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02-03 March, 2026
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Events
Webinars & Exhibitions
Industry Trade Show
Not Confirmed
26-28 February, 2026
euroPLX 90 LisboneuroPLX 90 Lisbon
Industry Trade Show
Not Confirmed
02-03 March, 2026
BIO CEO & InvestorBIO CEO & Investor
Industry Trade Show
Not Confirmed
02-03 March, 2026
Digital content

11 Feb 2026
// EXPRESSPHARMA
https://www.expresspharma.in/onesource-specialty-pharma-secures-sfda-approval-for-generic-semaglutide-in-saudi-arabia/

10 Feb 2026
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205057

05 Feb 2026
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207069

20 Jan 2026
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/supreme-court-agrees-review-skinny-label-battle-hikma-amarin-over-generic-vascepa

09 Dec 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/hikma-launches-tyzavan-vancomycin-injection-usp-in-the-us-302635687.html

06 Nov 2025
// PHARMIWEB
https://www.pharmiweb.com/press-release/2025-11-06/hikma-confirms-2025-guidance-and-updates-medium-term-growth-outlook
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23036
Submission : 2009-08-09
Status : Active
Type : II
Certificate Number : CEP 2023-275 - Rev 00
Issue Date : 2024-12-13
Type : Chemical
Substance Number : 2743
Status : Valid

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
NDC Package Code : 59115-809
Start Marketing Date : 2011-09-21
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 : 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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18126
Submission : 2005-02-28
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13220
Submission : 1998-04-30
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16659
Submission : 2003-06-19
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5541
Submission : 1984-09-27
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30165
Submission : 2015-12-29
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19809
Submission : 2006-09-28
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29437
Submission : 2015-05-28
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18727
Submission : 2005-08-31
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25298
Submission : 2011-09-11
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16089
Submission : 2002-08-06
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ABIRATERONE ACETATE
Dosage Strength : 250MG
Approval Date : 2018-10-31
Application Number : 208339
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACARBOSE
Dosage Strength : 25MG
Approval Date : 2008-05-07
Application Number : 78470
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACARBOSE
Dosage Strength : 50MG
Approval Date : 2008-05-07
Application Number : 78470
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ACARBOSE
Dosage Strength : 100MG
Approval Date : 2008-05-07
Application Number : 78470
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AP1
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : ACETAMINOPHEN
Dosage Strength : 1GM/100ML (10MG/ML)
Approval Date : 2016-06-13
Application Number : 202605
RX/OTC/DISCN : RX
RLD : No
TE Code : AP1

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RLD : Yes
TE Code :
Dosage Form : SOLUTION; INTRAVENOUS
Proprietary Name : ACETAMINOPHEN
Dosage Strength : 1GM/100ML (10MG/ML)
Approval Date : 2022-06-03
Application Number : 206968
RX/OTC/DISCN : RX
RLD : Yes
TE Code :

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RLD : No
TE Code :
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : CAPSULE; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 500MG;50MG;40MG
Approval Date : 1998-10-28
Application Number : 40261
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : TABLET; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 500MG;50MG;40MG
Approval Date : 1999-08-18
Application Number : 40336
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : TABLET; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 325MG;50MG;40MG
Approval Date : 1995-06-12
Application Number : 89718
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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RLD : No
TE Code :
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Dosage Form : CAPSULE; ORAL
Proprietary Name : BUTALBITAL, ACETAMINOPHE...
Dosage Strength : 300MG;50MG;40MG
Approval Date : 2022-03-25
Application Number : 215135
RX/OTC/DISCN : DISCN
RLD : No
TE Code :

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Powder For Solution For Infusi...
Dosage Strength : 250MG
Packaging :
Brand Name : Aciclovir Hikma
Approval Date : 25-09-2018
Application Number : 81361
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Injectable Solution
Dosage Strength : 6MG
Packaging :
Brand Name : Adenosina Hikma
Approval Date : 11-11-2021
Application Number : 86371
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info :
Registration Country : Italy
Dosage Form : Amiodarone 150Mg 3Ml 10 Units ...
Dosage Strength : 10 VIALS EV 150 mg 3 ml
Packaging :
Brand Name : Amiodarone
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info : Prescription
Registration Country : Denmark
Dosage Form : Injectable Solution
Dosage Strength : 25mg/ml
Packaging :
Brand Name : Azacitidine \"Hikma\"
Approval Date : 17-09-2024
Application Number : 28107171624
Regulatory Info : Prescription
Registration Country : Denmark

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Powder For Injectable Suspensi...
Dosage Strength : 25MG
Packaging :
Brand Name : Azacitidine Hikma
Approval Date : 09-12-2022
Application Number : 87680
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Solution For Injection
Dosage Strength : 25mg/ml
Packaging :
Brand Name : Azacitidine Hikma
Approval Date : 24-09-2024
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Authorized
Registration Country : Spain
Bendamustine Hydrochloride Monohydrate
Dosage Form : Powder For Concentrate For Sol...
Dosage Strength : 2.5MG
Packaging :
Brand Name : Bendamustina Hikma
Approval Date : 30-12-2019
Application Number : 84770
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info :
Registration Country : Italy
Dosage Form : Bicalutamide 50Mg 28 Combined ...
Dosage Strength : 28 cpr riv 50 mg
Packaging :
Brand Name : Bicalutamide
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info :
Registration Country : Italy
Dosage Form : Bicalutamide 150Mg 28 Combined...
Dosage Strength : 28 cpr riv 150 mg
Packaging :
Brand Name : Bicalutamide
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Powder For Concentrate For Sol...
Dosage Strength : 250MG
Packaging :
Brand Name : Bivalirudine Hikma
Approval Date : 25-09-2025
Application Number : 90576
Regulatory Info : Authorized
Registration Country : Spain

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Hikma Pharmaceuticals is a supplier offers 31 products (APIs, Excipients or Intermediates).
Find a price of Zoledronic Acid bulk with DMF, CEP offered by Hikma Pharmaceuticals
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Find a price of Milrinone bulk with DMF offered by Hikma Pharmaceuticals
Find a price of Nicardipine Hydrochloride bulk with DMF offered by Hikma Pharmaceuticals
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Find a price of HIK-079 bulk with DMF offered by Hikma Pharmaceuticals
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Find a price of Cefadroxil bulk offered by Hikma Pharmaceuticals
Find a price of Cortisone bulk offered by Hikma Pharmaceuticals
Find a price of FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN AMMAN JORDON bulk offered by Hikma Pharmaceuticals
Find a price of MANUFACTURING SITE, FACILITIES, OPERATING PROCEDURES AND PERSONNEL IN AMMAN, JORDAN bulk offered by Hikma Pharmaceuticals
Find a price of Benztropine bulk offered by Hikma Pharmaceuticals
Find a price of Fluticasone Propionate bulk offered by Hikma Pharmaceuticals
Find a price of Ibrutinib bulk offered by Hikma Pharmaceuticals
Find a price of Ondansetron bulk offered by Hikma Pharmaceuticals
Find a price of Prifinium Bromide bulk offered by Hikma Pharmaceuticals
Find a price of Ruxolitinib Phosphate bulk offered by Hikma Pharmaceuticals
Find a price of Thiotepa bulk offered by Hikma Pharmaceuticals