Established in October 2020, Chiheal Pharma Factory is strategically located in the picturesque "Peony Capital" of Shandong, Heze. This state-of-the-art manufacturing facility is a modern and high-end formulation production base developed and constructed by Chiheal Biomed. It stands as a key investment project for Heze City's Lu Xi New District in 2020 and was incorporated into the significant project directory of Shandong Province by the Shandong Provincial Government in January 2023.
With a total investment of 800 million RMB, the Chiheal Pharma Factory project spans an expansive 150 acres, embodying a commitment to industry-leading pharmaceutical production. Featuring over 10 automated production lines designed in compliance with the cGMP standards of the United States, EU GMP, and China GMP, our facility is poised to set new benchmarks in quality assurance.
Our primary focus lies in the production of anti-tumor drug formulations, comprehensive injectables, oral formulations, eye drops, topical patches, and ointments. The annual production capacity reaches an impressive one billion units (bottles) across various formulations. As part of our expansion plan, we envision the construction of 14 active pharmaceutical ingredient workshops. This includes four independent workshops dedicated to antibiotics, anti-tumor drugs, hormones, and peptide-based drugs. This strategic development will robustly support the entire product chain for pharmaceutical intermediates, generic drugs, and innovative medications. Chiheal Pharma Factory is committed to excellence, adhering to the highest industry standards in pharmaceutical manufacturing.
Our comprehensive quality management system covers on-site supervision, environmental monitoring, document management, validation management, calibration management, material management, supplier audits, and warehouse management. These robust processes ensure the highest standards in quality across all aspects of our pharmaceutical operations, from manufacturing to storage.
Quality Control:
Our testing capabilities encompass a thorough examination of incoming materials, in-process inspections, finished product assessments, and final factory inspections, as well as stability studies and the testing of public media. The array of testing equipment at our disposal includes High-Performance Liquid Chromatography (HPLC) systems from renowned brands such as Thermo Fisher, Agilent, and Shimadzu, Gas Chromatography (GC) from Agilent, Liquid Chromatography-Mass Spectrometry (LC-MS) from Thermo Fisher, Gas Chromatography-Mass Spectrometry (GC-MS) from Agilent, Inductively Coupled Plasma Mass Spectrometry (ICP-MS) from PerkinElmer, Atomic Absorption Spectroscopy (AAS) from PerkinElmer, Ion Chromatography (IC) from Thermo Fisher, Ultraviolet (UV) analysis from Shimadzu, Infrared (IR) analysis from Shimadzu, Microbalance from Mettler, and Walk-in Stability Chambers from Espec.
Our commitment to utilizing advanced and diversified testing equipment ensures the precision and accuracy required for the stringent quality standards in the pharmaceutical industry.
Production Line Platform:
Our company boasts the largest industrialized liposome production line for anti-tumor drugs in the country, complemented by the most comprehensive Blow-Fill-Seal (BFS) production lines supporting a diverse range of formulations.
Integrated Ampoule Freeze-Drying/Water Needle Line
Specifications: 1 to 50 ml
Annual Production Capacity: 70 million units
Comprehensive BFS Water Needle/Inhalant Line
Specifications: 1 to 20 ml
Annual Production Capacity: 50 million units
Comprehensive BFS Eye Drop Line
Specifications: 0.35 ml
Annual Production Capacity: 70 million units
Hormone-based BFS Inhalant Line
Specifications: 15 ml
Annual Production Capacity: 30 million units
Anti-tumor Liposome Line (Active Drug Loading)
Specifications: 1 to 10 ml
Annual Production Capacity: 15 million units
Anti-tumor Liposome Line (Passive Drug Loading)
Specifications: 0 to 50 ml
Annual Production Capacity: 5 million units
Anti-tumor BFS Water Needle Line
Specifications: 1 to 20 ml
Annual Production Capacity: 30 million units
Integrated Pre-filled Syringe Line
Specifications: 1 ml
Annual Production Capacity: 30 million units
Integrated Oral Liquid Line
Specifications: 10 ml
Annual Production Capacity: 100 million units
Integrated Large Capacity Syrup Line
Specifications: 50 to 300 ml
Annual Production Capacity: 20 million bottles
These advanced production lines showcase our commitment to precision, efficiency, and delivering a wide array of pharmaceutical solutions to meet the evolving needs of the industry.