Small Molecule APIs CDMO Services

Small Molecule APIs CDMO Services

The development and manufacturing of small molecule active pharmaceutical ingredients (APIs) are crucial steps towards getting effective, high-quality therapies to market. And its successful development and production depends on speed, efficiency, and quality. At our company, our small molecule APIs CDMO service aims to bridge the gap between drug discovery and market-ready products. We can offer essential services throughout the entire project lifecycle, from early process optimization and scale-up to commercial production, to ensure your project successfully reaches the market quickly and efficiently by leveraging state-of-the-art technology and rigorous adherence to industry standards.

Our Services and Solutions

We provide end-to-end services that cover the entire lifecycle of drug development and manufacturing. Our comprehensive service offerings include:

APIs Process Development

  • Route design and screening
  • Process development and optimization
  • Process safety assessment
  • Process validation
  • Analytical method development, optimization, and quality control

Scale-up and Technology Transfers

  • Pilot scale (kilogram scale) and glass reactors production
  • Technology transfer
  • Analytical method transfer and validation
  • Transfer or validation of methods for starting materials to APIs
  • EHS assessment

APIs Drug Manufacturing

  • APIs production for toxicity batch to early clinical batch
  • cGMP production of registration starting materials, registration intermediates, and APIs
  • APIs production for late-stage clinical batch
  • Intermediate production
  • APIs production for market approval
  • APIs commercialization manufacturing

Regulatory Submission

  • IND compilation and submission
  • NDA compilation and submission
  • ANDA compilation and submission
  • APIs DMF documents preparation

Our Capacities

High-Efficiency Small Molecule API Development Team

Our team is composed of seasoned professionals with extensive experience in API research and development. Their expertise spans organic synthesis, medicinal chemistry, and process engineering.

500+

Scientific research personnel

800+

New Drug Project

20+

Commercialization Project

Various Specifications Pilot-Scale Production Equipment

We have a cGMP kilo lab. In this lab, we have a wide range of reactor sizes ranging from 20L to 500L. Moreover, we set up a pilot plant. In our pilot plant, we have several production lines and a wide range of pilot reactor sizes ranging from 30L to 3000L with the working pressure range from negative pressure to 12.5 Mpa and working temperature of -80 °C-250 °C.

Commercial Production Equipment for Various Demands

We operate a variety of large-scale reactors and production lines, including high-volume batch reactors and continuous flow systems. Our commercial facilities are designed to produce consistently high-quality APIs at scale, adhering to stringent GMP standards that can facilitate a range of reactions, including high-pressure dehydrogenation and cryogenic reactions. Additionally, our flexible production systems allow us to handle a diverse portfolio of small molecule APIs, meeting the unique demands of each project.

Expertise In Numerous Reactions for APIs

We specialize in a wide range of specialized chemical reactions, including (but not limited to) asymmetric synthesis, cross coupling reaction, azide reaction, diazotization reaction, grignard reaction, fluorination reaction, enzyme-catalyzed reaction, lithium reaction, hydrogen reduction reaction, low temperature reaction and high temperature reaction.

Our Advantages

State-of-the-Art Facilities

01

Our cutting-edge facilities are equipped with the latest technology, ensuring high-precision manufacturing and superior quality control. This technological edge allows us to bring innovative therapies to market faster and more reliably.

Customer-Centric Approach

02

By understanding their unique needs and objectives, we tailor our services to deliver bespoke solutions that add real value. Our commitment to customer satisfaction is reflected in our repeat business and long-term partnerships.

Continuous Improvement and Innovation

03

In an industry driven by innovation, we maintain a relentless focus on continuous improvement. We invest in ongoing research and development, ensuring that we stay ahead of the curve in API technology and manufacturing processes.

Please kindly note that our services are for research use only.

Get in Touch

We’re glad to help you with your products and services demands. For any inquiry, question or recommendation, please send an email to or fill out the following form.

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