Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
01 2Hubei Gedian Humanwell Pharmaceutical
02 1LGM Pharma
03 1Dr. Reddy's Laboratories
04 1Jai Radhe Sales
05 1HRV Global Life Sciences
06 1Octavius Pharma Pvt. Ltd
07 1AASraw Biochemical Technology Co., Ltd
08 1Aspen Biopharma Labs
09 1Aspire Lifesciences Pvt Ltd
10 1Atomgrid
11 2Aurobindo Pharma Limited
12 2Cipla
13 2Curia
14 1DEAFARMA
15 1Gedeon Richter
16 1Hetero Drugs
17 1MSN Laboratories
18 1Nishchem International Pvt. Ltd
19 1Ryoto Fine Co
20 1Spansules Pharma
21 1Sterling Spa
22 1Sun Pharmaceutical Industries Limited
23 1Swati Spentose
24 1Synthland
25 1Unimax Group
26 1YUAN XINYAN
01 4China
02 1Hungary
03 18India
04 2Italy
05 1Japan
06 3U.S.A
07 1Blank
01 9Active
02 3Inactive
03 18Blank
01 1Expired
02 10Valid
03 19Blank
01 1226MF10054
02 1227MF10012
03 1227MF10060
04 1227MF10088
05 1230MF10079
06 1306MF10089
07 24Blank
01 1HB230032
02 1WC-0017
03 1WC-0021n
04 1WC-0034
05 1WC-0041
06 1WC-0142n
07 1WC-0143n
08 1WC-0159
09 22Blank
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-09-27
Pay. Date : 2022-08-04
DMF Number : 25056
Submission : 2011-06-17
Status : Active
Type : II
Certificate Number : R1-CEP 2013-238 - Rev 00
Issue Date : 2020-05-28
Type : Chemical
Substance Number : 1615
Status : Valid
Registration Number : 230MF10079
Registrant's Address : GEDIAN ECONOMIC DEVELOPMENT DISTRICT 436070, E-zhou, Hubei, China
Initial Date of Registration : 2018-07-05
Latest Date of Registration : --
Date of Issue : 2023-11-13
Valid Till : 2026-11-12
Written Confirmation Number : HB230032
Address of the Firm :
NDC Package Code : 51508-001
Start Marketing Date : 2012-07-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2014-07-25
Registration Number : 20140725-94-E-119-10
Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : No.25 Juxian Road, Gedian Economic Development District, E-zhou City, Hubei Province, China
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16010
Submission : 2002-06-11
Status : Active
Type : II
Certificate Number : R1-CEP 2009-195 - Rev 03
Issue Date : 2023-07-12
Type : Chemical
Substance Number : 1615
Status : Valid
Registration Number : 226MF10054
Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA
Initial Date of Registration : 2014-03-06
Latest Date of Registration : --
Date of Issue : 2022-06-15
Valid Till : 2025-06-16
Written Confirmation Number : WC-0034
Address of the Firm :
Registrant Name : Sangjin Corporation
Registration Date : 2008-11-28
Registration Number : 20081128-94-E-29-06
Manufacturer Name : Dr. Reddy's Laboratories Ltd.,
Manufacturer Address : Plot No. 110 & 111, SVCo.operative Industrial Estate, Bollaram Village, _x000D_ Jinnaram Mandal, Medak District, Telangana State
Octavius has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
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 : 29764
Submission : 2015-09-20
Status : Active
Type : II
NDC Package Code : 51508-001
Start Marketing Date : 2012-07-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2014-07-25
Registration Number : 20140725-94-E-119-10
Manufacturer Name : Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Manufacturer Address : No.25 Juxian Road, Gedian Economic Development District, E-zhou City, Hubei Province, China
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21300
Submission : 2008-01-24
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17575
Submission : 2004-07-26
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22675
Submission : 2009-05-14
Status : Inactive
Type : II
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