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28-30 October, 2025
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11-14 October, 2025
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12-17 October, 2025
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INTERVIEW #SpeakPharma
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https://www.fiercepharma.com/manufacturing/new-woodstock-ceo-buschur-plots-growth-strategy-blow-fill-seal-cdmo
27 Nov 2024
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13 Feb 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217236
10 Jan 2023
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214463
11 May 2022
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https://www.contractpharma.com/contents/view_breaking-news/2022-05-11/neuvivo-begins-manufacture-of-als-treatment-np001/?widget=listSection
17 Jan 2022
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https://news.cision.com/oxcia-ab--publ-/r/oxcia-contracts-patheon-for-manufacturing-and-further-strengthens-the-organization,c3486875#:~:text=Oxcia%20contracts%20Patheon%20for%20manufacturing%20and%20further%20strengthens%20the%20organization,-Mon%2C%20Jan%2017&text=OXC%2D101%20is%20Oxcia's%20first,solid%20cancers%20or%20blood%20cancers.
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-21
Pay. Date : 2013-09-17
DMF Number : 25924
Submission : 2012-03-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16099
Submission : 2002-08-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28414
Submission : 2014-10-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9584
Submission : 1992-03-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9689
Submission : 1992-05-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5252
Submission : 1984-01-24
Status : Inactive
Type : II
CEP/COS
Certificate Numbers : R1-CEP 2011-060 - Rev 00
Status : Valid
Issue Date : 2018-06-13
Type : Chemical
Substance Number : 1777
CEP/COS
Certificate Numbers : R1-CEP 2004-084 - Rev 02
Status : Valid
Issue Date : 2016-12-15
Type : Chemical
Substance Number : 46
CEP/COS
Certificate Numbers : R1-CEP 2003-253 - Rev 02
Status : Valid
Issue Date : 2016-12-15
Type : Chemical
Substance Number : 626
CEP/COS
Certificate Numbers : R1-CEP 2003-117 - Rev 03
Status : Valid
Issue Date : 2016-12-15
Type : Chemical
Substance Number : 1255
Details:
TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the US maintains a supply of TPOXX under Project BioShield.
Lead Product(s): Tecovirimat,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Tpoxx
Study Phase: Approved FDFProduct Type: Miscellaneous
Recipient: SIGA Technologies
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 19, 2022
Lead Product(s) : Tecovirimat,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Recipient : SIGA Technologies
Deal Size : Inapplicable
Deal Type : Inapplicable
SIGA Receives Approval from the FDA for Intravenous (IV) Formulation of TPOXX® (tecovirimat)
Details : TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the US maintains a supply of TPOXX und...
Product Name : Tpoxx
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 19, 2022
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : CHLOROTRIANISENE
Dosage Strength : 12MG
Packaging :
Approval Date : 1982-01-01
Application Number : 84652
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : CLOFIBRATE
Dosage Strength : 500MG
Packaging :
Approval Date : 1992-03-20
Application Number : 73396
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : ETHCHLORVYNOL
Dosage Strength : 100MG
Packaging :
Approval Date : 1982-01-01
Application Number : 84463
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : ETHCHLORVYNOL
Dosage Strength : 200MG
Packaging :
Approval Date : 1982-01-01
Application Number : 84463
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : ETHCHLORVYNOL
Dosage Strength : 500MG
Packaging :
Approval Date : 1982-01-01
Application Number : 84463
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : ETHCHLORVYNOL
Dosage Strength : 750MG
Packaging :
Approval Date : 1982-01-01
Application Number : 84463
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : OTC
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : IBUPROFEN
Dosage Strength : EQ 200MG FREE ACID AND...
Packaging :
Approval Date : 2024-02-13
Application Number : 217236
Regulatory Info : OTC
Registration Country : USA
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Capsule
Brand Name : Ibuprofen Banner Pharmaca...
Dosage Strength : 200mg
Packaging :
Approval Date : 02/09/2005
Application Number : 20040607001899
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : OTC
Registration Country : USA
Dosage Form : CAPSULE;ORAL
Brand Name : NAPROXEN SODIUM
Dosage Strength : EQ 200MG BASE
Packaging :
Approval Date : 2023-01-10
Application Number : 214463
Regulatory Info : OTC
Registration Country : USA
Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Capsule
Brand Name : Naproxen Banner
Dosage Strength : 200mg
Packaging :
Approval Date : 10/04/2014
Application Number : 20120901000030
Regulatory Info : Deregistered
Registration Country : Sweden
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Patheon is a supplier offers 67 products (APIs, Excipients or Intermediates).
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