Stock Codes:
002821.SZ / 6821.HK
Global

HPAPIs

Service Capability
Our Advantages
Functions

Service Capability

Relying on its two major production bases, Asymchem can stably supply high potency active pharmaceutical ingredients (HPAPIs) to global customers. From R&D and analytical laboratories for high potency compounds to GMP Kilo Labs and manufacturing workshops, a fully enclosed production system is adopted throughout. The containment capability of the equipment meets the occupational exposure limit (OEL) requirement of 1 ng/m³, so as to safeguard the safety of operators, the environment and products. Among them, the GMP compliant Kilo Lab and manufacturing workshops passed USFDA inspections in 2014 and 2019 respectively, and obtained site inspection clearance from NMPA in 2021, boasting a sound production quality management system.

Our Advantages

One stop R&D and production service platform and process

Fresh air HVAC system

Advanced facility design and equipment engineering isolation and containment control strategy concept

Sound cleaning procedures and practices

Equipment particulate containment performance validated in accordance with ISPE guidelines

Professional talent team and rigorous staff training system

Functions

Functions Professional talent team and rigorous staff training system OEL Containment Capability
Kilo Lab Production Area
(Grade D)

Area: Equipped with 9 synthetic production lines, as well as supporting purification and lyophilization areas and complete equipment chains.

Batch scale: 10g to 3kg

Reaction Equipment: 2L to 20L glass reactors (-50°C to 150°C)

Purification Scale: DAC150/200/300/450, nanofiltration, 2.5m² to 10m² ultrafiltration

Separation scale: 5L to 20L pressure filter tanks / filter dryers

Lyophilization Scale: 1 m² / 2 m² / 5 m² / 10 m² lyophilizers

Special Processes: wet milling, jet milling

1 ng/m³
Manufacturing Workshop
(Grade D)

Area: Equipped with 4 synthetic production lines, together with supporting purification, lyophilization areas and complete equipment chains

Batch scale: 1kg to 20kg

Reaction Equipment: 300L to 1,000L reactors (-80°C to 120°C)

Purification Scale: DAC150/200/300/450, nanofiltration, 2.5m² to 10m² ultrafiltration

Separation Scale:DN350 to 500 filter dryers, DN350 to 700 pressure filter tanks

Lyophilization Scale: 1 m² / 2 m² / 5 m² / 10 m² lyophilizers

Special Processes: wet milling, jet milling

1 ng/m³
Analysis

Class A negative pressure isolator, negative pressure isolator compatible with microbalances

VBE Testing Capabilities: microbial sterility testing, limit testing

Physicochemical Testing: HPLC, UPLC, GC, Mass, NMR, IR, etc.

2 ng/m³
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July 29, 2026, 19:29
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