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GDUFA
DMF Review : Complete
Rev. Date : 2013-05-09
Pay. Date : 2013-04-25
DMF Number : 21480
Submission : 2008-03-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-18
Pay. Date : 2014-11-19
DMF Number : 28781
Submission : 2014-11-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6887
Submission : 1987-03-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-20
Pay. Date : 2016-06-30
DMF Number : 30646
Submission : 2016-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-23
DMF Number : 15601
Submission : 2001-08-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-19
Pay. Date : 2017-12-05
DMF Number : 32247
Submission : 2017-12-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9573
Submission : 1992-03-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6711
Submission : 1986-12-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17143
Submission : 2004-02-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2012-12-06
DMF Number : 9701
Submission : 1992-05-27
Status : Active
Type : II
CEP/COS
Certificate Numbers : R1-CEP 2013-353 - Rev 00
Status : Valid
Issue Date : 2019-04-24
Type : Chemical
Substance Number : 2760
CEP/COS
Certificate Numbers : CEP 2018-123 - Rev 02
Status : Valid
Issue Date : 2024-02-19
Type : Chemical
Substance Number : 657
Certificate Numbers : R1-CEP 1993-009 - Rev 04
Status : Withdrawn by Holder
Issue Date : 2009-02-16
Type : Chemical
Substance Number : 658
Certificate Numbers : CEP 2017-128 - Rev 01
Status : Valid
Issue Date : 2025-05-05
Type : Chemical
Substance Number : 658
CEP/COS
Certificate Numbers : CEP 2018-081 - Rev 02
Status : Valid
Issue Date : 2024-02-19
Type : Chemical
Substance Number : 659
CEP/COS
Certificate Numbers : R1-CEP 2008-151 - Rev 00
Status : Valid
Issue Date : 2015-07-13
Type : Chemical
Substance Number : 1191
CEP/COS
Certificate Numbers : R1-CEP 2004-213 - Rev 01
Status : Valid
Issue Date : 2012-05-18
Type : Chemical
Substance Number : 1013
CEP/COS
Certificate Numbers : R1-CEP 2011-225 - Rev 00
Status : Valid
Issue Date : 2017-07-04
Type : Chemical
Substance Number : 2173
CEP/COS
Certificate Numbers : R1-CEP 2007-178 - Rev 00
Status : Valid
Issue Date : 2013-09-05
Type : Chemical
Substance Number : 2338
Certificate Numbers : R1-CEP 2010-336 - Rev 00
Status : Valid
Issue Date : 2017-05-30
Type : Chemical
Substance Number : 2296
JDMF
Registration Number : 301MF10021
Registrant's Address : 6-8, Fructo(´)s Gelabert 08970 Sant Joan Despi(´)(Barcelona) Spain
Initial Date of Registration : 2019-06-25
Latest Date of Registration : 2019-06-25
JDMF
Registration Number : 305MF10019
Registrant's Address : HF61, Hal Far Industrial Estate Hal Far, BBG3000. Malta
Initial Date of Registration : 2023-02-02
Latest Date of Registration : 2023-02-02
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2019-11-26
Registration Number : Su133-10-ND
Manufacturer Name : Medichem Manufacturing (Malta)...
Manufacturer Address : HF-61 Hal Far Industrial Estate, Birzebbugia BBG 3000, Malta
Registrant Name : Hansol Pharma Co., Ltd.
Registration Date : 2024-05-01
Registration Number : 20141201-200-I-451-04(1)
Manufacturer Name : MEDICHEM SA
Manufacturer Address : Pirineus street, 127, Poligon Industrial de Celra, 17460 Celra (Girona), Spain
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2014-12-01
Registration Number : 20141201-200-I-451-04
Manufacturer Name : MEDICHEM,SA
Manufacturer Address : Poligon Industrial de Celra 17460 Celra (GIRONA), Spain
Registrant Name : Hwanin Pharmaceutical Co., Ltd.
Registration Date : 2020-05-04
Registration Number : 20180903-209-J-157(2)
Manufacturer Name : Medichem SA
Manufacturer Address : Poligon Industrial de Celra 17460 CELRA (Girona), Spain
Registrant Name : Dongwha Pharmaceutical Co., Ltd.
Registration Date : 2018-10-23
Registration Number : 20180903-209-J-157(1)
Manufacturer Name : Medichem SA
Manufacturer Address : Poligon Industrial de Celra 17460
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2018-09-03
Registration Number : 20180903-209-J-157
Manufacturer Name : Medichem SA
Manufacturer Address : Poligon Industrial de Celra 17460 CELRA (Girona), Spain
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2007-12-28
Registration Number : 20071228-78-D-30-09
Manufacturer Name : Medichem SA
Manufacturer Address : Pollgono Industrial de Celra 17460 Celra. Girona.Spain
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2022-02-04
Registration Number : 20220204-209-J-1227
Manufacturer Name : MEDICHEM SA
Manufacturer Address : Pirineus street, 127, Poligon Industrial de Celra, 17460 Celra (Girona), Spain
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-11-28
Registration Number : 207-58-ND
Manufacturer Name : Medichem SA
Manufacturer Address : Polígono Industrial de Celrà 17460 Celrà (Girona) SPAIN
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-04-29
Registration Number : 20210429-209-J-964
Manufacturer Name : Medichem SA
Manufacturer Address : Poligon Industrial de Celra 17460 Celra (GIRONA), Spain
NDC Package Code : 53296-0068
Start Marketing Date : 2010-05-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 16436-0111
Start Marketing Date : 2014-02-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53296-0018
Start Marketing Date : 2010-03-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 16436-0113
Start Marketing Date : 2014-03-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53296-0104
Start Marketing Date : 2011-04-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53296-0050
Start Marketing Date : 2014-09-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53296-0031
Start Marketing Date : 2010-03-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53296-0010
Start Marketing Date : 2010-06-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53296-0009
Start Marketing Date : 2010-03-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53296-0011
Start Marketing Date : 2010-03-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceut...
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceut...
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceut...
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceut...
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceut...
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceut...
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceut...
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceut...
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceut...
About the Company : Medichem is an indepently-owned company based in Barcelona. Founded in 1972 and with more than 45 years, Medichem has been engaged in the process development and manufacture of Active Pharmaceut...
Regulatory Info :
Registration Country : Spain
2-Phenoxyethanol; Octenidine Hydrochloride
Dosage Form : Spray
Brand Name :
Dosage Strength : 2%; 0.1%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Intravenous Bag
Brand Name :
Dosage Strength : 1.5MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Intravenous Bag
Brand Name :
Dosage Strength : 1.8MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Film Coated Tablet
Brand Name :
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Film Coated Tablet
Brand Name :
Dosage Strength : 2.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Intravenous Vial
Brand Name :
Dosage Strength : 100MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Brand Name :
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Brand Name :
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Brand Name :
Dosage Strength : 12.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Brand Name :
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
2-Phenoxyethanol; Octenidine Hydrochloride
Dosage Form : Spray
Brand Name :
Dosage Strength : 2%; 0.1%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Intravenous Bag
Brand Name :
Dosage Strength : 1.5MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Intravenous Bag
Brand Name :
Dosage Strength : 1.8MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Film Coated Tablet
Brand Name :
Dosage Strength : 2.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Film Coated Tablet
Brand Name :
Dosage Strength : 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Intravenous Vial
Brand Name :
Dosage Strength : 100MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Brand Name :
Dosage Strength : 12.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Brand Name :
Dosage Strength : 25MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Brand Name :
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Regulatory Info :
Registration Country : Spain
Dosage Form : Tablet
Brand Name :
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
Services
API Manufacturing
Pharma Service : API Manufacturing
Category : Small Scale Batch
Sub Category : Overview
Pharma Service : API Manufacturing
Pharma Service : API Manufacturing
Category : Contract Manufacturing
Sub Category : Overview
Pharma Service : API Manufacturing
Sales, Marketing, Registration
Packaging
Inspections and registrations
District Decision : Voluntary Action Indicated
Inspection End Date : 2018-06-15
City : Celra
State :
Country/Area : Spain
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2018-06-15
District Decision : Voluntary Action Indicated
Inspection End Date : 2018-05-23
City : Hal Far, Birzebbuga
State :
Country/Area : Malta
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2018-05-23
District Decision : No Action Indicated
Inspection End Date : 2015-04-30
City : Celra
State :
Country/Area : Spain
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2015-04-30
District Decision : No Action Indicated
Inspection End Date : 2015-02-19
City : Hal Far, Birzebbuga
State :
Country/Area : Malta
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2015-02-19
District Decision : No Action Indicated
Inspection End Date : 2012-09-21
City : Celra
State :
Country/Area : Spain
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2012-09-21
District Decision : No Action Indicated
Inspection End Date : 2012-04-19
City : Hal Far, Birzebbuga
State :
Country/Area : Malta
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2012-04-19
District Decision : No Action Indicated
Inspection End Date : 2009-04-09
City : Celra
State :
Country/Area : Spain
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2009-04-09
ABOUT THIS PAGE
Medichem S.A is a supplier offers 92 products (APIs, Excipients or Intermediates).
Find a price of Clozapine bulk with DMF, CEP, JDMF offered by Medichem S.A
Find a price of Brimonidine Tartrate bulk with DMF, CEP offered by Medichem S.A
Find a price of Chlorhexidine Acetate bulk with DMF, CEP offered by Medichem S.A
Find a price of Chlorhexidine Gluconate bulk with DMF, CEP offered by Medichem S.A
Find a price of Chlorhexidine Hydrochloride bulk with DMF, CEP offered by Medichem S.A
Find a price of Felodipine bulk with DMF, CEP offered by Medichem S.A
Find a price of Mirtazapine bulk with DMF, CEP offered by Medichem S.A
Find a price of Paroxetine Hydrochloride bulk with DMF, CEP offered by Medichem S.A
Find a price of Quetiapine Hemifumarate bulk with DMF, CEP offered by Medichem S.A
Find a price of Rivaroxaban bulk with DMF, CEP offered by Medichem S.A
Find a price of Sugammadex Sodium bulk with DMF, JDMF offered by Medichem S.A
Find a price of Voriconazole bulk with DMF, CEP offered by Medichem S.A
Find a price of Chlorhexidine Gluconate bulk with DMF offered by Medichem S.A
Find a price of Adapalene bulk with DMF offered by Medichem S.A
Find a price of Alendronate Sodium bulk with CEP offered by Medichem S.A
Find a price of Ambrisentan bulk with DMF offered by Medichem S.A
Find a price of Amoxapine bulk with DMF offered by Medichem S.A
Find a price of Apixaban bulk with DMF offered by Medichem S.A
Find a price of Asenapine Maleate bulk with DMF offered by Medichem S.A
Find a price of Captopril bulk with DMF offered by Medichem S.A
Find a price of Chlorhexidine bulk with DMF offered by Medichem S.A
Find a price of Cinacalcet Hydrochloride bulk with DMF offered by Medichem S.A
Find a price of Cyclobenzaprine bulk with DMF offered by Medichem S.A
Find a price of Desvenlafaxine Succinate bulk with DMF offered by Medichem S.A
Find a price of Edaravone bulk with DMF offered by Medichem S.A
Find a price of Enalapril Maleate bulk with DMF offered by Medichem S.A
Find a price of Fluvoxamine bulk with DMF offered by Medichem S.A
Find a price of Gabapentin bulk with CEP offered by Medichem S.A
Find a price of Guanfacine bulk with DMF offered by Medichem S.A
Find a price of Lamotrigine bulk with DMF offered by Medichem S.A
Find a price of Lofexidine bulk with DMF offered by Medichem S.A
Find a price of Loxapine bulk with DMF offered by Medichem S.A
Find a price of Loxapine Succinate bulk with DMF offered by Medichem S.A
Find a price of Mexiletine bulk with DMF offered by Medichem S.A
Find a price of Micafungin bulk with DMF offered by Medichem S.A
Find a price of Nepafenac bulk with DMF offered by Medichem S.A
Find a price of Olopatadine Hydrochloride bulk with DMF offered by Medichem S.A
Find a price of Pantoprazole Sodium bulk with CEP offered by Medichem S.A
Find a price of Pazopanib Hydrochloride bulk with DMF offered by Medichem S.A
Find a price of Pimecrolimus bulk with DMF offered by Medichem S.A
Find a price of Prucalopride Succinate bulk with DMF offered by Medichem S.A
Find a price of Revefenacin bulk with DMF offered by Medichem S.A
Find a price of Risperidone bulk with CEP offered by Medichem S.A
Find a price of Rivaroxaban bulk with CEP offered by Medichem S.A
Find a price of Solifenacin Succinate bulk with CEP offered by Medichem S.A
Find a price of Sunitinib bulk with DMF offered by Medichem S.A
Find a price of Tamsulosin bulk with DMF offered by Medichem S.A
Find a price of Venlafaxine Hydrochloride bulk with CEP offered by Medichem S.A
Find a price of Voclosporin bulk with DMF offered by Medichem S.A
Find a price of VARENICLINE TARTRATE (MED-201890/E) bulk with DMF offered by Medichem S.A
Find a price of Amikacin bulk offered by Medichem S.A
Find a price of Brimonidine Tartrate bulk offered by Medichem S.A
Find a price of Buprenorphine bulk offered by Medichem S.A
Find a price of Cenobamate bulk offered by Medichem S.A
Find a price of Cinacalcet Hydrochloride bulk offered by Medichem S.A
Find a price of Clozapine bulk offered by Medichem S.A
Find a price of Dabigatran Etexilate Mesylate bulk offered by Medichem S.A
Find a price of Desvenlafaxine Succinate bulk offered by Medichem S.A
Find a price of Disodium Hydrogen Phosphate bulk offered by Medichem S.A
Find a price of Edaravone bulk offered by Medichem S.A
Find a price of Elexacaftor bulk offered by Medichem S.A
Find a price of Encorafenib bulk offered by Medichem S.A
Find a price of Glimepiride bulk offered by Medichem S.A
Find a price of Ivacaftor bulk offered by Medichem S.A
Find a price of Levoketoconazole bulk offered by Medichem S.A
Find a price of Lofexidine bulk offered by Medichem S.A
Find a price of Lorlatinib bulk offered by Medichem S.A
Find a price of Lumacaftor bulk offered by Medichem S.A
Find a price of Lumateperone Tosylate bulk offered by Medichem S.A
Find a price of Micafungin bulk offered by Medichem S.A
Find a price of Naloxone Hydrochloride bulk offered by Medichem S.A
Find a price of Naltrexone bulk offered by Medichem S.A
Find a price of Nepafenac bulk offered by Medichem S.A
Find a price of Octenidine Hydrochloride bulk offered by Medichem S.A
Find a price of Opicapone bulk offered by Medichem S.A
Find a price of Pazopanib Hydrochloride bulk offered by Medichem S.A
Find a price of Pimecrolimus bulk offered by Medichem S.A
Find a price of Potassium Phosphate bulk offered by Medichem S.A
Find a price of Quetiapine Hemifumarate bulk offered by Medichem S.A
Find a price of Rasagiline Tartrate bulk offered by Medichem S.A
Find a price of Relugolix bulk offered by Medichem S.A
Find a price of Rimegepant Sulfate bulk offered by Medichem S.A
Find a price of Ruxolitinib Phosphate bulk offered by Medichem S.A
Find a price of Sugammadex Sodium bulk offered by Medichem S.A
Find a price of Sunitinib bulk offered by Medichem S.A
Find a price of Tezacaftor bulk offered by Medichem S.A
Find a price of Varenicline Tartrate bulk offered by Medichem S.A
Find a price of Vibegron bulk offered by Medichem S.A
Find a price of Vildagliptin bulk offered by Medichem S.A
Find a price of Zanubrutinib bulk offered by Medichem S.A
Find a price of REVEFENACIN TRIHYDRATE bulk offered by Medichem S.A
Find a price of Opicaphone bulk offered by Medichem S.A