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Digital content

07 Jan 2025
// FIERCE PHARMA
https://www.fiercepharma.com/manufacturing/new-woodstock-ceo-buschur-plots-growth-strategy-blow-fill-seal-cdmo

27 Nov 2024
// FDA

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
// CONTRACTPHARMA
https://www.contractpharma.com/contents/view_breaking-news/2022-05-11/neuvivo-begins-manufacture-of-als-treatment-np001/?widget=listSection

17 Jan 2022
// CISION
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.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2003-117 - Rev 03
Issue Date : 2016-12-15
Type : Chemical
Substance Number : 1255
Status : Valid
Registration Number : 227MF10212
Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria
Initial Date of Registration : 2015-08-18
Latest Date of Registration :
NDC Package Code : 45941-3051
Start Marketing Date : 1993-01-11
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2011-060 - Rev 00
Issue Date : 2018-06-13
Type : Chemical
Substance Number : 1777
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 304MF10064
Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria
Initial Date of Registration : 2022-04-06
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 306MF10020
Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria
Initial Date of Registration : 2024-01-30
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2003-253 - Rev 02
Issue Date : 2016-12-15
Type : Chemical
Substance Number : 626
Status : Valid
NDC Package Code : 45941-3053
Start Marketing Date : 2011-07-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2004-084 - Rev 02
Issue Date : 2016-12-15
Type : Chemical
Substance Number : 46
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 305MF10083
Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria
Initial Date of Registration : 2023-07-19
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 222MF10047
Registrant's Address : St. -Peter-Strasse 25, 4020 Linz / Austria
Initial Date of Registration : 2010-02-09
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-21
Pay. Date : 2013-09-17
DMF Number : 25924
Submission : 2012-03-30
Status : Inactive
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16099
Submission : 2002-08-15
Status : Inactive
Type : II

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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

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Registrant Name : Boryeong Co., Ltd.
Registration Date : 2022-04-25
Registration Number : 20220425-209-J-1277
Manufacturer Name : Patheon API Inc.
Manufacturer Address : 6173 East Old Marion Highway, Florence, South Carolina (SC) 29506, United States (USA...

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Registrant Name : SK Chemical Co., Ltd.
Registration Date : 2019-11-26
Registration Number : Su703-6-ND
Manufacturer Name : Patheon Austria GmbH & Co. KG@...
Manufacturer Address : St. Peter Strasse 25, 4020 Linz Austria@[Micronising Manufactory]Via Sottobisio 42a/c...

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Registrant Name : Roche Korea Co., Ltd.
Registration Date : 2022-04-26
Registration Number : 20220426-209-J-1279
Manufacturer Name : Patheon API Inc.
Manufacturer Address : 6173 East Old Marion Highway, Florence, South Carolina 29506-9330, United States

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Registrant Name : Bansen Co., Ltd.
Registration Date : 2021-11-30
Registration Number : 20211130-209-J-1094
Manufacturer Name : Patheon Austria GmbH & Co. KG
Manufacturer Address : St. Peter Strasse 25, 4020 Linz Austria

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Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2011-07-15
Registration Number : Su661-6-ND
Manufacturer Name : Patheon Austria GmbH & Co. KG
Manufacturer Address : St. Peter Strasse 25, 4020 Linz Austria

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Registrant Name : Bansen Co., Ltd.
Registration Date : 2021-12-03
Registration Number : 20211203-209-J-1169
Manufacturer Name : Patheon Austria GmbH & Co. KG
Manufacturer Address : St. Peter Strasse 25, 4020 Linz Austria

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Registrant Name : Korea BMS Pharmaceutical Co., Ltd.
Registration Date : 2023-02-23
Registration Number : Su342-20-ND
Manufacturer Name : Patheon API Manufacturing Inc....
Manufacturer Address : 309 Delaware Street, Greenville, SC 29605, USA@Hauptstrasse 171, 4416 Bubendorf, Swit...

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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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API & Drug Product Development
Excipients
Inspections and registrations
District Decision : No Action Indicated
Inspection End Date : 2017-08-11
City : High Point
State : NC
Country/Area : U.S.A
Zip : 27265-8144
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2017-08-11

District Decision : No Action Indicated
Inspection End Date : 2017-04-20
City : Greenville
State : NC
Country/Area : U.S.A
Zip : 27834-8628
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2017-04-20

District Decision : Voluntary Action Indicated
Inspection End Date : 2017-03-02
City : Cincinnati
State : OH
Country/Area : U.S.A
Zip : 45237-1625
District : CIN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-03-02

District Decision : Voluntary Action Indicated
Inspection End Date : 2015-09-03
City : Manati
State : PR
Country/Area : U.S.A
Zip : 674
District : SJN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-09-03

District Decision : No Action Indicated
Inspection End Date : 2015-02-13
City : Princeton
State : NJ
Country/Area : U.S.A
Zip : 8540
District : NWJ
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2015-02-13

District Decision : Voluntary Action Indicated
Inspection End Date : 2015-01-30
City : Mississauga
State :
Country/Area : Canada
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-01-30

District Decision : No Action Indicated
Inspection End Date : 2015-01-29
City : High Point
State : NC
Country/Area : U.S.A
Zip : 27265-8144
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2015-01-29

District Decision : No Action Indicated
Inspection End Date : 2015-01-28
City : Capua
State :
Country/Area : Italy
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2015-01-28

District Decision : No Action Indicated
Inspection End Date : 2014-11-26
City : Greenville
State : SC
Country/Area : U.S.A
Zip : 29605
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-11-26

District Decision : No Action Indicated
Inspection End Date : 2014-11-14
City : Groningen
State :
Country/Area : Netherlands
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-11-14

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Country : Netherlands
City/Region : AS Tilburg
Audit Date : 2024-11-19
Audit Type : On-Site
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
Patheon is a supplier offers 70 products (APIs, Excipients or Intermediates).
Find a price of Pyridostigmine bulk with CEP, JDMF offered by Patheon
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