LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1HRV Global Life Sciences
03 1Hubei Gedian Humanwell Pharmaceutical
04 1Apotex Pharmachem
05 2Aurisco Pharmaceutical
06 1CHEMO
07 1Guangzhou Topwork Chemical
08 1Guangzhou Tosun Pharmaceutical
09 1Hetero Drugs
10 2Industriale Chimica
11 1JPN Pharma
12 1MSN Laboratories
13 1Tecoland Corporation
14 1Zhejiang Pure Pharmaceutical
15 1Zhejiang Shenzhou Pharmaceutical
16 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 1Canada
02 8China
03 4India
04 2Italy
05 1Spain
06 2U.S.A
01 6Active
02 1Inactive
03 11Blank
01 9Valid
02 9Blank
01 1304MF10019
02 1304MF10031
03 16Blank
01 1WC-0021n
02 1WC-0041
03 1WC-0336A3
04 15Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-16
Pay. Date : 2019-09-24
DMF Number : 33832
Submission : 2019-05-20
Status : Active
Type : II
Certificate Number : CEP 2019-263 - Rev 02
Issue Date : 2024-03-05
Type : Chemical
Substance Number : 2765
Status : Valid
Registration Number : 304MF10031
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana INDIA
Initial Date of Registration : 2022-02-10
Latest Date of Registration : --
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0116
Start Marketing Date : 2002-09-27
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 : 19715
Submission : 2006-09-08
Status : Active
Type : II
Certificate Number : CEP 2017-004 - Rev 03
Issue Date : 2023-10-18
Type : Chemical
Substance Number : 2765
Status : Valid
NDC Package Code : 63190-0170
Start Marketing Date : 2006-09-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-15
Pay. Date : 2019-01-29
DMF Number : 32998
Submission : 2018-11-30
Status : Active
Type : II
NDC Package Code : 63190-0170
Start Marketing Date : 2006-09-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-14
Pay. Date : 2013-12-04
DMF Number : 23466
Submission : 2010-01-20
Status : Active
Type : II
Certificate Number : R1-CEP 2015-312 - Rev 02
Issue Date : 2022-10-06
Type : Chemical
Substance Number : 2765
Status : Valid
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0007
Start Marketing Date : 2010-03-24
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 : 37024
Submission : 2022-07-13
Status : Active
Type : II
Certificate Number : CEP 2022-244 - Rev 00
Issue Date : 2024-02-16
Type : Chemical
Substance Number : 2765
Status : Valid
NDC Package Code : 16637-0060
Start Marketing Date : 2022-06-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-30
Pay. Date : 2013-12-02
DMF Number : 27672
Submission : 2013-12-25
Status : Active
Type : II
Certificate Number : R1-CEP 2015-268 - Rev 00
Issue Date : 2021-01-06
Type : Chemical
Substance Number : 2765
Status : Valid
Registration Number : 304MF10019
Registrant's Address : Badu Industrial Park Zone, Tiantai, Zhejiang province, 317200, P. R. China
Initial Date of Registration : 2022-01-26
Latest Date of Registration : --
NDC Package Code : 16812-001
Start Marketing Date : 2020-01-01
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 : 19796
Submission : 2006-09-25
Status : Inactive
Type : II
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