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 1DKSH
05 1ASG Biochem
06 1Aurisco Pharmaceutical
07 1Bayer AG
08 1CHEMO
09 1Cipla
10 1Curia
11 4Gedeon Richter
12 1Guangzhou Tosun Pharmaceutical
13 1Hangzhou Deli Chemical
14 2Industriale Chimica
15 1Lupin Ltd
16 2NEWCHEM SPA
17 1Nanjing Bold Chemical
18 1Qingdao Qingmei Biotech
19 1Sicor Societa Italiana Corticosteroidi Srl
20 1Sterling Spa
21 1Sun Pharmaceutical Industries Limited
22 1Swati Spentose
23 1Symbiotica Specialty Ingredients
24 1Teva API
25 1Teva Pharmaceutical Industries
26 1Zhejiang Xianju Junye Pharmaceutical Co. LTD
01 7China
02 1Germany
03 4Hungary
04 7India
05 2Israel
06 6Italy
07 1Malaysia
08 1Spain
09 1Switzerland
10 2U.S.A
01 10Active
02 22Blank
01 14Valid
02 1Withdrawn by Holder
03 17Blank
01 1303MF10024
02 1305MF10096
03 1305MF10112
04 1306MF10029
05 1306MF10044
06 27Blank
01 1WC-0161A2
02 1WC-0162
03 1WC-0168
04 29Blank
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
NDC Package Code : 51508-013
Start Marketing Date : 2022-03-09
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 32885
Submission : 2018-08-30
Status : Active
Type : II
Certificate Number : CEP 2018-118 - Rev 01
Issue Date : 2024-09-11
Type : Chemical
Substance Number : 2404
Status : Valid
Date of Issue : 2022-07-05
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm :
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17866
Submission : 2004-12-03
Status : Active
Type : II
Certificate Number : R0-CEP 2022-279 - Rev 00
Issue Date : 2022-12-01
Type : Chemical
Substance Number : 2404
Status : Valid
Registration Number : 305MF10112
Registrant's Address : BUDAPEST, GYOMROI UT 19-21, HUNGARY
Initial Date of Registration : 2023-09-26
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-04
Pay. Date : 2012-11-27
DMF Number : 22802
Submission : 2009-05-15
Status : Active
Type : II
Certificate Number : R0-CEP 2021-370 - Rev 01
Issue Date : 2023-07-21
Type : Chemical
Substance Number : 2404
Status : Valid
Registration Number : 306MF10044
Registrant's Address : Via San Vittore, 39 - 20123 Milano (Italy)
Initial Date of Registration : 2024-03-21
Latest Date of Registration : --
NDC Package Code : 24002-0002
Start Marketing Date : 2009-08-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-03-12
Registration Number : Number 133-13-ND
Manufacturer Name : NEWCHEM SpA@Microchem SRL
Manufacturer Address : Via Roveggia, 47, 37136 VERONA (VR), Italy@Via Turati, 2, 29017 Fiorenzuola d'Arda (PC) Italy
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-23
Pay. Date : 2012-11-08
DMF Number : 22878
Submission : 2009-06-18
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-08
Pay. Date : 2013-04-24
DMF Number : 21733
Submission : 2008-06-27
Status : Active
Type : II
Certificate Number : R1-CEP 2009-193 - Rev 00
Issue Date : 2015-08-20
Type : Chemical
Substance Number : 2404
Status : Valid
NDC Package Code : 64918-1401
Start Marketing Date : 2010-11-11
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 : 23580
Submission : 2010-08-16
Status : Active
Type : II
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
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