DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1Egis Pharmaceuticals PLC
03 1Aarti Pharmalabs
04 1Sichuan Elixir Pharmaceuticals
05 1Alembic Pharmaceuticals Limited
06 1Beijing Mesochem Technology
07 1Beijing Sjar Technology Development
08 2Cipla
09 1Hangzhou Longshine Bio-Tech
10 1Hetero Drugs
11 3MSN Laboratories
12 1Natco Pharma
13 1Teva API
14 1Zhejiang Tianyu Pharmaceutical Co., Ltd
01 5China
02 1Hungary
03 10India
04 1Israel
01 8Active
02 9Blank
01 17Blank
01 17Blank
01 1WC-0349
02 16Blank
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35796
Submission : 2021-04-20
Status : Active
Type : II
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-07-09
Pay. Date : 2021-05-25
DMF Number : 35558
Submission : 2021-02-01
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 : 54893-0108
Start Marketing Date : 2021-01-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35757
Submission : 2021-03-29
Status : Active
Type : II
NDC Package Code : 54893-0108
Start Marketing Date : 2021-01-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-06-25
Pay. Date : 2024-06-07
DMF Number : 39468
Submission : 2024-03-28
Status : Active
Type : II
NDC Package Code : 54893-0108
Start Marketing Date : 2021-01-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-10-13
Pay. Date : 2021-09-20
DMF Number : 36263
Submission : 2021-09-15
Status : Active
Type : II
NDC Package Code : 63850-8113
Start Marketing Date : 2023-11-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-06-03
Pay. Date : 2021-04-16
DMF Number : 35762
Submission : 2021-05-03
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-10-30
Pay. Date : 2023-09-22
DMF Number : 38325
Submission : 2023-07-14
Status : Active
Type : II
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