Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
01 2Hubei Gedian Humanwell Pharmaceutical
02 1LGM Pharma
03 1Metrochem API Private Limited
04 1Dr. Reddy's Laboratories
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01 1Argentina
02 6China
03 29India
04 2Italy
05 1Malta
06 1Switzerland
07 3U.S.A
01 9Active
02 8Inactive
03 26Blank
01 5Valid
02 2Withdrawn by Holder
03 36Blank
01 1229MF10186
02 1230MF10024
03 1230MF10161
04 1231MF10024
05 1231MF10062
06 1302MF10123
07 1306MF10087
08 36Blank
01 1WC-0017
02 1WC-0021n
03 1WC-0034
04 1WC-0041
05 1WC-0142A4-5
06 1WC-0419
07 37Blank
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-24
Pay. Date : 2021-04-02
DMF Number : 26803
Submission : 2013-01-09
Status : Active
Type : II
Certificate Number : R0-CEP 2020-298 - Rev 01
Issue Date : 2021-07-05
Type : Chemical
Substance Number : 2641
Status : Valid
NDC Package Code : 51508-006
Start Marketing Date : 2015-02-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2023-12-13
Registration Number : Su289-17-ND
Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : No. 25, Juxian Road, Gedian Economic Development District, E-Zhou City, Hubei Province, PR China
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-12
Pay. Date : 2012-11-30
DMF Number : 26475
Submission : 2012-10-03
Status : Active
Type : II
Date of Issue : 2022-06-15
Valid Till : 2025-06-16
Written Confirmation Number : WC-0034
Address of the Firm :
NDC Package Code : 55111-076
Start Marketing Date : 2012-08-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : JDW Pharmaceutical Co., Ltd.
Registration Date : 2018-08-14
Registration Number : No. 4692-3-ND(2)
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri Venkateswara Co-operative Industrial Estate Bollaram, Jinnaram Mandal, Sangareddy District, Telangana, 502325 INDIA
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27763
Submission : 2013-12-16
Status : Active
Type : II
NDC Package Code : 51508-006
Start Marketing Date : 2015-02-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2023-12-13
Registration Number : Su289-17-ND
Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : No. 25, Juxian Road, Gedian Economic Development District, E-Zhou City, Hubei Province, PR China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27011
Submission : 2013-03-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23494
Submission : 2010-04-30
Status : Inactive
Type : II
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