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 1TAPI Technology & API Services
05 1Alembic Pharmaceuticals Limited
06 1Hetero Drugs
07 1Jiangsu Lianhuan Pharmaceutical
08 2MSN Laboratories
01 3China
02 5India
03 1Israel
01 4Active
02 5Blank
01 9Blank
01 9Blank
01 1WC-0349
02 8Blank
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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