LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
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03 1Akums Lifesciences
04 1Amicogen China Biopharm Co. - Ltd
05 2Aurobindo Pharma Limited
06 1China Union Chempharma (Suzhou) Co.,Ltd
07 2Covalent Laboratories Private Limited
08 1Dhanuka Laboratories Ltd
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15 1Nectar Lifesciences
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20 1Qilu Pharmaceutical
21 1RANBAXY LABORATORIES LIMITED
22 1Sandoz B2B
23 1Sichuan Renan Pharmaceutical
24 1Suvan Lifesciences
25 1Suzhou Tianlu Bio-pharmaceutical Co., Ltd
26 1TAPI Technology & API Services
27 1TIANJIN GENCOM PHARMACEUTICAL CO LTD
28 1Virchow Group
29 1YUNGJIN PHARM. CO. LTD
30 1Zhejiang Apeloa Tospo Pharmaceutical Co. Ltd
01 10China
02 15India
03 1Israel
04 1Italy
05 3South Korea
06 1Switzerland
07 1U.S.A
01 11Active
02 1Inactive
03 20Blank
01 32Blank
01 1218MF10515
02 1223MF10020
03 1228MF10039
04 1228MF10044
05 1228MF10084
06 1230MF10109
07 26Blank
01 1WC-0120
02 1WC-0145
03 1WC-0190
04 1WC-0224
05 28Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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 : 29119
Submission : 2015-02-27
Status : Active
Type : II
Date of Issue : 2013-08-08
Valid Till : 2016-07-02
Written Confirmation Number : WC-0224
Address of the Firm :
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