Aspen API. More than just an API.
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 1Hubei Zhuxi Humanwell Pharmaceutical
09 1Ipca Laboratories
10 1Steroid SpA
11 1Sun Pharmaceutical Industries Limited
12 1Swati Spentose
13 1VM Life Science
14 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 3China
02 2Germany
03 9India
04 1Italy
05 1Netherlands
06 1U.S.A
01 8Active
02 9Blank
01 17Blank
01 17Blank
01 1WC-0161A2
02 2WC-0162A2
03 1WC-0168
04 1WC-0402
05 12Blank
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 :
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
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
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
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 : 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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16795
Submission : 2003-08-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40120
Submission : 2024-08-23
Status : Active
Type : II
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