Company Profile

Zhejiang Kisun Pharmaceutical Co., Ltd., based in Zhejiang and serving the global market, is a modern pharmaceutical enterprise dedicated to the R&D and production of high-quality drug products. The company's production facilities have obtained both Chinese and European GMP certifications, achieving full alignment with international standards through a stringent quality system and standardized management. Kisun has established a deep collaboration with the renowned German pharmaceutical company STADA to jointly produce a variety of high-end drug products, creating synergistic advantages in quality control, technical processes, and market expansion. Building on the quality foundation of dual China-Europe GMP certification and the in-depth partnership with STADA for producing high-quality drug products, Kisun adheres to international standards, drives innovation in R&D, and advances a diverse product pipeline. It is committed to providing safer, more reliable, and trustworthy pharmaceutical solutions for patients worldwide.

 

Upholding the philosophy of “Quality as the Foundation, Innovation as the Driving Force, and Patients First,” the company continues to increase its investment in R&D and build a robust pipeline of drug candidates with strong market potential and clinical value, covering a wide range of therapeutic areas. Kisun is committed to consistently providing healthcare institutions and patients with safer, more effective and more stable drug product options, striving to become a trustworthy international pharmaceutical partner.

 

 

Launched drug products:

Sitafloxacin Tablets

Imatinib Mesylate Tablets

Company Construction Plan

The plant construction will be completed in two phases. Phase I involves the construction of two buildings and related auxiliary facilities for solid dosage form, one of which is an OEB3/OEB4 containment oral targeted drug products building. Phase II will include the construction of solid dosage form facilities, R&D building, quality control building, injection products building, digital warehouse and so on.

Factory building

Construction Progress

2019, Kisun signed an investment cooperation agreement with the Taizhou Bay Circular Economy Industrial Cluster Management Committee to establish a new high-end drug products base. implemented in two phases. On January 19, 2020, Kisun executed the "Grant Contract for State-Owned Construction Land Use Rights" and the "Standard Land Investment and Construction Contract for Industrial Enterprise Projects." The construction permit for the Phase I project was obtained on July 31, 2020, with physical construction commencing accordingly. Pile driving for the foundation began in August 2020.

 

All projects under Phase I have been completed as planned, including two production plants, one auxiliary production building, environmental protection treatment facilities, a reagent warehouse, and corresponding supporting facilities. The total construction area is approximately 41,000 square meters.

 

The utility systems - including steam system, chilled water system, compressed air system, tap water, and purified water - are all currently in normal operation.

Air conditioning unit

Air conditioning unit

Refrigeration unit

Refrigeration unit

Purified Water Preparation System and Distribution System

Purified Water Preparation System and Distribution System

QC: laboratories have been fully established with completed equipment procurement, installation, equipment qualification and validation, and HVAC system validation. The QC management system is now in place, meeting all requirements for normal operation.

Cleaning Room

Cleaning Room

Liquid-phase chamber

Liquid-phase chamber

Clean corridor

Clean corridor

Leaching Chamber

Leaching Chamber

Production: The production workshops in both plants have been fully constructed, with equipment installation, commissioning, and qualification completed. The production system has been established and meets all requirements for normal operation. Plant 1 utilizes a fully enclosed production line with integrated online cleaning and drying systems. The unified operational design achieves the highest degree of automation and control currently possible in the pharmaceutical industry. The production equipment features industry-leading technology, with key machinery including granulation equipment, capsule filling machines, and packaging systems imported directly from Germany, laying a solid foundation for ensuring product quality.

 

Building upon this foundation, advanced technologies and equipment such as hot melt extrusion, laser drilling,  spray granulation and so on will be introduced according to product demands. These additions will cover a broader spectrum of pharmaceutical manufacturing technologies, diversify the product portfolio, and enhance the company's overall technical capabilities.

Granulation Line Equipment

Granulation Line Equipment

Tablet press

Tablet press

Coating machine

Coating machine

System Integration Control Center

System Integration Control Center

Development History

February, 2022

Inspection Agency: Provincial NMPA Dosage Form: Tablets Result: Obtained Production License

January, 2023

Inspection Agency: Provincial NMPA Dosage Form: Tablets Result: Passed Tablets Compliance Inspection

February, 2023

Inspection Agency: Provincial NMPA Dosage Form: Tablets Result: Production License Amended to Include Certificate C

April , 2023

Inspection Agency: Europe EU Dosage Forms: Tablets and Capsules Result: Passed GMP Certification

May, 2024

Inspection Agency: Provincial NMPA Dosage Form: Tablets Result: Passed Unannounced Inspection

September, 2024

Inspection Agency: Europe EU Dosage Forms: Tablets and Capsules Result: Passed GMP Certification

Product Planning & Progress

Kisun Pharmaceutical is dedicated to research and development, production, and sales of injections and oral solid dosage forms drug products. We also provide custom processing for clients, along with import and export of pharmaceuticals and technologies, demonstrating very promising development prospects.

 

To date, we have completed the R&D of more than 10 drug products, including tablets, capsules and injections. In 2022, we plan to scale up 12 drug products, complete validation for 6–8 products, and finalize bioequivalence (BE) studies for 1–2 products.


In 2022, we will also initiate R&D for an additional 6–8 new products. In subsequent years, a similar number of new R&D projects will be added annually, which will significantly enhance our production capacity and better meet market demand.

 

The company is actively expanding multi-channel operations to accelerate the comprehensive development of our drug products business. In addition to proprietary R&D, we are focusing on CDMO, CRO, and co-development services. We are currently in successful negotiations with several internationally renowned companies regarding these collaborations.

Five-Year Plan

While meeting the R&D and production needs of its own portfolio, the company is also able to provide integrated “pilot-to-commercial” CMC/CMO services covering multiple dosage forms, strengths and batch sizes, offering a one-stop solution that helps partners efficiently advance products from development to commercialization. By building a well-balanced portfolio of generic and innovative drug products and strategically expanding into highly regulated markets such as China, the United States and Europe, as well as developing and emerging markets, Kisun aims to establish a truly global sales footprint and further strengthen its competitiveness in the international pharmaceutical sector, emerging as a strong contender within the industry.

Corporate Culture

Core values: Respect, Integrity, Collaboration, Mutual Success

Mission: Serving Health, Creating Future Together
Vision: We are committed to becoming a distinctive pharmaceutical enterprise with global competitiveness.
Corporate Culture: Unity, Diligence, Pragmatism, Innovation; Conducting Ourselves with Integrity, Contributing to the Society.
Core Values: Respect, Integrity, Cooperation, Win-Win.

Corporate Responsibility

Qizheng Pharmaceutical

Kisun focuses on producing conscientious, reliable, and effective drugs!
We are a specialized enterprise; Kisun is an envoy of health, serving consumer wellness.
Conscience:Kisun comes first.
Expertise: Becoming specialists in medicine.

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