Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
DRUG PRODUCT COMPOSITIONS
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
US Medicaid
NA
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25947
Submission : 2012-05-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24988
Submission : 2011-05-27
Status : Inactive
Type : II
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
---|
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Regulatory Info : Prescription
Registration Country : Canada
Brand Name : NEUPOGEN
Dosage Form : SOLUTION
Dosage Strength : 300MCG/ML
Packaging : 1.0/1.6ML
Approval Date :
Application Number : 1968017
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : NEUPOGEN
Dosage Form : SOLUTION
Dosage Strength : 600MCG/ML
Packaging : 0.5ML
Approval Date :
Application Number : 2420104
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : NEUPOGEN
Dosage Form : SOLUTION
Dosage Strength : 600MCG/ML
Packaging : 10
Approval Date :
Application Number : 2420112
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : GRASTOFIL
Dosage Form : SOLUTION
Dosage Strength : 300MCG/0.5ML
Packaging : 0.5ML
Approval Date :
Application Number : 2441489
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : GRASTOFIL
Dosage Form : SOLUTION
Dosage Strength : 480MCG/0.8ML
Packaging : 0.8ML
Approval Date :
Application Number : 2454548
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : NIVESTYM
Dosage Form : SOLUTION
Dosage Strength : 300MCG/0.5ML
Packaging :
Approval Date :
Application Number : 2485575
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : NIVESTYM
Dosage Form : SOLUTION
Dosage Strength : 480MCG/0.8ML
Packaging :
Approval Date :
Application Number : 2485583
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : NIVESTYM
Dosage Form : SOLUTION
Dosage Strength : 300MCG/ML
Packaging :
Approval Date :
Application Number : 2485591
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : NIVESTYM
Dosage Form : SOLUTION
Dosage Strength : 480MCG/1.6ML
Packaging :
Approval Date :
Application Number : 2485656
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : NYPOZI
Dosage Form : SOLUTION
Dosage Strength : 300MCG/0.5ML
Packaging :
Approval Date :
Application Number : 2520990
Regulatory Info : Prescription
Registration Country : Canada
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Related Excipient Companies
Dosage Form : Syrup
Grade : Not Available
Application : Taste Masking
Pharmacopoeia Ref : Not Available
Technical Specs : Pharma Grade/Food Grade
Ingredient(s) : Sorbitol
Excipients by Applications
Dosage Form : Capsule, Tablet, Dry Syrup
Grade : Oral
Category : Co-Processed Excipients, Direct Compression, Solubilizers
Application : Co-Processed Excipients, Direct Compression, Solubilizers
Excipient Details : Solubilizer
Pharmacopoeia Ref : Not Available
Technical Specs : Solubilizer in powder form; EXCiPACT
Ingredient(s) : Polysorbate 80
Grade : Oral
Category : API Stability Enhancers, Direct Compression, Solubilizers
Application : API Stability Enhancers, Direct Compression, Solubilizers
Excipient Details : Polysorbate 80 in dry powder form, a solubilizing agent acts as a surfactant and increases the solubility of various oral dosage forms.
Pharmacopoeia Ref : USP-NF, EP, JP & having US DMF
Technical Specs : Solubilizer in powder form, used in directly compressible dosage ...
Ingredient(s) : Magnesium aluminium silicate Excipient
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel
Grade : Topical
Category : Rheology Modifiers, Thickeners and Stabilizers, Topical
Application : Rheology Modifiers, Thickeners and Stabilizers, Topical
Excipient Details : Thickener, Stabilizer / Emulsifier, Texturizing Agent
Pharmacopoeia Ref : IID
Technical Specs : EXCiPACT
Ingredient(s) : Acrylamide / Sodium Acryloyldimethyl Taurate Copolymer Isohexadecane and Polysorbate 80
Dosage Form : Cream / Lotion / Ointment, Emulsion
Grade : Topical
Category : Emulsifying Agents, Rheology Modifiers, Thickeners and Stabilizers, Topical
Application : Emulsifying Agents, Rheology Modifiers, Thickeners and Stabilizers, Topical
Excipient Details : Thickener, Emulsifier, Stabilizer, Texturizing agent, pH Independent & Non Thixotropic polymer for Topical Range (Skin,Vaginal & Anal mucosa)
Pharmacopoeia Ref : In house having US DMF Type IV...
Technical Specs : Ready to use liquid polymer for topical applications (Gel / Cream...
Ingredient(s) : Hydroxyethyl Acrylate
Global Sales Information
Dosage Form : Filgrastim 12,000.000Iu 0.2Ml 1 ...
Dosage Strength : 1 syringe SC EV 12.000.000 IU 0.2 ml
Price Per Pack (Euro) : 38.96
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Dosage Form : Filgrastim 30,000.000Iu 1 Unit P...
Dosage Strength : 1 syringe SC EV 30 MU 0.5 ml + safety need...
Price Per Pack (Euro) : 95.18
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Dosage Form : Filgrastim 30,000.000Iu 1 Unit P...
Dosage Strength : 1 vial SC EV 30,000,000 IU 1 ml
Price Per Pack (Euro) : 127.95
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Dosage Form : Filgrastim 30,000.000Iu 1 Unit P...
Dosage Strength : 1 syringe 30,000,000 IU 0.5 ml
Price Per Pack (Euro) : 127.95
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Dosage Form : Filgrastim 30,000.000Iu 1 Unit P...
Dosage Strength : 1 syringe SC EV 30,000,000 IU 0.5 ml
Price Per Pack (Euro) : 95.18
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Dosage Form : Filgrastim 30,000.000Iu 1 Unit P...
Dosage Strength : 1 syringe 30,000,000 IU 0.5 ml
Price Per Pack (Euro) : 99.8
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Dosage Form : Filgrastim 30,000.000Iu 1 Unit P...
Dosage Strength : 1 syringe 30,000,000 IU 0.5 ml
Price Per Pack (Euro) : 95.97
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Dosage Form : Filgrastim 30,000.000Iu 5 Units ...
Dosage Strength : 5 Syringes 30 MU 0.5 ml
Price Per Pack (Euro) : 479.85
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Dosage Form : Filgrastim 48,000.000Iu 1 Unit P...
Dosage Strength : 1 syringe SC EV 48.000.000 IU 0.5 ml
Price Per Pack (Euro) : 147.99
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Dosage Form : Filgrastim 48,000.000Iu 1 Unit P...
Dosage Strength : 1 syringe 48.000.000 IU 0.5 ml
Price Per Pack (Euro) : 153.53
Published in :
Country : Italy
RX/OTC/DISCN : Class A
Main Therapeutic Indication : Hematology
Currency : USD
2020 Revenue in Millions : 225
2019 Revenue in Millions : 264
Growth (%) : -15
Main Therapeutic Indication : Hematology
Currency : USD
2020 Revenue in Millions : 58
2019 Revenue in Millions : 61
Growth (%) : -5
Main Therapeutic Indication : Hematology
Currency : USD
2021 Revenue in Millions : 168
2020 Revenue in Millions : 225
Growth (%) : -25
Main Therapeutic Indication : Hematology
Currency : USD
2021 Revenue in Millions : 53
2020 Revenue in Millions : 58
Growth (%) : 3
Main Therapeutic Indication : Hematology
Currency : USD
2022 Revenue in Millions : 62
2021 Revenue in Millions : 53
Growth (%) : 17
Main Therapeutic Indication : Hematology
Currency : USD
2022 Revenue in Millions : 144
2021 Revenue in Millions : 168
Growth (%) : -14
Main Therapeutic Indication : Hematology
Currency : USD
2023 Revenue in Millions : 47
2022 Revenue in Millions : 62
Growth (%) : -16
Main Therapeutic Indication : Blood Related Disorders
Currency : USD
2015 Revenue in Millions : 1,159
2014 Revenue in Millions : 1,049
Growth (%) : -9%
Main Therapeutic Indication : Blood Disorders
Currency : USD
2017 Revenue in Millions : 549
2016 Revenue in Millions : 765
Growth (%) : -28
Main Therapeutic Indication : Blood Disorders
Currency : USD
2018 Revenue in Millions : 365
2017 Revenue in Millions : 549
Growth (%) : -34%
Market Place
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