LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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05 1Amicogen China Biopharm Co. - Ltd
06 2Aurobindo Pharma Limited
07 1China Union Chempharma (Suzhou) Co.,Ltd
08 2Covalent Laboratories Private Limited
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10 1Guangzhou Tosun Pharmaceutical
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18 1Orchid Pharma
19 1Parabolic Drugs
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21 1RANBAXY LABORATORIES LIMITED
22 1Sandoz B2B
23 1Sichuan Renan Pharmaceutical
24 1Suvan Lifesciences
25 1Suzhou Tianlu Bio-pharmaceutical Co., Ltd
26 1TIANJIN GENCOM PHARMACEUTICAL CO LTD
27 1Virchow Group
28 1YUNGJIN PHARM. CO. LTD
29 1Zhejiang Apeloa Tospo Pharmaceutical Co. Ltd
01 10China
02 14India
03 1Israel
04 1Italy
05 3South Korea
06 1Switzerland
07 1U.S.A
01 11Active
02 1Inactive
03 19Blank
01 31Blank
01 1218MF10515
02 1223MF10020
03 1228MF10039
04 1228MF10044
05 1228MF10084
06 1230MF10109
07 25Blank
01 1WC-0120
02 1WC-0145
03 1WC-0190
04 28Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20730
Submission : 2007-06-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29119
Submission : 2015-02-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19401
Submission : 2006-05-02
Status : Active
Type : II
Registration Number : 223MF10020
Registrant's Address : Orchid Towers, 313, Valluvar Kottam High Road, Nungambakkam, Chennai-600 034 India
Initial Date of Registration : 2011-02-08
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18457
Submission : 2005-06-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17986
Submission : 2004-12-01
Status : Active
Type : II
NDC Package Code : 17337-0302
Start Marketing Date : 2004-02-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-07
Pay. Date : 2016-10-19
DMF Number : 25882
Submission : 2012-03-19
Status : Active
Type : II
Date of Issue : 2019-09-03
Valid Till : 2022-09-03
Written Confirmation Number : WC-0190
Address of the Firm :
NDC Package Code : 61788-2000
Start Marketing Date : 2015-04-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2022-09-15
Registration Number : 20200714-209-J-690(1)
Manufacturer Name : Covalent Laboratories Private Limited
Manufacturer Address : Survey No. 374, Gundla Machanoor Village, Hathnoor Mandal, Sangareddy District Telangana State India 502 296
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-13
Pay. Date : 2016-07-19
DMF Number : 30320
Submission : 2016-02-22
Status : Active
Type : II
NDC Package Code : 61788-2000
Start Marketing Date : 2015-04-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Daewoong Bio Co., Ltd.
Registration Date : 2022-09-15
Registration Number : 20200714-209-J-690(1)
Manufacturer Name : Covalent Laboratories Private Limited
Manufacturer Address : Survey No. 374, Gundla Machanoor Village, Hathnoor Mandal, Sangareddy District Telangana State India 502 296
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19866
Submission : 2006-10-13
Status : Inactive
Type : II
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