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16-17 September, 2024
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Webinars & Exhibitions
CPhI Worldwide, MilanCPhI Worldwide, Milan
Industry Trade Show
Not Confirmed
08-10 October, 2024
26th North American IS...26th North American ISSX
Industry Trade Show
Not Confirmed
15-18 September, 2024
Industry Trade Show
Not Confirmed
16-17 September, 2024
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/we-re-unlocking-life-changing-potential-in-complex-molecules-without-sacrificing-time-to-market
VLOG #PharmaReel
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10 Jan 2023
// INTELLINEWS
https://intellinews.com/china-s-porton-to-set-up-biotech-park-in-slovenia-s-menges-266425/?source=slovenia
16 Feb 2018
// PATENT LITIGATION
https://www.pharmacompass.com/pdf/news/imbruvica-ibrutinib-pharmacyclics-v-zydus-worldwide-dmcc-1520247536.pdf
30 Jan 2018
// PATENT LITIGATION
https://www.pharmacompass.com/pdf/news/trintellix-vortioxetineh-lundbeck-v-sandoz-1517811354.pdf
27 Jan 2016
// DCAT CONNECT
http://connect.dcat.org/blogs/pharma-news/2016/01/26/sandozs-lek-invests-in-final-dosage-form-biosimilar-capabilities#.Vqhfipp97IU
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13704
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 2005-121 - Rev 01
Issue Date : 2016-02-03
Type : Chemical
Substance Number : 331
Status : Valid
Registration Number : 220MF10041
Registrant's Address : Verovskova ulica 57, 1526 Ljubljana, Slovenia
Initial Date of Registration : 2008-02-05
Latest Date of Registration :
NDC Package Code : 48866-8256
Start Marketing Date : 2013-07-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT FOR ...
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20765
Submission : 2007-08-09
Status : Active
Type : II
Certificate Number : R0-CEP 2016-321 - Rev 01
Issue Date : 2019-04-15
Type : Chemical
Substance Number : 2631
Status : Withdrawn by Holder
Registration Number : 228MF10155
Registrant's Address : Verovskova ulica 57, 1526 Ljubljana, Slovenia
Initial Date of Registration : 2016-08-08
Latest Date of Registration :
Registrant Name : Sandoz Korea Co., Ltd.
Registration Date : 2021-04-06
Registration Number : 20210406-209-J-687
Manufacturer Name : Lek Pharmaceuticals d.d.
Manufacturer Address : Kolodvorska cesta 27,1234 Menges, Slovenia
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13223
Submission : 1998-04-30
Status : Inactive
Type : II
Certificate Number : R1-CEP 2004-179 - Rev 03
Issue Date : 2019-12-18
Type : Chemical
Substance Number : 1058
Status : Valid
Registration Number : 217MF10740
Registrant's Address : Verovskova 57, SI-1526 Ljubljana, Slovenia
Initial Date of Registration : 2005-10-07
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 : 16887
Submission : 2003-10-02
Status : Inactive
Type : II
Certificate Number : R1-CEP 2004-210 - Rev 00
Issue Date : 2011-07-01
Type : Chemical
Substance Number : 1491
Status : Withdrawn by Holder
Registration Number : 222MF10151
Registrant's Address : Verovskova ulica 57, 1000 Ljubljana, Slovenia
Initial Date of Registration : 2010-05-17
Latest Date of Registration :
Registrant Name : Novartis Korea Co., Ltd.
Registration Date : 2010-11-30
Registration Number : 20101130-130-H-45-06
Manufacturer Name : Lek Pharmaceuticals d.d.
Manufacturer Address : Kolodvorska cesta 27,1234 Menges, Slovenia
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18082
Submission : 2005-02-01
Status : Active
Type : II
Registration Number : 222MF10232
Registrant's Address : Verovskova ulica 57, 1000 Ljubljana, Slovenia
Initial Date of Registration : 2010-09-24
Latest Date of Registration :
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2011-11-11
Registration Number : 20101011-132-H-1-02(1)
Manufacturer Name : Lek Pharmaceuticals d.d.
Manufacturer Address : Kolodvorska cesta 27, 1234 Menges, Slovenia
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6827
Submission : 1987-02-13
Status : Active
Type : II
Registration Number : 221MF10054
Registrant's Address : Verovskova 57, SI-1526 Ljubljana, Slovenia
Initial Date of Registration : 2009-03-16
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 : 15211
Submission : 2000-12-26
Status : Active
Type : II
Certificate Number : R1-CEP 2007-258 - Rev 02
Issue Date : 2021-03-05
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 48866-9981
Start Marketing Date : 2022-11-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT FOR ...
Registrant Name : Leesung International Co., Ltd.
Registration Date : 2022-04-25
Registration Number : 20220425-113-F-96-26
Manufacturer Name : Lek farmacevtska družba dd, Poslovna enota Proizvodnja Lendava
Manufacturer Address : Trimlini 2D, Lendava, 9220, Slovenia
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-24
Pay. Date : 2018-05-17
DMF Number : 32777
Submission : 2018-05-17
Status : Active
Type : II
Certificate Number : R1-CEP 2007-259 - Rev 02
Issue Date : 2021-03-05
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 48866-9981
Start Marketing Date : 2022-11-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT FOR ...
Registrant Name : Leesung International Co., Ltd.
Registration Date : 2022-04-25
Registration Number : 20220425-113-F-96-26
Manufacturer Name : Lek farmacevtska družba dd, Poslovna enota Proizvodnja Lendava
Manufacturer Address : Trimlini 2D, Lendava, 9220, Slovenia
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-03-07
Pay. Date : 2023-02-02
DMF Number : 36941
Submission : 2023-01-17
Status : Active
Type : II
Certificate Number : R1-CEP 2007-260 - Rev 02
Issue Date : 2021-03-08
Type : Chemical
Substance Number : 1653
Status : Valid
NDC Package Code : 48866-9981
Start Marketing Date : 2022-11-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT FOR ...
Registrant Name : Leesung International Co., Ltd.
Registration Date : 2022-04-25
Registration Number : 20220425-113-F-96-26
Manufacturer Name : Lek farmacevtska družba dd, Poslovna enota Proizvodnja Lendava
Manufacturer Address : Trimlini 2D, Lendava, 9220, Slovenia
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-12-07
Pay. Date : 2022-11-23
DMF Number : 37008
Submission : 2023-09-27
Status : Active
Type : II
Certificate Number : R1-CEP 2003-262 - Rev 03
Issue Date : 2020-06-17
Type : Chemical
Substance Number : 1140
Status : Valid
NDC Package Code : 48866-9981
Start Marketing Date : 2022-11-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT FOR ...
Registrant Name : Leesung International Co., Ltd.
Registration Date : 2022-04-25
Registration Number : 20220425-113-F-96-26
Manufacturer Name : Lek farmacevtska družba dd, Poslovna enota Proizvodnja Lendava
Manufacturer Address : Trimlini 2D, Lendava, 9220, Slovenia
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16887
Submission : 2003-10-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22964
Submission : 2009-07-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-16
Pay. Date : 2017-09-11
DMF Number : 31809
Submission : 2017-09-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18082
Submission : 2005-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8292
Submission : 1989-11-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6827
Submission : 1987-02-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4289
Submission : 1981-09-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20053
Submission : 2006-12-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23222
Submission : 2009-10-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7863
Submission : 1988-12-13
Status : Inactive
Type : II
RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ACYCLOVIR
Dosage Strength : 400MG
Approval Date : 1997-04-22
Application Number : 74658
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ACYCLOVIR
Dosage Strength : 800MG
Approval Date : 1997-04-22
Application Number : 74658
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : CAPSULE; ORAL
Proprietary Name : ACYCLOVIR
Dosage Strength : 200MG
Approval Date : 1997-04-22
Application Number : 74750
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Dosage Form : CAPSULE; ORAL
Proprietary Name : BROMOCRIPTINE MESYLATE
Dosage Strength : EQ 5MG BASE
Approval Date : 1998-12-10
Application Number : 75100
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Inspections and registrations
ABOUT THIS PAGE
Lek Pharmaceuticals is a supplier offers 48 products (APIs, Excipients or Intermediates).
Find a price of Gentamicin Sulfate bulk with DMF, CEP, JDMF offered by Lek Pharmaceuticals
Find a price of Rosuvastatin Calcium bulk with DMF, JDMF offered by Lek Pharmaceuticals
Find a price of Vancomycin Hydrochloride bulk with CEP, JDMF offered by Lek Pharmaceuticals
Find a price of Amlodipine Besylate bulk with JDMF offered by Lek Pharmaceuticals
Find a price of Atorvastatin bulk with DMF, JDMF offered by Lek Pharmaceuticals
Find a price of Bromocriptine Mesylate bulk with DMF, JDMF offered by Lek Pharmaceuticals
Find a price of Clavulanic Acid bulk with DMF, CEP offered by Lek Pharmaceuticals
Find a price of Tacrolimus bulk with DMF, CEP offered by Lek Pharmaceuticals
Find a price of Candesartan Cilexetil bulk with JDMF offered by Lek Pharmaceuticals
Find a price of Lithium Carbonate bulk with JDMF offered by Lek Pharmaceuticals
Find a price of Mycophenolate Mofetil bulk with DMF offered by Lek Pharmaceuticals
Find a price of Mycophenolate Mofetil bulk with CEP offered by Lek Pharmaceuticals
Find a price of Amlodipine Besylate bulk with DMF offered by Lek Pharmaceuticals
Find a price of Apremilast bulk with DMF offered by Lek Pharmaceuticals
Find a price of Clavulanic Acid bulk with CEP offered by Lek Pharmaceuticals
Find a price of Dolutegravir Sodium bulk with DMF offered by Lek Pharmaceuticals
Find a price of Entecavir bulk with DMF offered by Lek Pharmaceuticals
Find a price of Ferric Carboxymaltose bulk with DMF offered by Lek Pharmaceuticals
Find a price of Ferumoxytol bulk with DMF offered by Lek Pharmaceuticals
Find a price of Lisinopril bulk offered by Lek Pharmaceuticals
Find a price of Lithium Carbonate bulk with DMF offered by Lek Pharmaceuticals
Find a price of Lovastatin bulk offered by Lek Pharmaceuticals
Find a price of Omeprazole bulk offered by Lek Pharmaceuticals
Find a price of Pravastatin bulk offered by Lek Pharmaceuticals
Find a price of Rosuvastatin Calcium bulk with DMF offered by Lek Pharmaceuticals
Find a price of Silver Sulfadiazine bulk with DMF offered by Lek Pharmaceuticals
Find a price of Simvastatin bulk offered by Lek Pharmaceuticals
Find a price of Sirolimus bulk with DMF offered by Lek Pharmaceuticals
Find a price of Sugammadex Sodium bulk with DMF offered by Lek Pharmaceuticals
Find a price of Tacrolimus bulk with DMF offered by Lek Pharmaceuticals
Find a price of Tamsulosin bulk with DMF offered by Lek Pharmaceuticals
Find a price of Ticagrelor bulk with DMF offered by Lek Pharmaceuticals
Find a price of Vancomycin Hydrochloride bulk with DMF offered by Lek Pharmaceuticals
Find a price of Vortioxetine Hydrobromide bulk with DMF offered by Lek Pharmaceuticals
Find a price of Auranofin bulk offered by Lek Pharmaceuticals
Find a price of Calcium Gluceptate bulk offered by Lek Pharmaceuticals
Find a price of Caspofungin bulk offered by Lek Pharmaceuticals
Find a price of Cimetidine bulk offered by Lek Pharmaceuticals
Find a price of Dihydroergotamine Mesylate bulk offered by Lek Pharmaceuticals
Find a price of Enalapril Maleate bulk offered by Lek Pharmaceuticals
Find a price of Fesoterodine bulk offered by Lek Pharmaceuticals
Find a price of Losartan Potassium bulk offered by Lek Pharmaceuticals
Find a price of Nifedipine bulk offered by Lek Pharmaceuticals
Find a price of Nitrofurantoin bulk offered by Lek Pharmaceuticals
Find a price of Olanzapine bulk offered by Lek Pharmaceuticals
Find a price of Propranolol Hydrochloride bulk offered by Lek Pharmaceuticals
Find a price of Rosuvastatin Calcium bulk offered by Lek Pharmaceuticals
Find a price of Tolterodine Tartrate bulk offered by Lek Pharmaceuticals
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