Aspen API. More than just an API™
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01 1Aspen API
02 3Symbiotec Pharmalab
03 1Gonane Pharma
04 1Pfizer CentreOne
05 1AASraw Biochemical Technology Co., Ltd
06 1ASG Biochem
07 2Bayer AG
08 1F.I.S. Fabbrica Italiana Sintetici
09 1Fagron Group
10 1Hubei Gedian Humanwell Pharmaceutical
11 1Hubei Zhuxi Humanwell Pharmaceutical
12 1Ipca Laboratories
13 1Letco Medical
14 1Micro-Macinazione SA
15 1Pfizer Inc
16 1Productos Quimicos Naturales
17 1Shakti Lifescience
18 1Steroid SpA
19 1Sun Pharmaceutical Industries Limited
20 1Swati Spentose
21 1Symbiotica
22 1VM Life Science
23 1Zhejiang Xianju Pharmaceutical Co. Ltd
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01 4China
02 2Germany
03 10India
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06 1Mexico
07 2Netherlands
08 1Switzerland
09 3U.S.A
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01 8Active
02 18Blank
01 26Blank
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01 1WC-0161A2
02 2WC-0162A2
03 1WC-0168
04 1WC-0402
05 21Blank
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01 120220419-210-J-1271
02 120230612-210-J-1510
03 120230612-210-J-1510(A)
04 120240103-210-J-1588
05 22Blank
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01 10009-5036
02 110745-1444
03 112875-1080
04 122552-0013
05 148087-0135
06 149803-003
07 151552-1598
08 160722-3007
09 160870-0465
10 162991-3208
11 170492-005
12 173774-008
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01 26Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-04-26
Pay. Date : 2015-09-24
DMF Number : 14540
Submission : 1999-11-18
Status : Active
Type : II
NDC Package Code : 60870-0465
Start Marketing Date : 1999-11-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Synex Co., Ltd.
Registration Date : 2024-01-03
Registration Number : 20240103-210-J-1588
Manufacturer Name : Aspen Oss BV
Manufacturer Address : Veersemeer 4, 5347 JN Oss, The Netherlands
Available Reg Filing : ASMF, BR |
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-02
Pay. Date : 2023-10-03
DMF Number : 25534
Submission : 2011-11-28
Status : Active
Type : II
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
NDC Package Code : 22552-0013
Start Marketing Date : 2010-04-29
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Unimed Pharmaceutical Co., Ltd.
Registration Date : 2024-03-04
Registration Number : 20230612-210-J-1510(A)
Manufacturer Name : Symbiotec Pharmalab Private Limited
Manufacturer Address : Plot No: 5, 6, 7 & 8, Special Economic Zone, Phase-II, Pharma zone, Pithampur, Dist. Dhar - 454 774(MP), India
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-24
Pay. Date : 2016-05-02
DMF Number : 24500
Submission : 2011-03-01
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162A2
Address of the Firm :
Registrant Name : Lucefarm Co., Ltd.
Registration Date : 2023-06-12
Registration Number : 20230612-210-J-1510
Manufacturer Name : Symbiotec Pharmalab Pvt. Ltd.
Manufacturer Address : Plot No. 5, 6, 7 & 8, Special Economic Zone, Phase-II, Pharma Zone, Pithampur, Dist. Dhar - 454 774, (MP), INDIA
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27531
Submission : 2013-09-26
Status : Active
Type : II
NDC Package Code : 49803-003
Start Marketing Date : 2016-02-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25000g/25000g)
Marketing Category : BULK INGREDIENT
Registrant Name : Chong Kun Dang Co., Ltd.
Registration Date : 2022-04-19
Registration Number : 20220419-210-J-1271
Manufacturer Name : Steroid SpA
Manufacturer Address : Viale Spagna, 156 - 20093 Cologno Monese (MI), Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16795
Submission : 2003-08-15
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-04-11
Pay. Date : 2025-02-12
DMF Number : 40120
Submission : 2024-08-23
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-01
Pay. Date : 2013-07-18
DMF Number : 23934
Submission : 2010-06-28
Status : Active
Type : II
NDC Package Code : 60722-3007
Start Marketing Date : 2020-11-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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