Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
01 1Hubei Gedian Humanwell Pharmaceutical
02 1Fareva
03 1Anhui HaiKang Pharmaceutical
04 1Aspen Biopharma Labs
05 1Aurobindo Pharma Limited
06 1Aurore Life Sciences
07 1Bakul Group
08 1CHANGZHOU KONY PHARMACEUTICAL CO., LTD. CN 213 105 Changzhou
09 1Charioteer
10 1Globe Quimica Ltda
11 1Hainan Poly Pharm
12 1Hetero Drugs
13 2RANBAXY LABORATORIES LIMITED
14 1Shouyuan Chemical
15 1Sibbiotech
16 1Sujalam Chemicals
17 1Trifarma
18 1Unimark Remedies Limited
19 1Unipex
01 1Brazil
02 6China
03 1France
04 9India
05 1Italy
06 1Luxembourg
07 1Russia
01 4Active
02 3Inactive
03 13Blank
01 2Valid
02 18Blank
01 1222MF10281
02 19Blank
01 1WC-0066
02 1WC-0170
03 18Blank
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-30
Pay. Date : 2013-01-08
DMF Number : 15567
Submission : 2001-07-31
Status : Active
Type : II
Certificate Number : R1-CEP 2010-257 - Rev 03
Issue Date : 2021-09-30
Type : Chemical
Substance Number : 1752
Status : Valid
Registration Number : 222MF10281
Registrant's Address : NUERNBERGER STRASSE 12, 90537 FEUCHT, GERMANY
Initial Date of Registration : 2010-12-24
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-02
Pay. Date : 2015-08-07
DMF Number : 28973
Submission : 2015-04-02
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23721
Submission : 2010-04-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-07
Pay. Date : 2017-02-15
DMF Number : 31402
Submission : 2017-02-18
Status : Active
Type : II
NDC Package Code : 59651-108
Start Marketing Date : 2024-01-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27133
Submission : 2013-05-02
Status : Inactive
Type : II
Certificate Number : R1-CEP 2013-123 - Rev 01
Issue Date : 2019-06-20
Type : Chemical
Substance Number : 1752
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16043
Submission : 2002-07-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19049
Submission : 2005-12-21
Status : Inactive
Type : II
Date of Issue : 2024-04-23
Valid Till : 2027-04-22
Written Confirmation Number : WC-0170
Address of the Firm :
Date of Issue : 2019-08-09
Valid Till : 2025-08-08
Written Confirmation Number : WC-0066
Address of the Firm :
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