Molecules / Dexmedetomidine / China

Dexmedetomidine API manufacturers in China

CAS 113775-47-6 ATC N05CM18 Updated 9 July 2026
13
China-based manufacturers with an active filing of 19 worldwide
Showing 7 of 13 China-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked China-based API manufacturers

01

Jiangsu Hengrui Pharmaceuticals

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

Holds one active US DMF for dexmedetomidine, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.

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

Asymchem Laboratories (Tianjin)

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

Holds one active US DMF for dexmedetomidine, filing since 2012. 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
03
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dexmedetomidine, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 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
05

Guang'An Kingday Pharma And Chem

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

Holds one active US DMF for dexmedetomidine, filing since 2022. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Asymchem Life Science Tianjin

China
Makes the API

Registered with SFDA (Saudi Arabia) for dexmedetomidine. Its 2025 FDA inspection closed as VAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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6 more manufacturers in China hold filings for dexmedetomidine

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

Open the full list with a free account

How this list is built

This page filters the worldwide Dexmedetomidine 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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