DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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01 1Dr. Reddy's Laboratories
02 1Egis Pharmaceuticals PLC
03 1Aarti Pharmalabs
04 1Alembic Pharmaceuticals Limited
05 1Beijing Sjar Technology Development
06 2Cipla
07 1Hangzhou Longshine Bio-Tech
08 1Hetero Drugs
09 3MSN Laboratories
10 1Natco Pharma
11 1Zhejiang Tianyu Pharmaceutical Co., Ltd
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01 3China
02 1Hungary
03 10India
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01 8Active
02 6Blank
01 14Blank
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01 14Blank
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01 1WC-0349
02 13Blank
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
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 : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-30
Pay. Date : 2021-06-18
DMF Number : 36029
Submission : 2021-06-30
Status : Active
Type : II
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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We have 11 companies offering Acalabrutinib
Get in contact with the supplier of your choice: