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INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/due-to-its-20-year-mastery-in-micronization-inke-has-emerged-a-cornerstone-in-treating-global-respiratory-diseases
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04 Nov 2024
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/biontech-lowers-full-year-revenue-outlook-covid-19-seasonality-inventory-write-2024-11-04/
04 Nov 2024
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https://www.prnewswire.com/news-releases/international-and-regional-experts-address-the-role-of-vaccines-in-disease-management-during-pfizer-mera-vaccines-summit-2024-302295409.html
04 Nov 2024
// BUSINESSWIRE
29 Oct 2024
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29 Oct 2024
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https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-raises-profit-forecast-after-beating-third-quarter-estimates-2024-10-29/
29 Oct 2024
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/pfizers-paxlovid-sales-lift-revenue-bump-profit-outlook-15b-amid-criticism-activist-investor
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11848
Submission : 1996-02-08
Status : Active
Type : II
Certificate Number : R0-CEP 2001-070 - Rev 00
Issue Date : 2002-03-04
Type : TSE
Substance Number :
Status : Expired
Registration Number : 222MF10213
Registrant's Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA
Initial Date of Registration : 2010-08-05
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 : 6065
Submission : 1985-10-16
Status : Active
Type : II
Registration Number : 218MF10929
Registrant's Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA
Initial Date of Registration : 2006-11-21
Latest Date of Registration :
NDC Package Code : 0009-5164
Start Marketing Date : 2014-07-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
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 : 4796
Submission : 1983-01-06
Status : Active
Type : II
Certificate Number : CEP 2006-058 - Rev 03
Issue Date : 2024-03-07
Type : Chemical
Substance Number : 561
Status : Valid
NDC Package Code : 0009-0038
Start Marketing Date : 2014-07-03
End Marketing Date : 2024-12-31
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 : 1432
Submission : 1969-09-18
Status : Inactive
Type : II
Certificate Number : R0-CEP 2001-018 - Rev 00
Issue Date : 2001-10-24
Type : TSE
Substance Number :
Status : Withdrawn by Holder
Registration Number : 227MF10238
Registrant's Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA
Initial Date of Registration : 2015-09-29
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 : 22417
Submission : 2009-01-29
Status : Inactive
Type : II
Registration Number : 301MF10022
Registrant's Address : Little Island, Co. Cork, T45 F627, Ireland
Initial Date of Registration : 2019-06-25
Latest Date of Registration :
NDC Package Code : 61947-0002
Start Marketing Date : 2011-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : HKINNOEN Co., Ltd.
Registration Date : 2019-09-24
Registration Number : 20110110-132-H-57-04(1)
Manufacturer Name : Upjohn Manufacturing Ireland Unlimited Company
Manufacturer Address : Little Island, Co, Cork, T45 F627, Ireland
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2001-046 - Rev 00
Issue Date : 2002-01-28
Type : TSE
Substance Number :
Status : Expired
Registration Number : 221MF10091
Registrant's Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA
Initial Date of Registration : 2009-05-13
Latest Date of Registration :
NDC Package Code : 0009-5010
Start Marketing Date : 2016-05-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Novartis Korea Ltd.
Registration Date : 2022-11-02
Registration Number : 20220422-209-J-1258(1)
Manufacturer Name : Pharmacia & Upjohn Company LLC
Manufacturer Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5047
Submission : 1983-07-25
Status : Active
Type : II
Certificate Number : R0-CEP 2000-394 - Rev 00
Issue Date : 2001-11-05
Type : TSE
Substance Number :
Status : Withdrawn by Holder
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6258
Submission : 1986-03-27
Status : Active
Type : II
Certificate Number : R0-CEP 2000-408 - Rev 00
Issue Date : 2001-11-16
Type : TSE
Substance Number :
Status : Withdrawn by Holder
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4813
Submission : 1983-01-06
Status : Active
Type : II
Certificate Number : R0-CEP 2000-363 - Rev 00
Issue Date : 2001-10-24
Type : TSE
Substance Number : 933
Status : Withdrawn by Holder
NDC Package Code : 0009-0026
Start Marketing Date : 2014-07-03
End Marketing Date : 2024-12-31
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 : 15079
Submission : 2000-10-06
Status : Inactive
Type : II
Registration Number : 221MF10272
Registrant's Address : 4876 Sterling Drive Boulder, CO 80301, USA
Initial Date of Registration : 2009-12-09
Latest Date of Registration :
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-68-A-132-02
Manufacturer Name : Corden Pharma Boulder, Inc.
Manufacturer Address : 4876 Sterling Drive, Boulder, Colorado (CO) 80301, USA
Regulatory Info :
Registration Country : Italy
Dosage Form : Idarubicin 10Mg 1 Combined Ora...
Dosage Strength : 1 cps 10 mg vial
Packaging :
Brand Name : Zaved
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Idarubicin 25Mg 1 Combined Ora...
Dosage Strength : 1 cps 25 mg vial
Packaging :
Brand Name : Zaved
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Idarubicin 5Mg 1 Combined Oral...
Dosage Strength : 1 cps 5 mg bottle
Packaging :
Brand Name : Zaved
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Idarubicin 10Mg 1 Unit Parente...
Dosage Strength : 1 bottle groun EV 10 mg
Packaging :
Brand Name : Zavedos
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Idarubicin 10Mg 10Ml 1 Units P...
Dosage Strength : 1 ampoule EV 10 mg 10 ml
Packaging :
Brand Name : Zavedos
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Idarubicin 5Mg 5Ml 1 Units Par...
Dosage Strength : 1 ampoule EV 5 mg + 1 ampou...
Packaging :
Brand Name : Zavedos
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Film-Coated Tablets
Dosage Strength : 100mg
Packaging :
Brand Name : Cibinqo
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Film-Coated Tablets
Dosage Strength : 50mg
Packaging :
Brand Name : Cibinqo
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Acetyl-Lysyl-Prolyl-Seryl-Seryl-Prolyl-Prolyl-Glutamyl-Glutamic Acid Amide
Dosage Form : Urokinase 100.000Iu 2Ml 1 Unit...
Dosage Strength : 1 bottle 100,000 IU + 1 amp...
Packaging :
Brand Name : Urokinasi
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Sweden
Dosage Form : TABLET
Dosage Strength : 160 MG
Packaging :
Brand Name : Trombyl
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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Inspections and registrations
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Array BioPharma is a supplier offers 213 products (APIs, Excipients or Intermediates).
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