Molecules / Acalabrutinib

Acalabrutinib API manufacturers

CAS 1420477-60-6 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
3
shortage records on file across 3 countries
49
finished-dose makers across 39 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Natco Pharma

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for acalabrutinib, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
15 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Alembic Pharmaceuticals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for acalabrutinib, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
18 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

MSN Laboratories

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 3 active US DMFs for acalabrutinib, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
3 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Cipla

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for acalabrutinib, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Chengda Pharmaceuticals

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for acalabrutinib, filing since 2025. Its 2024 FDA inspection closed as NAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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2 more manufacturers hold filings for acalabrutinib

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

CiplaChengda Pharmaceuticals
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Finished-dose makers (7)

Astrazeneca Pharmaceuticals Lp United States Astrazeneca Ab Sweden AstraZeneca UK United Kingdom Ampac Fine Chemicals United States Ajinomoto Belgium Boston Oncology Arabia Saudi Arabia Laboratorio Eczane Pharma Argentina

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

Who makes acalabrutinib?

Ask Fred which manufacturers are on record for acalabrutinib and what filings they hold.

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Also on this molecule

Shortages 3 Finished dose 7 Contract mfrs 0