LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1HRV Global Life Sciences
03 1Apotex Pharmachem
04 2Aurisco Pharmaceutical
05 1CHEMO
06 1Guangzhou Topwork Chemical
07 1Guangzhou Tosun Pharmaceutical
08 1Hetero Drugs
09 2Industriale Chimica
10 1JPN Pharma
11 1MSN Laboratories
12 1Tecoland Corporation
13 1Zhejiang Pure Pharmaceutical
14 1Zhejiang Shenzhou Pharmaceutical
15 1Zhejiang Xianju Pharmaceutical Co. Ltd
01 1Canada
02 7China
03 4India
04 2Italy
05 1Spain
06 2U.S.A
01 6Active
02 1Inactive
03 10Blank
01 10Valid
02 7Blank
01 1304MF10019
02 1304MF10031
03 15Blank
01 1WC-0021n
02 1WC-0041
03 1WC-0336A3
04 14Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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 : 2025-12-31
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 : 19715
Submission : 2006-09-08
Status : Active
Type : II
Certificate Number : CEP 2024-299 - Rev 00
Issue Date : 2024-11-15
Type : Chemical
Substance Number : 2765
Status : Valid
NDC Package Code : 63190-0170
Start Marketing Date : 2006-09-08
End Marketing Date : 2025-12-31
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
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 : 2025-12-31
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 : 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
Certificate Number : CEP 2021-373 - Rev 00
Issue Date : 2024-04-19
Type : Chemical
Substance Number : 2765
Status : Valid
Date of Issue : 2022-03-07
Valid Till : 2024-12-16
Written Confirmation Number : WC-0336A3
Address of the Firm :
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