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TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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






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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Accofil
Dosage Form : Solution For Injection/Infusion
Dosage Strength : 70ME/0.73ml
Packaging :
Approval Date : 28/02/2022
Application Number : 20210104000095
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Grastofil
Dosage Form : Solution For Injection/Infusion
Dosage Strength : 48ME/0.5ml
Packaging :
Approval Date : 18/10/2013
Application Number : 20120614000020
Regulatory Info : Deregistered
Registration Country : Sweden

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Neupogen
Dosage Form : Injectable Solution
Dosage Strength : 0.6MG
Packaging :
Approval Date : 2001-10-24
Application Number : 64314
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info :
Registration Country : Norway
Brand Name : Nivestim
Dosage Form : Injection/infusion fluid, resolution
Dosage Strength : 48 Mill IE/0.5 ml
Packaging : Finish filled syringe
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Nivestim
Dosage Form : Injectable And Perfusion Solution
Dosage Strength : 30MU
Packaging :
Approval Date : 2010-10-19
Application Number : 110631005
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Nivestim
Dosage Form : Injectable Or Infusion Solution
Dosage Strength : 48MU
Packaging :
Approval Date : 2010-10-19
Application Number : 110631008
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Ratiograstim
Dosage Form : Solution For Injection Or Perfusion
Dosage Strength : 48MU
Packaging :
Approval Date : 2008-09-25
Application Number : 08444006
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info :
Registration Country : Norway
Brand Name : Zarzio
Dosage Form : Injection/infusion fluid, resolution
Dosage Strength : 48 Mill E/0.5 ml
Packaging : Finish filled syringe with nålebeskytter
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway

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Regulatory Info :
Registration Country : Italy
Brand Name : Tagrast
Dosage Form : Filgrastim 30,000.000Iu 1 Unit Parenteral Use
Dosage Strength : 1 syringe 30,000,000 IU 0.5 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Filgrastim-Teva
Dosage Form : Solution For Injection
Dosage Strength : 30000000IU/0.5ml
Packaging :
Approval Date : 08/01/2010
Application Number : 60722
Regulatory Info : Allowed
Registration Country : Switzerland

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