LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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11 3U.S.A
01 13Active
02 3Inactive
03 18Blank
01 34Blank
01 34Blank
01 1WC-0027
02 1WC-0057n
03 1WC-0067
04 1WC-0079
05 1WC-0152
06 1WC-0157
07 1WC-0168
08 1WC-0182
09 1WC-0225
10 1WC-0317A2
11 1WC-0370
12 1WC-037a1
13 22Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm :
NDC Package Code : 55111-900
Start Marketing Date : 2010-01-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-08-20
Pay. Date : 2016-06-16
DMF Number : 30600
Submission : 2016-06-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22782
Submission : 2009-05-15
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-03
Pay. Date : 2012-12-20
DMF Number : 26599
Submission : 2012-12-21
Status : Active
Type : II
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm :
NDC Package Code : 66039-878
Start Marketing Date : 2013-05-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Chong Kun Dang Co., Ltd.
Registration Date : 2020-07-15
Registration Number : Su434-9-ND(4)
Manufacturer Name : Glenmark Life Sciences Limited.
Manufacturer Address : Plot No 3109, GIDC Industrial Estate, Ankleshwar - 393 002, Dist. Bharuch, Gujarat State, India
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-06
Pay. Date : 2013-02-21
DMF Number : 24159
Submission : 2010-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23687
Submission : 2010-05-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23707
Submission : 2010-05-10
Status : Inactive
Type : II
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17075
Submission : 2004-01-07
Status : Inactive
Type : II
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