DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Shandong Loncom Pharmaceutical
03 1Sichuan Elixir Pharmaceuticals
04 1Alembic Pharmaceuticals Limited
05 1Hetero Drugs
06 1Jiangsu Lianhuan Pharmaceutical
07 2MSN Laboratories
01 3China
02 5India
01 4Active
02 4Blank
01 8Blank
01 8Blank
01 1WC-0349
02 7Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36697
Submission : 2022-02-28
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0107
Start Marketing Date : 2021-01-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-30
Pay. Date : 2023-01-09
DMF Number : 37585
Submission : 2022-11-30
Status : Active
Type : II
NDC Package Code : 54893-0107
Start Marketing Date : 2021-01-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-06-13
Pay. Date : 2023-04-25
DMF Number : 38274
Submission : 2023-05-02
Status : Active
Type : II
NDC Package Code : 68554-0140
Start Marketing Date : 2019-07-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-04-20
Pay. Date : 2023-03-30
DMF Number : 37912
Submission : 2023-03-30
Status : Active
Type : II
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