LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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01 151686-0007
02 155111-902
03 155486-1572
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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.
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NDC Package Code : 55111-902
Start Marketing Date : 2009-03-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-12-17
Pay. Date : 2023-06-05
DMF Number : 36925
Submission : 2023-05-22
Status : Active
Type : II
Certificate Number : CEP 2021-437 - Rev 01
Issue Date : 2025-10-10
Type : Chemical
Substance Number : 2288
Status : Valid
NDC Package Code : 51686-0007
Start Marketing Date : 2024-01-03
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : EU DMF |
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
NDC Package Code : 55486-1572
Start Marketing Date : 2012-06-03
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23979
Submission : 2010-07-19
Status : Active
Type : II
Certificate Number : R1-CEP 2011-214 - Rev 00
Issue Date : 2017-09-14
Type : Chemical
Substance Number : 2288
Status : Valid

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25065
Submission : 2011-06-16
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17511
Submission : 2004-07-01
Status : Inactive
Type : II

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