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12 Dec 2025
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/gsk-gains-fda-expansion-antibiotic-blujepa-treatment-gonorrhea

12 Dec 2025
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/gsk-long-acting-asthma-med-and-more-secure-chmp-backing

10 Dec 2025
// PHARMIWEB
https://www.pharmiweb.com/press-release/2025-12-10/oxford-biotherapeutics-enters-into-a-strategic-collaboration-with-gsk-to-discover-novel-targets-for-antibody-based-therapeutics-for-the-treatment-of-c

10 Dec 2025
// FIERCE BIOTECH
https://www.fiercebiotech.com/biotech/sanofi-gsk-ink-preclinical-pacts-quest-new-autoimmune-and-cancer-antibodies

09 Dec 2025
// BIOSPACE
https://www.biospace.com/business/gsk-cuts-five-year-old-cancer-collaboration-with-ideaya

05 Dec 2025
// ECONOMICTIMES
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/gsk-india-plans-big-reinvention-md-bhushan-akshikar-reveals/articleshow/125778731.cms
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24411
Submission : 2011-03-01
Status : Active
Type : II
Certificate Number : R1-CEP 2005-208 - Rev 00
Issue Date : 2013-07-02
Type : Chemical
Substance Number : 992
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31534
Submission : 2017-04-11
Status : Active
Type : II
Certificate Number : CEP 2018-229 - Rev 03
Issue Date : 2025-04-25
Type : Chemical
Substance Number : 1750
Status : Valid
NDC Package Code : 63379-001
Start Marketing Date : 2014-04-18
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13201
Submission : 1998-04-30
Status : Inactive
Type : II
Certificate Number : CEP 2000-010 - Rev 06
Issue Date : 2024-11-25
Type : Chemical
Substance Number : 260
Status : Valid
Registrant Name : Ilsung IS Co., Ltd.
Registration Date : 2011-10-28
Registration Number : 20050831-30-A-64-05(1)
Manufacturer Name : Beecham Pharmaceuticals (Pte) Ltd
Manufacturer Address : 38 Quality Road Jurong Industrial Estate, Singapore 618809

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13207
Submission : 1998-04-30
Status : Inactive
Type : II
Certificate Number : CEP 2015-064 - Rev 01
Issue Date : 2024-10-24
Type : Chemical
Substance Number : 260
Status : Valid
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2005-08-31
Registration Number : 20050831-30-A-64-05
Manufacturer Name : Beecham Pharmaceuticals (Pte) Ltd
Manufacturer Address : 38 Quality Road Jurong Industrial Estate, Singapore 618809

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4578
Submission : 1982-06-09
Status : Inactive
Type : II
Certificate Number : CEP 2002-219 - Rev 09
Issue Date : 2024-10-25
Type : Chemical
Substance Number : 811
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13650
Submission : 2000-08-10
Status : Inactive
Type : II
Certificate Number : R1-CEP 2004-306 - Rev 01
Issue Date : 2013-07-02
Type : Chemical
Substance Number : 1405
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4349
Submission : 1981-12-02
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-113 - Rev 04
Issue Date : 2014-02-26
Type : Chemical
Substance Number : 1140
Status : Valid
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2020-03-10
Registration Number : 20200310-113-F-91-24
Manufacturer Name : SmithKline Beecham Pharmaceuticals
Manufacturer Address : Shewalton Road, Irvine, KA11 5AP United Kingdom

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5701
Submission : 1985-02-13
Status : Inactive
Type : II
Certificate Number : CEP 1999-111 - Rev 04
Issue Date : 2024-11-13
Type : Chemical
Substance Number : 1140
Status : Valid
Registrant Name : Ilsung IS Co., Ltd.
Registration Date : 2011-12-09
Registration Number : 20090227-113-F-18-13(1)
Manufacturer Name : SmithKline Beecham Pharmaceuticals
Manufacturer Address : Shewalton Road GB-KA11 5AP Irvine Ayrshire

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7048
Submission : 1987-07-09
Status : Inactive
Type : II
Certificate Number : CEP 2005-244 - Rev 02
Issue Date : 2025-11-14
Type : Chemical
Substance Number : 1653
Status : Valid
Registrant Name : Ilsung IS Co., Ltd.
Registration Date : 2011-12-09
Registration Number : 20090227-113-F-19-12(1)
Manufacturer Name : SmithKline Beecham PLC
Manufacturer Address : Clarendon road Worthing West Sussex BN14 8QH

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25444
Submission : 2012-12-20
Status : Inactive
Type : II
Certificate Number : CEP 2011-034 - Rev 04
Issue Date : 2024-10-24
Type : Chemical
Substance Number : 2127
Status : Valid
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2012-03-23
Registration Number : 20120323-93-E-99-05
Manufacturer Name : Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations)
Manufacturer Address : Cobden Street, Montrose, Angus, DD10 8EA

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Regulatory Info : Allowed
Registration Country : Switzerland
Amoxicillin Anhydrous; Clavulanic Acid
Dosage Form : Film Coated Tablet
Brand Name : Augmentin ()
Dosage Strength : 500mg;125mg
Packaging :
Approval Date : 25/11/1983
Application Number : 45674
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Amoxicillin Anhydrous; Clavulanic Acid
Dosage Form : Film Coated Tablet
Brand Name : Augmentin ()
Dosage Strength : 875mg;125mg
Packaging :
Approval Date : 15/12/1995
Application Number : 53692
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Amoxicillin Anhydrous; Clavulanic Acid
Dosage Form : Powder For Oral Suspensi...
Brand Name : Augmentin Duo ()
Dosage Strength : 400mg;57mg
Packaging :
Approval Date : 25/06/1998
Application Number : 53974
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Atovaquone; Proguanil Hydrochloride
Dosage Form : Film Coated Tablet
Brand Name : Malarone
Dosage Strength :
Packaging :
Approval Date : 05/06/1997
Application Number : 54150
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Allowed
Registration Country : Switzerland
Atovaquone; Proguanil Hydrochloride
Dosage Form : Film Coated Tablet
Brand Name : Malarone Junior
Dosage Strength :
Packaging :
Approval Date : 05/06/1997
Application Number : 54150
Regulatory Info : Allowed
Registration Country : Switzerland

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Powder For Concentrate F...
Brand Name : Benlysta
Dosage Strength : 120mg
Packaging :
Approval Date : 13/07/2011
Application Number : 20100612000178
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Solution For Injection
Brand Name : Benlysta
Dosage Strength : 200mg
Packaging :
Approval Date : 10/11/2017
Application Number : 20160927000058
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Solution For Injection
Brand Name : Benlysta
Dosage Strength : 200mg
Packaging :
Approval Date : 10/11/2017
Application Number : 20160927000041
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Powder For Concentrate F...
Brand Name : Benlysta
Dosage Strength : 400mg
Packaging :
Approval Date : 13/07/2011
Application Number : 20100612000185
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Allowed
Registration Country : Switzerland
Dosage Form : Solution For Injection
Brand Name : Benlysta
Dosage Strength : 120mg
Packaging :
Approval Date : 14/06/2012
Application Number : 61532
Regulatory Info : Allowed
Registration Country : Switzerland

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RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ZIAGEN
Dosage Strength : EQ 300MG BASE **Federal ...
Approval Date : 1998-12-17
Application Number : 20977
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code : AA
Dosage Form : SOLUTION; ORAL
Proprietary Name : ZIAGEN
Dosage Strength : EQ 20MG BASE/ML
Approval Date : 1998-12-17
Application Number : 20978
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AA

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RLD : Yes
TE Code :
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
Dosage Form : TABLET; ORAL
Proprietary Name : TRIUMEQ
Dosage Strength : EQ 600MG BASE;EQ 50MG BA...
Approval Date : 2014-08-22
Application Number : 205551
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
Dosage Form : TABLET, FOR SUSPENSION; ORAL
Proprietary Name : TRIUMEQ PD
Dosage Strength : EQ 60MG BASE;EQ 5MG BASE...
Approval Date : 2022-03-30
Application Number : 215413
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : EPZICOM
Dosage Strength : EQ 600MG BASE;300MG **Fe...
Approval Date : 2004-08-02
Application Number : 21652
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
Dosage Form : TABLET; ORAL
Proprietary Name : TRIZIVIR
Dosage Strength : EQ 300MG BASE;150MG;300M...
Approval Date : 2000-11-14
Application Number : 21205
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :

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RLD : Yes
TE Code :
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Dosage Form : TABLET; ORAL
Proprietary Name : EXCEDRIN (MIGRAINE RELIE...
Dosage Strength : 250MG;250MG;65MG
Approval Date : 1998-01-14
Application Number : 20802
RX/OTC/DISCN : OTC
RLD : Yes
TE Code :

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RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : EMPRACET W/ CODEINE PHOS...
Dosage Strength : 300MG;30MG
Approval Date : 1982-01-01
Application Number : 83951
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : EMPRACET W/ CODEINE PHOS...
Dosage Strength : 300MG;60MG
Approval Date : 1982-01-01
Application Number : 83951
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ADVIL DUAL ACTION WITH A...
Dosage Strength : 250MG;125MG
Approval Date : 2020-02-28
Application Number : 211733
RX/OTC/DISCN : OTC
RLD : Yes
TE Code :

Excipients
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5770
Submission : 1985-04-08
Status : Inactive
Type : IV

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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5770
Submission : 1985-04-08
Status : Inactive
Type : IV

Excipients Web Link
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GlaxoSmithKline Manufacturing SpA is a supplier offers 142 products (APIs, Excipients or Intermediates).
Find a price of Cefuroxime Sodium bulk with DMF, CEP offered by GlaxoSmithKline Manufacturing SpA
Find a price of Fluticasone Propionate bulk with DMF, CEP offered by GlaxoSmithKline Manufacturing SpA
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