Development & Manufacturing-Asymchem Labs.

Overview

From early route exploration to large-scale manufacturing, Asymchem leverages core technologies including continuous flow chemistry, enzyme engineering and high-throughput process development to break barriers in complex molecule synthesis, enabling precise control and efficient scale-up of process parameters. Whether for high-potency APIs, highly challenging intermediates or innovative formulation development, we remain technology-driven at our core. We deliver reliable and flexible solutions for every development stage, empowering medicines to reach the market faster and more steadily.

Service Capabilities

Preclinical Programs

Route Design & Development

Process Development & Optimization

Process Safety Evaluation

Fast-Track Delivery

Pre-Toxicology & Toxicology Batches

IND submission

Clinical Programs

Clinical Material Manufacturing Regulatory Filing Strategy

Analytical Method Development and Validation

Quantitative Risk Assessment (QRA) Studies

Process Performance Qualification (PPQ) Studies

NDA Filing

Commercial Programs

Commercial Manufacturing

Localized Manufacturing

Lifecycle Management & Optimization

Global Compliance Assurance

Raw Material Supply Chain

Manufacturing Capabilities

5,300

Production capacity of over 5,300 Cubic Meter

8,200

Continuous production area of 8,200 sq. m

20,000

Reactor volume ranging from 5 L to 20,000 L

Small Molecule Manufacturing Site

Asymchem Laboratories (Tianjin) Co., Ltd.

Main Business:

Research and Development of High-Activity Drugs

Asymchem Life Science (Tianjin) Co., Ltd.

Main Business:

Research Services Formulation Services (Oral Solid Dosage, Injectable)

Tianjin Asymchem Pharmaceuticals Co., Ltd.

Main Business:

MAH related innovative drug API Research and production of active pharmaceutical ingredients

Jilin Asymchem Laboratories Co., Ltd.

Main Business:

API production

Jilin Asymchem Pharmaceuticals Co., Ltd.

Main Business:

Production of imipenem raw materials

Asymchem Laboratories (Jilin) Co., Ltd.

Main Business:

API production

Liaoning Asymchem Laboratories Co., Ltd.

Main Business:

API production

Asymchem UK Sandwich

Main Business:

R&D Lab Production of standard active pharmaceutical ingredients

International Quality Management System

Rooted in a sound quality management system, Asymchem has built a compliance assurance system aligned with international standards. Our business spans global markets including China, the United States, the European Union, Japan, South Korea, Canada and Australia. The Company’s manufacturing systems and quality management processes have repeatedly passed rigorous inspections conducted by official pharmaceutical regulatory authorities from various countries, fully complying with international pharmaceutical manufacturing specifications.

Data as of the end of 2024

20+

20+ approved APIs & formulations

150+

150+ process validation products (APIs & formulations)

90+

90+ successful global regulatory inspections

4 FDA PAI exemptions

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