Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
01 2Hubei Gedian Humanwell Pharmaceutical
02 2Pfizer CentreOne
03 2Symbiotec Pharmalab
04 1LGM Pharma
05 1Aspen API
06 1Gonane Pharma
07 1HRV Global Life Sciences
08 2ACS DOBFAR SPA
09 1ASG Biochem
10 1Actavis Inc
11 1Balaji Corporation
12 1Biotechnica DWC
13 2Catalent Pharma Solutions
14 1Chemo Biosynthesis
15 1Dishman Carbogen Amcis
16 1F.I.S. Fabbrica Italiana Sintetici
17 1Guangzhou Tosun Pharmaceutical
18 1Hangzhou Deli Chemical
19 1Hubei Vanz Pharm
20 2IPS International Products & Services srl
21 1Industriale Chimica
22 1JiangXi Hongyuan Pharmaceutical Material
23 2Jiangsu Jiaerke Pharmaceuticals Group
24 1Laboratoires Besins International
25 2Laboratorio Syntex S.A
26 1Mortar & Pestle
27 1Naari
28 1Organon
29 1Pfizer Inc
30 1Productos Quimicos Naturales
31 1Quimica Sintetica
32 1SAFIC-ALCAN group
33 1SIGMA TAU
34 1Shaanxi Hanjiang pharmaceutical Group Co
35 1Signa S.A. de C.V.
36 1Tecoland Corporation
37 1VM Life Science
38 2Zhejiang Shenzhou Pharmaceutical
39 2Zhejiang Xianju Pharmaceutical Co. Ltd
40 1Zhejiang Xianju Xianming Pharmaceutical
41 2Blank
01 1Algeria
02 2Argentina
03 14China
04 1France
05 10India
06 1Ireland
07 7Italy
08 2Mexico
09 1Netherlands
10 1Spain
11 1Thailand
12 9U.S.A
13 2Blank
01 13Active
02 15Inactive
03 24Blank
01 15Valid
02 3Withdrawn by Holder
03 34Blank
01 1225MF10081
02 1226MF10215
03 1227MF10021
04 1304MF10065
05 48Blank
01 1HB230032
02 1WC-0161A2
03 1WC-0162
04 49Blank
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-10-25
Pay. Date : 2018-07-27
DMF Number : 27668
Submission : 2013-11-01
Status : Active
Type : II
Certificate Number : R1-CEP 2013-328 - Rev 00
Issue Date : 2020-05-26
Type : Chemical
Substance Number : 429
Status : Valid
Date of Issue : 2023-11-13
Valid Till : 2026-11-12
Written Confirmation Number : HB230032
Address of the Firm :
NDC Package Code : 51508-002
Start Marketing Date : 2012-07-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-06
Pay. Date : 2013-02-14
DMF Number : 1418
Submission : 1969-09-04
Status : Active
Type : II
Certificate Number : CEP 2005-299 - Rev 03
Issue Date : 2024-04-03
Type : Chemical
Substance Number : 429
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-11
Pay. Date : 2019-06-10
DMF Number : 32709
Submission : 2018-04-03
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 : 22552-0049
Start Marketing Date : 2018-08-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-14
Pay. Date : 2019-05-09
DMF Number : 3823
Submission : 1980-05-20
Status : Active
Type : II
Certificate Number : R2-CEP 1996-017 - Rev 05
Issue Date : 2015-04-13
Type : Chemical
Substance Number : 429
Status : Valid
Registration Number : 227MF10021
Registrant's Address : Kloosterstraat 6, 5349 AB Oss, the Netherlands
Initial Date of Registration : 2015-01-05
Latest Date of Registration : --
NDC Package Code : 60870-0248
Start Marketing Date : 1980-04-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : Synex Co., Ltd.
Registration Date : 2023-12-26
Registration Number : 20231226-210-J-1589
Manufacturer Name : Aspen Oss BV
Manufacturer Address : Veersemeer 4, 5347 JN Oss, The Netherlands
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 : Reviewed
Rev. Date : 2021-03-11
Pay. Date : 2021-01-12
DMF Number : 33003
Submission : 2018-07-25
Status : Active
Type : II
Certificate Number : CEP 2018-166 - Rev 03
Issue Date : 2024-08-20
Type : Chemical
Substance Number : 429
Status : Valid
NDC Package Code : 51508-002
Start Marketing Date : 2012-07-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-03
Pay. Date : 2018-03-16
DMF Number : 32099
Submission : 2017-12-28
Status : Active
Type : II
Certificate Number : R0-CEP 2018-200 - Rev 01
Issue Date : 2022-02-02
Type : Chemical
Substance Number : 429
Status : Valid
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm :
NDC Package Code : 22552-0049
Start Marketing Date : 2018-08-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
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