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 Sjar Technology Development
07 2Cipla
08 1Hangzhou Longshine Bio-Tech
09 1Hetero Drugs
10 3MSN Laboratories
11 1Natco Pharma
12 1Zhejiang Tianyu Pharmaceutical Co., Ltd
01 4China
02 1Hungary
03 10India
01 8Active
02 7Blank
01 15Blank
01 15Blank
01 1WC-0349
02 14Blank
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 : 2021-10-13
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 : 2021-06-03
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
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 : 2021-08-30
Pay. Date : 2021-06-18
DMF Number : 36029
Submission : 2021-06-30
Status : Active
Type : II
A Acalabrutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acalabrutinib, including repackagers and relabelers. The FDA regulates Acalabrutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acalabrutinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Acalabrutinib supplier is an individual or a company that provides Acalabrutinib active pharmaceutical ingredient (API) or Acalabrutinib finished formulations upon request. The Acalabrutinib suppliers may include Acalabrutinib API manufacturers, exporters, distributors and traders.
click here to find a list of Acalabrutinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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