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// BIOSPECTRUM
https://www.biospectrumasia.com/news/25/25537/hikma-and-m42-sign-strategic-mou-to-advance-healthcare-innovation-in-uae.html
21 Jan 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216842
15 Jan 2025
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https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-15-2025-7287.pdf
14 Jan 2025
// CONTRACTPHARMA
https://www.contractpharma.com/breaking-news/hikma-partners-with-emergent-for-the-sale-of-kloxxado-in-the-u-s-canada/
08 Jan 2025
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-8-2025-53657.pdf
24 Dec 2024
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-hikmas-generic-version-novos-diabetes-drug-victoza-2024-12-23/
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-12-21
Pay. Date : 2022-12-19
DMF Number : 22181
Submission : 2008-11-13
Status : Active
Type : II
Certificate Number : R0-CEP 2017-185 - Rev 00
Issue Date : 2018-08-17
Type : Chemical
Substance Number : 2016
Status : Expired
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18126
Submission : 2005-02-28
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19809
Submission : 2006-09-28
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18727
Submission : 2005-08-31
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25298
Submission : 2011-09-11
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16089
Submission : 2002-08-06
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-04
Pay. Date : 2013-07-24
DMF Number : 25544
Submission : 2011-11-24
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23280
Submission : 2009-11-16
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20344
Submission : 2007-03-06
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16000
Submission : 2002-06-10
Status : Active
Type : II
NDC Package Code : 59115-823
Start Marketing Date : 2018-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Details:
Under the terms of the agreement, Emergent will be responsible for the distribution of Kloxxado (Naloxone HCl). It is being indicated for the treatment of known or suspected opioid overdose.
Lead Product(s): Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Kloxxado
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Emergent BioSolutions
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 14, 2025
Lead Product(s) : Naloxone Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Emergent BioSolutions
Deal Size : Undisclosed
Deal Type : Agreement
Emergent BioSolutions Gains Exclusive Rights to KLOXXADO® Nasal Spray
Details : Under the terms of the agreement, Emergent will be responsible for the distribution of Kloxxado (Naloxone HCl). It is being indicated for the treatment of known or suspected opioid overdose.
Product Name : Kloxxado
Product Type : Controlled Substance
Upfront Cash : Undisclosed
January 14, 2025
Details:
Victoza-Generic (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is indicated for the treatment of patients with type 2 diabetes mellitus.
Lead Product(s): Liraglutide
Therapeutic Area: Endocrinology Brand Name: Victoza-Generic
Study Phase: ApprovedProduct Type: Peptide
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 26, 2024
Lead Product(s) : Liraglutide
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
US FDA Approves Hikma's Generic Version of Novo's Diabetes Drug Victoza
Details : Victoza-Generic (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is indicated for the treatment of patients with type 2 diabetes mellitus.
Product Name : Victoza-Generic
Product Type : Peptide
Upfront Cash : Not Applicable
December 26, 2024
Details:
Furosemide injection is indicated in adults & pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.
Lead Product(s): Furosemide
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Furosemide Injection-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 09, 2024
Lead Product(s) : Furosemide
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Hikma launches Furosemide Injection, USP, in the US
Details : Furosemide injection is indicated in adults & pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.
Product Name : Furosemide Injection-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 09, 2024
Details:
Through the agreement, Collegium will exclusively manufacture and supply Hikma with all authorized generic products for sale, including Nucynta-Generic (tapentadol HCl).
Lead Product(s): Tapentadol
Therapeutic Area: Neurology Brand Name: Nucynta-Generic
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Collegium Pharmaceutical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement April 29, 2024
Lead Product(s) : Tapentadol
Therapeutic Area : Neurology
Highest Development Status : Approved
Recipient : Collegium Pharmaceutical
Deal Size : Undisclosed
Deal Type : Agreement
Collegium Announces Authorized Generic Agreement with Hikma for Nucynta® and Nucynta® ER
Details : Through the agreement, Collegium will exclusively manufacture and supply Hikma with all authorized generic products for sale, including Nucynta-Generic (tapentadol HCl).
Product Name : Nucynta-Generic
Product Type : Small molecule
Upfront Cash : Undisclosed
April 29, 2024
Details:
Combogesic IV (acetaminophen & ibuprofen) is an opioid-free pain relief medicine approved for adults to relieve mild to moderate pain and manage moderate to severe pain as an adjunct to opioids.
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Brand Name: Combogesic
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Hyloris Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2024
Lead Product(s) : Paracetamol,Ibuprofen
Therapeutic Area : Neurology
Highest Development Status : Approved
Recipient : Hyloris Pharmaceuticals
Deal Size : Not Applicable
Deal Type : Not Applicable
Hyloris Announces Launch of Maxigesic® IV in the U.S. and Approval in Canada
Details : Combogesic IV (acetaminophen & ibuprofen) is an opioid-free pain relief medicine approved for adults to relieve mild to moderate pain and manage moderate to severe pain as an adjunct to opioids.
Product Name : Combogesic
Product Type : Small molecule
Upfront Cash : Not Applicable
February 27, 2024
Details:
Combogesic IV (acetaminophen & ibuprofen) is an opioid-free pain relief medicine approved for adults to relieve mild to moderate pain and manage moderate to severe pain as an adjunct to opioids.
Lead Product(s): Paracetamol,Ibuprofen
Therapeutic Area: Neurology Brand Name: Combogesic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 05, 2024
Lead Product(s) : Paracetamol,Ibuprofen
Therapeutic Area : Neurology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Hikma Announces US Launch of COMBOGESIC® IV
Details : Combogesic IV (acetaminophen & ibuprofen) is an opioid-free pain relief medicine approved for adults to relieve mild to moderate pain and manage moderate to severe pain as an adjunct to opioids.
Product Name : Combogesic
Product Type : Small molecule
Upfront Cash : Not Applicable
February 05, 2024
Details:
Under the agreement, Hikma gains right for MAb-B43.13 (oregovomab), a murine monoclonal antibody, being tested in combination with carboplatin and paclitaxel for patients with advanced ovarian cancer, in the Middle East and North Africa (MENA) region.
Lead Product(s): Oregovomab,Paclitaxel,Carboplatin
Therapeutic Area: Oncology Brand Name: MAb-B43.13
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: CanariaBio
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 10, 2023
Lead Product(s) : Oregovomab,Paclitaxel,Carboplatin
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : CanariaBio
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : Under the agreement, Hikma gains right for MAb-B43.13 (oregovomab), a murine monoclonal antibody, being tested in combination with carboplatin and paclitaxel for patients with advanced ovarian cancer, in the Middle East and North Africa (MENA) region.
Product Name : MAb-B43.13
Product Type : Large molecule
Upfront Cash : Undisclosed
October 10, 2023
Details:
Under the terms of the agreement, Hikma will receive from Cosmo, the exclusive right to register and commercialize Winlevi (clascoterone) in African countries, which is indicated for acne vulgaris.
Lead Product(s): Clascoterone
Therapeutic Area: Dermatology Brand Name: Winlevi
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Cosmo Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: $0.7 million
Deal Type: Licensing Agreement October 02, 2023
Lead Product(s) : Clascoterone
Therapeutic Area : Dermatology
Highest Development Status : Approved
Recipient : Cosmo Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Cosmo and Hikma Sign License for Winlevi® in 17 Middle East and North Africa Countries
Details : Under the terms of the agreement, Hikma will receive from Cosmo, the exclusive right to register and commercialize Winlevi (clascoterone) in African countries, which is indicated for acne vulgaris.
Product Name : Winlevi
Product Type : Small molecule
Upfront Cash : $0.7 million
October 02, 2023
Details:
Under the terms of the agreement, Hikma will have priority rights for the commercialisation and manufacture of SK Biopharmaceuticals’ current and future pipeline of innovative products for 17 countries in the MENA region.
Lead Product(s): Cenobamate
Therapeutic Area: Neurology Brand Name: Xcopri
Study Phase: ApprovedProduct Type: Small molecule
Recipient: SK Biopharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 21, 2023
Lead Product(s) : Cenobamate
Therapeutic Area : Neurology
Highest Development Status : Approved
Recipient : SK Biopharmaceuticals
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Korea's SK Biopharma Enters MENA Through Strategic Partnership with Hikma
Details : Under the terms of the agreement, Hikma will have priority rights for the commercialisation and manufacture of SK Biopharmaceuticals’ current and future pipeline of innovative products for 17 countries in the MENA region.
Product Name : Xcopri
Product Type : Small molecule
Upfront Cash : Undisclosed
August 21, 2023
Details:
Under the terms of the agreement, Hikma has an exclusive license to commercialize products in Rakuten Medical's pipeline using its photoimmunotherapy technology platform, Alluminox™, in all its MENA markets.
Lead Product(s): Cetuximab Sarotalocan Sodium
Therapeutic Area: Oncology Brand Name: ASP-1929
Study Phase: Phase IIIProduct Type: Large molecule
Recipient: Rakuten Medical
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement August 10, 2023
Lead Product(s) : Cetuximab Sarotalocan Sodium
Therapeutic Area : Oncology
Highest Development Status : Phase III
Recipient : Rakuten Medical
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Rakuten Medical and Hikma Sign Exclusive Licensing Agreement for Alluminox™ Platform Cancer Trea...
Details : Under the terms of the agreement, Hikma has an exclusive license to commercialize products in Rakuten Medical's pipeline using its photoimmunotherapy technology platform, Alluminox™, in all its MENA markets.
Product Name : ASP-1929
Product Type : Large molecule
Upfront Cash : Undisclosed
August 10, 2023
Inspections and registrations
API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Hikma Farmaceutica
Business Address : Estrada Rio Da Mo 8/8a/8b TE...
FEI Number : 3002807173
Country : United Kingdom
Paid in : 2019
API Manufacturer : API MANUFACTURE
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Hikma Pharmaceuticals LLC
Business Address : 8th Circle Industrial Area A...
FEI Number : 3002806351
Country : United Kingdom
Paid in : 2019
API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Hikma Pharmaceuticals USA Inc.
Business Address : 2 Esterbrook Lane Cherry Hil...
FEI Number : 2220525
Country : U.S.A
Paid in : 2019
API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : HIkma Pharmaceuticals USA Inc.
Business Address : 246 Industrial Way West Eato...
FEI Number : 2250102
Country : U.S.A
Paid in : 2019
API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Jazeera Pharmaceutical Industr...
Business Address : Riyadh Gallery Building King...
FEI Number : 3004138409
Country : Saudi Arabia
Paid in : 2019
API Manufacturer :
FDF Manufacturer : FDF MANUFACTURE
Facility Name : Thymoorgan Pharmazie GmbH
Business Address : Schiffgraben 33 Goslar 38690...
FEI Number : 3002320821
Country : Germany
Paid in : 2019
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