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22-24 April, 2025
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22-25 April, 2025
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/our-unmatched-efficiency-and-track-record-of-faster-dmf-filings-give-our-customers-a-critical-competitive-advantage
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22 Apr 2025
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https://www.businesswire.com/news/home/20250422295853/en/ConcertAI-Announces-Strategic-Agreement-with-Bayer-to-Accelerate-Clinical-Development-in-Precision-Oncology
18 Apr 2025
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https://www.reuters.com/business/healthcare-pharmaceuticals/bayer-ceo-targeting-us-state-regulation-stem-glyphosate-costs-2025-04-17/
16 Apr 2025
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10 Apr 2025
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https://www.businesswire.com/news/home/20250409395229/en/U.S.-FDA-Grants-Full-Approval-of-VITRAKVI-larotrectinib-for-Adult-and-Pediatric-Patients-with-NTRK-Gene-Fusion-Positive-Solid-Tumors
04 Apr 2025
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https://www.businesswire.com/news/home/20250404109983/en/Bayer-announces-filing-of-petition-to-U.S.-Supreme-Court-for-review-of-Durnell-Roundup-case
04 Apr 2025
// REUTERS
https://www.reuters.com/sustainability/boards-policy-regulation/bayer-renews-bid-us-supreme-court-curb-glyphosate-cases-2025-04-04/
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-11
Pay. Date : 2013-07-05
DMF Number : 1985
Submission : 1972-08-16
Status : Active
Type : II
Certificate Number : R1-CEP 1996-079 - Rev 07
Issue Date : 2017-03-03
Type : Chemical
Substance Number : 140
Status : Valid
Registration Number : 218MF10829
Registrant's Address : Kaiser-Wilhelm-Allee 1,51373 Leverkusen, Germany
Initial Date of Registration : 2006-10-20
Latest Date of Registration :
NDC Package Code : 12866-1016
Start Marketing Date : 2017-05-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2046
Submission : 1973-02-08
Status : Inactive
Type : II
Certificate Number : CEP 2000-110 - Rev 05
Issue Date : 2023-09-12
Type : Chemical
Substance Number : 234
Status : Valid
Registration Number : 219MF10281
Registrant's Address : Kaiser-Wilhelm-Allee 1,51373 Leverkusen, Germany
Initial Date of Registration : 2007-09-10
Latest Date of Registration :
NDC Package Code : 12866-1013
Start Marketing Date : 2017-05-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3379
Submission : 1978-11-02
Status : Active
Type : II
Registration Number : 222MF10134
Registrant's Address : Kaiser-Wilhelm-Allee 1,51373 Leverkusen, Germany
Initial Date of Registration : 2010-04-13
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12138
Submission : 1996-09-09
Status : Active
Type : II
Certificate Number : R1-CEP 2009-070 - Rev 02
Issue Date : 2022-07-27
Type : Chemical
Substance Number : 2404
Status : Valid
Registrant Name : Bayer Korea Ltd.
Registration Date : 2006-03-02
Registration Number : 309-2-ND
Manufacturer Name : Bayer AG@[Undifferentiated Process Manufacturer] Bayer AG
Manufacturer Address : Ernst-Schering-Straße 14 59192 Bergkamen, Germany@Max-Dohrn-Straße 8 10589 Berlin, Germany
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13061
Submission : 1998-07-07
Status : Active
Type : II
Certificate Number : CEP 2017-275 - Rev 02
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 2735
Status : Valid
Registrant Name : Bayer Korea Ltd.
Registration Date : 2004-11-05
Registration Number : 309-1-ND
Manufacturer Name : Bayer AG@Dynamit Nobel GmbH Explosivstoff- und Systemtechnik
Manufacturer Address : Ernst-Schering-Straße 14 59192 Bergkamen, Germany@Kalkstraße 218 51377 Leverkusen Germany
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-28
Pay. Date : 2013-01-08
DMF Number : 4178
Submission : 1981-05-21
Status : Active
Type : II
Certificate Number : R1-CEP 2000-101 - Rev 03
Issue Date : 2017-03-03
Type : Chemical
Substance Number : 926
Status : Valid
NDC Package Code : 12866-1010
Start Marketing Date : 2017-05-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-05
Pay. Date : 2013-01-28
DMF Number : 2726
Submission : 1976-08-05
Status : Active
Type : II
Certificate Number : R1-CEP 2013-050 - Rev 00
Issue Date : 2018-07-23
Type : Chemical
Substance Number : 234
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-04
Pay. Date : 2013-09-30
DMF Number : 2033
Submission : 1972-12-22
Status : Active
Type : II
Certificate Number : R1-CEP 2000-111 - Rev 04
Issue Date : 2017-06-22
Type : Chemical
Substance Number : 850
Status : Valid
NDC Package Code : 12866-1014
Start Marketing Date : 2017-05-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21580
Submission : 2008-07-23
Status : Active
Type : II
Certificate Number : R0-CEP 2021-090 - Rev 00
Issue Date : 2023-02-22
Type : Chemical
Substance Number : 2932
Status : Valid
NDC Package Code : 12527-0580
Start Marketing Date : 2014-05-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Bayer Korea Ltd.
Registration Date : 2008-06-27
Registration Number : Su2420-3-ND
Manufacturer Name : [Other than undifferentiated process (manufacturing of Rivaroxaban)] Bayer AG@[Undifferentiated manufacturing plant ①] Bayer AG@[Undifferentiated manufacturing plant ②] Bayer HealthCare Manufacturing Srl
Manufacturer Address : [Other than micronization process (manufacturing of rivaroxaban)] Werksteil Elberfeld Friedrich-Ebert-Straße 217-333 42117 Wuppertal Germany@[Micronization factory ①] 51368 leverkusen@[Micronization factory ②] Via delle Groane 126 20024 Garbagnate Milanese, Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-30
Pay. Date : 2013-01-10
DMF Number : 15077
Submission : 2000-10-02
Status : Active
Type : II
Certificate Number : R1-CEP 2000-109 - Rev 04
Issue Date : 2020-05-28
Type : Chemical
Substance Number : 1373
Status : Valid
Excipients
Inspections and registrations
ABOUT THIS PAGE
Bayer Pharma AG is a supplier offers 166 products (APIs, Excipients or Intermediates).
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