Gansu Purest Pharmaceutical Co., Ltd. was established in 2020 and is located in the Biomedical Intermediate Industry Incubation Park of Baiyin City, Gansu Province. The company focuses on the process development and production technology improvement of pharmaceutical intermediates, and small molecule chemical raw materials. Enterprises and research institutes provide CDMO/CMO services.
Company achievements:
In June 2021, the first commercial species of tofacitinib key intermediate ((3R,4R)-N,4-dimethyl-1-(phenylmethyl)-3-piperidinamine hydrochloride was successfully completed The commercial supply of salt, CAS: 1062580-52-2).
Development model:
The company focuses on the commercial supply of commercial small molecule chemicals.
Services and solutions:
Development and commercial production and supply of chemicals. High-quality, high-competitive chemical supply. As a newly-started CDMO company, Presi is committed to developing APIs and intermediates for customers with an experienced process research and development team. "Fit for purpose" is the basic requirement of process research and development, based on the balance of efficiency, cost and risk in the chemical development stage.
Route design and development
Assess whether the existing route and related steps meet the requirements of scale-up, cost, safety, and quality control
 A chemist with rich experience can suggest new synthetic routes and conduct laboratory explorations of new routes
 Through parallel reaction equipment and high-throughput screening platform to quickly open up and optimize key steps
 Applying new technology to turn unacceptable steps into acceptable
Process development and optimization
Fit for purpose process development and control strategy formulation
Final process development suitable for commercial production and supply
Process optimization to obtain a robust process, reduce costs and increase output
 Process safety testing and evaluation
Equipment risk assessment for project transfer (such as the choice of kettle and paddle type)
Process verification process
Process verification documents: process report, method verification report, batch production record master, process verification plan
Process verification batches generally include 1 to 2 pre-verification batches and 3 process verification batches
 For the process verification batch, at least one batch of stability tests will be done; if the process verification batch has not been done, then all 3 batches of process verification batches will be tested for stability
Finally form a process verification report
Process safety assessment
 Quickly and accurately measure the reaction heat, exothermic rate, heat accumulation, reaction outgassing rate, total outgassing, etc. in the reaction process
Measure the initial decomposition temperature of the sample, the amount of heat released, and the temperature and pressure changes during the decomposition of the sample. Evaluate the thermal stability of the sample
Assess the hazard level of the process
 Based on the scale of reaction and equipment parameters, evaluate the feeding rate of process amplification, etc.

Safety control of production operations
From the initial stage of production design, establish a sound management system, identify and control safety risks, improve production efficiency and safety, and ensure the safety of production operations.
 The company adheres to the concept of "safety comes from design", adopts HAZOP/LOPA risk methods in the design stage to fully identify and control safety risks, and adopts scientific control methods to improve intrinsic safety
The company has established a full life cycle management system for equipment and facilities, using engineering control methods such as closed control equipment and facilities and a complete inerting and explosion venting system to meet the needs of the production process while improving production efficiency and safety
The company has formulated complete safety production regulations and operating procedures, including process safety, occupational health and environmental protection risk identification, assessment, testing and control procedures to ensure the safety of production operations and ensure the sustainable development of personnel health and the environment
The company selects suitable employees and provides sufficient skill training and safety training to ensure safe production operations


R & D Center:
Under formation
Production base construction:
In August 2020, the construction of the Inner Mongolia production base was completed and successfully put into operation. The equipment is a multifunctional reactor, covering conventional equipment from 500L to 5000L and ultra-low temperature equipment of -100 degrees.
Product display:
Tofacitinib intermediate, CAS: 1062580-52-2