Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
01 1Hubei Gedian Humanwell Pharmaceutical
02 3Symbiotec Pharmalab
03 1Axplora
04 1EUROAPI
05 1Sanofi
06 1Gonane Pharma
07 1ACS DOBFAR SPA
08 1Abbott Laboratories
09 1Bayer AG
10 1Biofer
11 1Curia
12 1Fujifilm Diosynth Biotechnologies
13 1Henan Lihua Pharmaceutical
14 1Mac-Chem Products (India) Pvt.Ltd
15 1Maharshi Pharma Chem
16 1NEWCHEM SPA
17 2Pfizer Inc
18 1Sicor Societa Italiana Corticosteroidi Srl
19 1Symbiotica Specialty Ingredients
20 1Teva Pharmaceutical Industries
21 1Tianjin Tianyao Pharmaceuticals Co., Ltd.
22 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 4China
02 2France
03 2Germany
04 6India
05 1Israel
06 4Italy
07 1Malaysia
08 4U.S.A
09 1United Kingdom
01 5Active
02 6Inactive
03 14Blank
01 7Valid
02 1Withdrawn by Holder
03 17Blank
01 1220MF10128
02 24Blank
01 1WC-0161
02 1WC-0161A2
03 1WC-0162
04 1WC-0485A3
05 21Blank
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
NDC Package Code : 51508-015
Start Marketing Date : 2024-04-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-03
Pay. Date : 2014-02-21
DMF Number : 22904
Submission : 2009-06-29
Status : Active
Type : II
Certificate Number : R1-CEP 2009-187 - Rev 04
Issue Date : 2023-01-30
Type : Chemical
Substance Number : 1131
Status : Valid
Date of Issue : 2022-09-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161
Address of the Firm :
NDC Package Code : 22552-0024
Start Marketing Date : 2011-08-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Certificate Number : CEP 2023-235 - Rev 00
Issue Date : 2024-03-06
Type : Chemical
Substance Number : 1131
Status : Valid
Available Reg Filing : EU |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-14
Pay. Date : 2014-01-06
DMF Number : 2922
Submission : 1977-05-02
Status : Active
Type : II
Certificate Number : R1-CEP 2005-228 - Rev 03
Issue Date : 2021-12-17
Type : Chemical
Substance Number : 1131
Status : Valid
Registration Number : 220MF10128
Registrant's Address : 82 Avenue Raspail 94250 Gentilly France
Initial Date of Registration : 2008-05-15
Latest Date of Registration : --
NDC Package Code : 82298-109
Start Marketing Date : 2011-02-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ROW |
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3779
Submission : 1980-04-15
Status : Inactive
Type : II
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162
Address of the Firm :
NDC Package Code : 22552-0024
Start Marketing Date : 2011-08-24
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 : 22552-0024
Start Marketing Date : 2011-08-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-06-22
Pay. Date : 2016-04-13
DMF Number : 30238
Submission : 2016-01-26
Status : Active
Type : II
Certificate Number : R0-CEP 2021-153 - Rev 00
Issue Date : 2022-09-27
Type : Chemical
Substance Number : 1131
Status : Valid
NDC Package Code : 57582-012
Start Marketing Date : 2021-06-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3601
Submission : 1979-08-06
Status : Inactive
Type : II
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