Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
01 1Hubei Gedian Humanwell Pharmaceutical
02 1LGM Pharma
03 2Symbiotec Pharmalab
04 13M Drug Delivery Systems
05 1ASG Biochem
06 1Arudavis Labs
07 1Balaji Corporation
08 4Bayer AG
09 1CHEMO
10 1Cipla
11 1FORTEQ NIDAU AG
12 1Formosa Laboratories
13 3Gedeon Richter
14 1Guangzhou Tosun Pharmaceutical
15 1Hangzhou Longshine Bio-Tech
16 1Hunan KYX Pharmaceutical
17 1Indo Phyto Chemicals Private Ltd
18 1Industriale Chimica
19 1Jenapharm GmbH & Co KG DE 07745 Jena
20 1Jiangsu Lianhuan Pharmaceutical
21 2Lupin Ltd
22 1Naari
23 3Qinhuangdao Zizhu Pharmaceutical
24 2ScinoPharm Taiwan, Ltd
25 2Sterling Spa
26 2Swati Spentose
27 1Yangzhou Pharmaceutical Factory
28 5Blank
01 9China
02 5Germany
03 3Hungary
04 12India
05 3Italy
06 1Spain
07 1Switzerland
08 3Taiwan
09 2U.S.A
10 5Blank
01 18Active
02 10Inactive
03 16Blank
01 9Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 1Withdrawn by Holder
04 33Blank
01 1218MF10828
02 1221MF10183
03 1221MF10292
04 1228MF10159
05 40Blank
01 1HB230032
02 1WC-0161A2
03 1WC-0162
04 1WC-0297
05 1WC-297
06 39Blank
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-12-02
Pay. Date : 2022-08-15
DMF Number : 33000
Submission : 2022-06-24
Status : Active
Type : II
Certificate Number : R0-CEP 2022-199 - Rev 00
Issue Date : 2023-05-19
Type : Chemical
Substance Number : 926
Status : Valid
Date of Issue : 2023-11-13
Valid Till : 2026-11-12
Written Confirmation Number : HB230032
Address of the Firm :
NDC Package Code : 51508-012
Start Marketing Date : 2022-03-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-23
Pay. Date : 2014-01-23
DMF Number : 27867
Submission : 2014-01-27
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 : 22552-0047
Start Marketing Date : 2017-06-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
NDC Package Code : 22552-0047
Start Marketing Date : 2017-06-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8806
Submission : 1990-10-30
Status : Active
Type : II
Certificate Number : R1-CEP 1999-141 - Rev 04
Issue Date : 2021-12-20
Type : Chemical
Substance Number : 926
Status : Valid
NDC Package Code : 45541-1149
Start Marketing Date : 2001-07-17
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 : 9136
Submission : 1991-05-20
Status : Active
Type : II
NDC Package Code : 45541-1149
Start Marketing Date : 2001-07-17
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 : 35419
Submission : 2020-12-16
Status : Active
Type : II
NDC Package Code : 45541-1149
Start Marketing Date : 2001-07-17
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 : 14923
Submission : 2000-06-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26830
Submission : 2013-01-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12934
Submission : 1998-03-20
Status : Inactive
Type : II
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