Molecules / Ibrutinib / China

Ibrutinib API manufacturers in China

CAS 936563-96-1 ATC L01XE27 Updated 9 July 2026
12
China-based manufacturers with an active filing of 16 worldwide
$5936.92
median export price per kg, all origins $4347.20 to $6443.29 · 8 exporters · 2025
Showing 6 of 12 China-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked China-based API manufacturers

01

Sichuan Kelun Pharmaceutical

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

Holds one active US DMF for ibrutinib, filing since 2025. Its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Wisdom Pharmaceutical

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

Holds 3 active US DMFs for ibrutinib, filing since 2017. Its 2024 FDA inspection closed as NAI.

US DMF
3 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
View profile
03

Esteve Huayi Pharmaceutical

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

Holds one active US DMF for ibrutinib, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

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

Zhejiang Huayi Pharmaceutical

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

Holds one active US DMF for ibrutinib, filing since 2024. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Beijing Hope Pharmaceutical

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

Holds one active US DMF for ibrutinib, filing since 2022.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Zhejiang Langhua Pharmaceutical

China
Makes the API

Registered with SFDA (Saudi Arabia) for ibrutinib. Its 2024 FDA inspection closed as VAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

6 more manufacturers in China hold filings for ibrutinib

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Sichuan Kelun PharmaceuticalWisdom PharmaceuticalEsteve Huayi PharmaceuticalZhejiang Huayi PharmaceuticalBeijing Hope PharmaceuticalZhejiang Langhua Pharmaceutical
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How this list is built

This page filters the worldwide Ibrutinib manufacturer list to companies based in China. 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. Read the full method.

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All Ibrutinib manufacturers

Worldwide 16 India 13