Aspen API. More than just an API.
01 1Aspen API
02 2Symbiotec Pharmalab
03 1Hubei Gedian Humanwell Pharmaceutical
04 1Gonane Pharma
05 1Hubei Zhuxi Humanwell Pharmaceutical
06 1Pfizer CentreOne
07 1AASraw Biochemical Technology Co., Ltd
08 1ASG Biochem
09 2Bayer AG
10 1Ipca Laboratories
11 1Steroid SpA
12 1Sun Pharmaceutical Industries Limited
13 1Swati Spentose
14 1VM Life Science
15 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 4China
02 2Germany
03 8India
04 1Italy
05 1Netherlands
06 1U.S.A
01 8Active
02 9Blank
01 17Blank
01 17Blank
01 1WC-0161A2
02 1WC-0162
03 1WC-0168
04 1WC-0402
05 13Blank
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 : 2024-12-31
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
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-0162
Address of the Firm :
NDC Package Code : 22552-0013
Start Marketing Date : 2010-04-29
End Marketing Date : 2024-12-31
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
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
NDC Package Code : 70492-005
Start Marketing Date : 2024-05-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40120
Submission : 2024-08-23
Status : Active
Type : II
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 : 2022-07-05
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 : 2024-12-31
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 : 2024-12-31
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 : 2024-12-31
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
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