076 g/mol |
| Topological Polar Surface Area | 171 Ų |
| Heavy Atom Count | 35 |
| Formal Charge | 0 |
| Complexity | 623 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Macugen |
| PubMed Health | Pegaptanib (Injection) |
| Drug Classes | Ophthalmologic Agent |
| Active Ingredient | Pegaptanib sodium |
| Dosage Form | Injectable |
| Route | Intravitreal |
| Strength | eq 0.3mg acid/0.09ml |
| Market Status | Prescription |
| Company | Valeant Pharms |
| 2 of 2 | |
|---|---|
| Drug Name | Macugen |
| PubMed Health | Pegaptanib (Injection) |
| Drug Classes | Ophthalmologic Agent |
| Active Ingredient | Pegaptanib sodium |
| Dosage Form | Injectable |
| Route | Intravitreal |
| Strength | eq 0.3mg acid/0.09ml |
| Market Status | Prescription |
| Company | Valeant Pharms |
API SUPPLIERS
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registrant Name : Pfizer Korea
Registration Date : 2006-10-30
Registration Number : Su189-3-ND
Manufacturer Name : Roaylo Chemicals Inc
Manufacturer Address : 8045 ArgyII Road, Edmonton, Alberta, Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
KDMF
Registrant Name : Pfizer Korea
Registration Date : 2006-10-30
Registration Number : Su189-3-ND
Manufacturer Name : Roaylo Chemicals Inc
Manufacturer Address : 8045 ArgyII Road, Edmonton, Alberta, Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Details:
Pegaptanib Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Macular Degeneration.
Lead Product(s): Macugen,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 09, 2012
Lead Product(s) : Macugen,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Extension Study to Gather Data on Effect of Macugen on the Corneal Endothelium
Details : Pegaptanib Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Macular Degeneration.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 09, 2012
Details:
Pegaptanib Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Macular Edema.
Lead Product(s): Macugen,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Miscellaneous
Sponsor: Eyetech Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 07, 2011
Lead Product(s) : Macugen,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Eyetech Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Pegaptanib Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Macular Edema.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 07, 2011
Details:
Macugen (Pegaptanib Sodium) is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetic Retinopathy.
Lead Product(s): Macugen,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Macugen
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Pfizer Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 06, 2011
Lead Product(s) : Macugen,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Macugen for Proliferative Diabetic Retinopathy Study With Extended Dosing (M-PDRS ED)
Details : Macugen (Pegaptanib Sodium) is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Diabetic Retinopathy.
Product Name : Macugen
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 06, 2011
Details:
Pegaptanib Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Macular Edema.
Lead Product(s): Macugen,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 26, 2010
Lead Product(s) : Macugen,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Pegaptanib Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Macular Edema.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 26, 2010
Details:
Pegaptanib Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Macular Edema.
Lead Product(s): Macugen,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Pfizer Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 04, 2010
Lead Product(s) : Macugen,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Pfizer Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Intravitreal Macugen for Ischaemic Diabetic Macular Oedema
Details : Pegaptanib Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Macular Edema.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 04, 2010
Details:
Pegaptanib Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Macular Edema.
Lead Product(s): Macugen,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 08, 2010
Lead Product(s) : Macugen,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Pegaptanib Sodium is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Macular Edema.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 08, 2010
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MACUGEN
Dosage Form : INJECTABLE;INTRAVITREAL
Dosage Strength : EQ 0.3MG ACID/0.09ML
Packaging :
Approval Date : 2004-12-17
Application Number : 21756
Regulatory Info : DISCN
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : Yes
TE Code :
Brand Name : MACUGEN
Dosage Form : INJECTABLE;INTRAVITREAL
Dosage Strength : EQ 0.3MG ACID/0.09ML
Approval Date : 2004-12-17
Application Number : 21756
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
15
PharmaCompass offers a list of Macugen API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Macugen manufacturer or Macugen supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Macugen manufacturer or Macugen supplier.
A Macugen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Macugen, including repackagers and relabelers. The FDA regulates Macugen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Macugen API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Macugen supplier is an individual or a company that provides Macugen active pharmaceutical ingredient (API) or Macugen finished formulations upon request. The Macugen suppliers may include Macugen API manufacturers, exporters, distributors and traders.
click here to find a list of Macugen suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information 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 Macugen Drug Master File in Korea (Macugen KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Macugen. The MFDS reviews the Macugen KDMF as part of the drug registration process and uses the information provided in the Macugen KDMF to evaluate the safety and efficacy of the drug.
After submitting a Macugen 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 Macugen API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Macugen suppliers with KDMF on PharmaCompass.
Macugen 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 Macugen GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Macugen GMP manufacturer or Macugen GMP API supplier for your needs.
A Macugen CoA (Certificate of Analysis) is a formal document that attests to Macugen's compliance with Macugen specifications and serves as a tool for batch-level quality control.
Macugen CoA mostly includes findings from lab analyses of a specific batch. For each Macugen 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.
Macugen may be tested according to a variety of international standards, such as European Pharmacopoeia (Macugen EP), Macugen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Macugen USP).
