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28-30 October, 2025
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05-07 October, 2025
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05-08 October, 2025
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6725
Submission : 1986-12-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11167
Submission : 1994-10-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8874
Submission : 1990-12-04
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-07
Pay. Date : 2014-01-29
DMF Number : 8584
Submission : 1990-05-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13215
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-02
Pay. Date : 2017-11-06
DMF Number : 32119
Submission : 2017-10-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-09-04
Pay. Date : 2020-07-14
DMF Number : 34915
Submission : 2020-06-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9443
Submission : 1991-11-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17951
Submission : 2004-12-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6084
Submission : 1985-11-04
Status : Inactive
Type : II
CEP/COS
Certificate Numbers : R1-CEP 1998-126 - Rev 03
Status : Valid
Issue Date : 2017-04-27
Type : Chemical
Substance Number : 968
CEP/COS
Certificate Numbers : R1-CEP 2013-228 - Rev 02
Status : Valid
Issue Date : 2020-06-11
Type : Chemical
Substance Number : 2573
CEP/COS
Certificate Numbers : R1-CEP 2016-160 - Rev 00
Status : Valid
Issue Date : 2021-11-17
Type : Chemical
Substance Number : 2591
CEP/COS
Certificate Numbers : CEP 2004-199 - Rev 07
Status : Valid
Issue Date : 2023-12-06
Type : Chemical
Substance Number : 1089
CEP/COS
Certificate Numbers : CEP 1999-096 - Rev 09
Status : Valid
Issue Date : 2024-10-30
Type : Chemical
Substance Number : 888
CEP/COS
Certificate Numbers : CEP 2021-219 - Rev 03
Status : Valid
Issue Date : 2024-10-30
Type : Chemical
Substance Number : 1089
Certificate Numbers : CEP 2023-283 - Rev 00
Status : Valid
Issue Date : 2024-12-18
Type : Chemical
Substance Number : 2787
Certificate Numbers : CEP 2023-220 - Rev 00
Status : Valid
Issue Date : 2024-10-21
Type : Chemical
Substance Number : 2372
CEP/COS
Certificate Numbers : R1-CEP 1999-139 - Rev 03
Status : Withdrawn by Holder
Issue Date : 2016-12-09
Type : Chemical
Substance Number : 1335
CEP/COS
Certificate Numbers : R1-CEP 2016-006 - Rev 00
Status : Valid
Issue Date : 2021-04-16
Type : Chemical
Substance Number : 1335
Registration Number : 217MF11306
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2005-12-22
Latest Date of Registration : 2022-02-10
JDMF
Registration Number : 227MF10091
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2015-03-12
Latest Date of Registration : 2015-03-12
JDMF
Registration Number : 218MF10922
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2006-11-21
Latest Date of Registration : 2006-11-21
JDMF
Registration Number : 306MF10038
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2024-03-06
Latest Date of Registration : 2024-03-06
Registration Number : 227MF10293
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2015-12-24
Latest Date of Registration : 2017-01-31
JDMF
Registration Number : 220MF10029
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2008-01-23
Latest Date of Registration : 2021-11-10
JDMF
Registration Number : 230MF10154
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2018-11-14
Latest Date of Registration : 2021-11-10
JDMF
Registration Number : 226MF10016
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2014-01-21
Latest Date of Registration : 2014-01-21
JDMF
Registration Number : 226MF10194
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2014-09-30
Latest Date of Registration : 2014-09-30
JDMF
Registration Number : 218MF10191
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2006-02-08
Latest Date of Registration : 2021-11-10
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2007-12-28
Registration Number : 20071228-85-D-47-06
Manufacturer Name : Quimica Sintetica SA
Manufacturer Address : C/Dulcinea s/n 28805 Alcala de Henares Madrid spain
Registrant Name : Sandoz Korea Co., Ltd.
Registration Date : 2005-09-15
Registration Number : 20050915-74-A-170-12
Manufacturer Name : Quimica Sintecica SA
Manufacturer Address : C/Dulcinea s/n 28805 Alcala de Henares Madridm spain
Registrant Name : Huons Co., Ltd.
Registration Date : 2007-12-04
Registration Number : 20071204-61-C-230-06
Manufacturer Name : Quimica sintetica sa
Manufacturer Address : C/dulcinea, s/n 28805 alcala de henares madrid
Registrant Name : Base Farm Co., Ltd.
Registration Date : 2019-05-13
Registration Number : 20071204-61-C-230-06(6)
Manufacturer Name : Quimica Sintetica SA
Manufacturer Address : 28805, C/ Dulcinea s/n, Alcala de Henares, Madrid, Spain
Registrant Name : Dongkwang Pharmaceutical Co., Ltd.
Registration Date : 2011-06-15
Registration Number : 20071204-61-C-230-06(1)
Manufacturer Name : Quimica sintetica sa
Manufacturer Address : C/dulcinea, s/n 28805 alcala de henares madrid
Registrant Name : Hwaduk Pharmaceutical Co., Ltd.
Registration Date : 2013-08-28
Registration Number : 20071204-61-C-230-06(3)
Manufacturer Name : Quimica sintetica sa
Manufacturer Address : C/dulcinea, s/n 28805 alcala de henares madrid, Spain.
Registrant Name : Pharma Solution Co., Ltd.
Registration Date : 2018-02-08
Registration Number : 20071204-61-C-230-06(5)
Manufacturer Name : Quimica sintetica sa
Manufacturer Address : C/dulcinea, s/n 28805 alcala de henares madrid
Registrant Name : Taejun Pharmaceutical Co., Ltd.
Registration Date : 2020-12-17
Registration Number : 20201217-3-B-438-21
Manufacturer Name : Quimica Sintetica SA
Manufacturer Address : C/ Dulcinea s/n, Alcala de Henares, 28805 Madrid, Spain
Registrant Name : Dongkwang Pharmaceutical Co., Ltd.
Registration Date : 2016-01-14
Registration Number : 20121218-135-H-205-34(2)
Manufacturer Name : Quimica Sintetica SA
Manufacturer Address : C/ Dulcinea s/n, 28805 Alcala de Henares, Madrid (Spain)
Registrant Name : Palmsgen Co., Ltd.
Registration Date : 2015-12-22
Registration Number : 20121218-135-H-205-34(1)
Manufacturer Name : Quimica Sintetica SA
Manufacturer Address : C/U Dulcinea sn, 28805 Alcala de henares, Madrid (Spain)
NDC Package Code : 53069-0440
Start Marketing Date : 2000-03-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53069-1030
Start Marketing Date : 2018-05-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53069-0120
Start Marketing Date : 1998-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53069-0720
Start Marketing Date : 1998-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53069-1040
Start Marketing Date : 2014-03-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53069-1050
Start Marketing Date : 2014-03-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53069-1010
Start Marketing Date : 2009-05-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53069-0150
Start Marketing Date : 1990-03-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53069-0920
Start Marketing Date : 1999-02-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53069-0010
Start Marketing Date : 1999-02-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Inspections and registrations
Type : GMP Certificates
Number : ES/049/12
EudraGMDP Key : 11901
Country : Spain
Issue Date : 2012-03-20
Post Code : 28805
NCA Ref : 43101
City : Alcala de Henares
ABOUT THIS PAGE
Quimica Sintetica is a supplier offers 115 products (APIs, Excipients or Intermediates).
Find a price of Omeprazole bulk with DMF, CEP, JDMF offered by Quimica Sintetica
Find a price of Ciprofloxacin Hydrochloride bulk with CEP, JDMF offered by Quimica Sintetica
Find a price of Lansoprazole bulk with CEP, JDMF offered by Quimica Sintetica
Find a price of Acyclovir bulk with DMF, CEP offered by Quimica Sintetica
Find a price of Ciprofloxacin bulk with DMF, CEP offered by Quimica Sintetica
Find a price of Famotidine bulk with DMF, JDMF offered by Quimica Sintetica
Find a price of Fluconazole bulk with DMF, JDMF offered by Quimica Sintetica
Find a price of Guanfacine bulk with DMF, JDMF offered by Quimica Sintetica
Find a price of Itraconazole bulk with DMF, CEP offered by Quimica Sintetica
Find a price of Miconazole Nitrate bulk with DMF, CEP offered by Quimica Sintetica
Find a price of Ofloxacin bulk with DMF, CEP offered by Quimica Sintetica
Find a price of Pantoprazole Sodium bulk with DMF, CEP offered by Quimica Sintetica
Find a price of Rabeprazole Sodium bulk with CEP, JDMF offered by Quimica Sintetica
Find a price of Rivaroxaban bulk with DMF, CEP offered by Quimica Sintetica
Find a price of Sumatriptan bulk with DMF, CEP offered by Quimica Sintetica
Find a price of Terbinafine Hydrochloride bulk with DMF, CEP offered by Quimica Sintetica
Find a price of Famotidine bulk with JDMF offered by Quimica Sintetica
Find a price of Loratadine bulk with CEP offered by Quimica Sintetica
Find a price of Ranitidine Hydrochloride bulk with JDMF offered by Quimica Sintetica
Find a price of Apremilast bulk with DMF offered by Quimica Sintetica
Find a price of Benznidazole bulk with DMF offered by Quimica Sintetica
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Find a price of Captopril bulk with DMF offered by Quimica Sintetica
Find a price of Celecoxib bulk with CEP offered by Quimica Sintetica
Find a price of Chloramphenicol Succinate Acid bulk with DMF offered by Quimica Sintetica
Find a price of Ciprofloxacin bulk with CEP offered by Quimica Sintetica
Find a price of Ciprofloxacin Hydrochloride bulk with DMF offered by Quimica Sintetica
Find a price of Droxidopa bulk with DMF offered by Quimica Sintetica
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Find a price of Eltrombopag bulk with DMF offered by Quimica Sintetica
Find a price of Esomeprazole Magnesium bulk with CEP offered by Quimica Sintetica
Find a price of Fluoxetine Hydrochloride bulk with DMF offered by Quimica Sintetica
Find a price of Fosfomycin Trometamol bulk with DMF offered by Quimica Sintetica
Find a price of Indapamide bulk with DMF offered by Quimica Sintetica
Find a price of Itraconazole bulk offered by Quimica Sintetica
Find a price of Ketoconazole bulk with DMF offered by Quimica Sintetica
Find a price of Ketorolac Trometamol bulk with DMF offered by Quimica Sintetica
Find a price of Lansoprazole bulk with JDMF offered by Quimica Sintetica
Find a price of Levofloxacin Hemihydrate bulk with CEP offered by Quimica Sintetica
Find a price of Loratadine bulk with DMF offered by Quimica Sintetica
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Find a price of Posaconazole bulk with DMF offered by Quimica Sintetica
Find a price of Praziquantel bulk with CEP offered by Quimica Sintetica
Find a price of Rabeprazole Sodium bulk with JDMF offered by Quimica Sintetica
Find a price of Spinosyn D bulk with DMF offered by Quimica Sintetica
Find a price of Tamsulosin bulk with CEP offered by Quimica Sintetica
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Find a price of Tianeptine Sodium bulk with CEP offered by Quimica Sintetica
Find a price of Venlafaxine Hydrochloride bulk with CEP offered by Quimica Sintetica
Find a price of Isradipine, Micronised, non-micronised bulk with CEP offered by Quimica Sintetica
Find a price of Rivaroxaban, Process II, Non-micronised and Micronised bulk with CEP offered by Quimica Sintetica
Find a price of Indapamide, Non-micronised, Micronised bulk with CEP offered by Quimica Sintetica
Find a price of 6-Aminopenicillanic Acid bulk offered by Quimica Sintetica
Find a price of Acebutolol Hydrochloride bulk offered by Quimica Sintetica
Find a price of Amoxicillin Trihydrate bulk offered by Quimica Sintetica
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Find a price of Azithromycin bulk offered by Quimica Sintetica
Find a price of Beclomethasone Dipropionate bulk offered by Quimica Sintetica
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Find a price of Betamethasone Acetate bulk offered by Quimica Sintetica
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Find a price of Hydrocortisone Sodium Succinate bulk offered by Quimica Sintetica
Find a price of Irbesartan bulk offered by Quimica Sintetica
Find a price of Ketoconazole bulk offered by Quimica Sintetica
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Find a price of Levofloxacin bulk offered by Quimica Sintetica
Find a price of Levofloxacin Hemihydrate bulk offered by Quimica Sintetica
Find a price of Loperamide Hydrochloride bulk offered by Quimica Sintetica
Find a price of Meclofenamic Acid bulk offered by Quimica Sintetica
Find a price of Mefenamic Acid bulk offered by Quimica Sintetica
Find a price of Methylprednisolone bulk offered by Quimica Sintetica
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Find a price of Prednisolone Sodium Phosphate bulk offered by Quimica Sintetica
Find a price of Progesterone bulk offered by Quimica Sintetica
Find a price of Ranitidine Hydrochloride bulk offered by Quimica Sintetica
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Find a price of Venlafaxine Hydrochloride bulk offered by Quimica Sintetica
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Find a price of FACIL, PERSONNEL AND GENL OPERATING PROCEDURES AT MADRID,SPAIN bulk offered by Quimica Sintetica
Find a price of Abiraterone Acetate bulk offered by Quimica Sintetica
Find a price of Acyclovir bulk offered by Quimica Sintetica
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Find a price of Chloramphenicol Succinate Acid bulk offered by Quimica Sintetica
Find a price of Ciprofloxacin Hydrochloride bulk offered by Quimica Sintetica
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Find a price of Indapamide bulk offered by Quimica Sintetica
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Find a price of Ketorolac Trometamol bulk offered by Quimica Sintetica
Find a price of Milnacipran HCl bulk offered by Quimica Sintetica
Find a price of Omeprazole bulk offered by Quimica Sintetica
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Find a price of Zopiclone bulk offered by Quimica Sintetica
Find a price of CHLORODIFLUOROQUINOLONE (CDFQ) bulk offered by Quimica Sintetica