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01 1Temad Co
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03 1Delta Finochem
04 1Fleming Laboratories
05 1Hainan Poly Pharm
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07 1Laboratori Alchemia Srl
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01 3Valid
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01 1217MF10883
02 1218MF10545
03 1219MF10162
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01 1WC-491n
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01 120071204-92-E-49-01
02 120080228-92-E-44-02
03 120080228-92-E-44-02(1)
04 120080627-92-E-71-03
05 120211123-92-E-165-04
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01 114799-2021
02 117337-0522
03 138779-2973
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05 151927-0148
06 162991-2967
07 164220-146
08 171052-377
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-02-22
Pay. Date : 2015-02-13
DMF Number : 16201
Submission : 2002-10-14
Status : Active
Type : II
Registration Number : 218MF10545
Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy
Initial Date of Registration : 2006-06-02
Latest Date of Registration :

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21687
Submission : 2008-06-11
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9440
Submission : 1991-11-11
Status : Inactive
Type : II

Certificate Number : CEP 2012-054 - Rev 05
Issue Date : 2025-03-17
Type : Chemical
Substance Number : 1592
Status : Valid
NDC Package Code : 17337-0522
Start Marketing Date : 2017-01-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Unimed Pharmaceutical Co., Ltd.
Registration Date : 2011-10-07
Registration Number : 20080228-92-E-44-02(1)
Manufacturer Name : Olon SpA
Manufacturer Address : Via Livelli 1, Frazione Mariano, 26852 Casaletto Lodigiano



Date of Issue : 2024-05-07
Valid Till : 2027-04-02
Written Confirmation Number : WC-491n
Address of the Firm :
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2021-11-23
Registration Number : 20211123-92-E-165-04
Manufacturer Name : Fleming Laboratories Limited
Manufacturer Address : Plot No. 152&160, Phase-V, IDA, Jeedimetla, Hyderabad., Jeedimetla Village, Quthbullapur Mandal, Medchal-Malkajgiri District PinCode 500055 Telangana State India

Certificate Number : R1-CEP 2004-269 - Rev 01
Issue Date : 2017-05-19
Type : Chemical
Substance Number : 1592
Status : Valid
Registration Number : 217MF10883
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2005-11-07
Latest Date of Registration :
NDC Package Code : 64220-146
Start Marketing Date : 2024-06-04
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Seongwoo Chemical Co., Ltd.
Registration Date : 2008-06-27
Registration Number : 20080627-92-E-71-03
Manufacturer Name : Zhejiang Huahai Pharmaceutical co., ltd
Manufacturer Address : Linhai 317024, Zhejiang

Certificate Number : R1-CEP 2003-034 - Rev 03
Issue Date : 2020-09-11
Type : Chemical
Substance Number : 1592
Status : Valid
Registration Number : 219MF10162
Registrant's Address : Via San Faustino, 68 20134 Milano-Italy
Initial Date of Registration : 2007-05-15
Latest Date of Registration :

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We have 19 companies offering Ketotifen fumarate (Zaditor)
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