Based on the current situation of domestic pharmaceutical production, Haisco is selecting the light assets operation mode, adopting the production mode of combining own production, cooperative production and outsourcing production to further integrate industry and social resources.
At present, Liaoning Haisco Pharmaceutical Co., Ltd., Sichuan Haisco Pharmaceutical Co., Ltd., Haisco Pharmaceutical (Meishan) Co., Ltd., and Shenyang Haisco Pharmaceutical Co., Ltd., all the four self-owned production bases have selected the linkage production lines of advanced domestic and foreign manufacturers. The main production and inspection equipment are from foreign manufacturers with advanced technology, which realizes the mechanization and automation of production, and can better meet the advanced production process while ensuring product quality and meeting GMP requirements.
Liaoning Haisco Pharmaceutical Co., Ltd. was established on May 19, 2005, with a registered capital of RMB 780 million. In July 2011, it was recognized as a national high-tech enterprise covering an area of about 76,000 m2, and has built more than 50,000 m2 of various workshops and supporting facilities that meet the national GMP standards of China. The company has 8 professional production lines for such as small-volume injections (including pre-filled syringes), lyophilized powder for injection (including hormones), powder for injection (cephalosporins), large-volume injections (including multi-layer co-extrusion infusion bags), drug substances. Among them, the multi-chamber bag infusion production line with international advanced level has been constructed, and Medium and Long Chain Fat Emulsion, Amino Acid (16) and Glucose (16%) Injection has obtained the first (exclusive) approval for the production of multi-chamber bag infusion productions in China, and the product has been marketed at the end of 2018, filling the blank of domestic multi-chamber bag infusion.
The company has always been focusing on the development of new products, the marketed and developed products cover numbers of therapeutic areas such as anti-infection, digestive system, hematological system, nervous system, and parenteral nutrition. As of December 2020, Liaoning Haisco Pharmaceutical Co., Ltd. has obtained 39 drug production approval numbers for 28 varieties, including Compound Vitamin for Injection (3), Medium and Long Chain Fat Emulsion Injection (C8-24), Compound Amino Acid Injection (18AA-VII), Dorasetron Mesylate Injection, Fat Emulsion, Amino Acid (17) and Glucose (11%) Injection, Palonosetron Hydrochloride Injection, as well as five new drug certificates such as Nalmefene Hydrochloride Injection, Dorasetron Mesylate Injection, Compound Vitamin for Injection (3), and Arginine Glutamate Injection.
Sichuan Haisco Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Haisco Pharmaceutical Group Co., Ltd., located in the Cross-Strait Science and Technology Industry Development Park, Wenjiang District, Chengdu, covering an area of 33,266 m2 with a registered capital of RMB 130 million. Sichuan Haisco is oriented as a R&D-driven manufacturing base, which involves process development, intermediate experiment scale-up, production of clinical samples and commercial production of raw materials and auxiliary materials in various fields such as cardiovascular, anti-infection, digestive system, mental system, liver disease and metabolic system.
Sichuan Haisco has a group of professional talents, Dr. Haijun ZHANG, General Manager, and Dr. Haifeng ZHANG, Deputy General Manager and others, have rich experience in drug R&D and production management at home and abroad. There are more than 300 personnel of such as R&D, quality and manufacture in the base, including 38% of R&D personnel, 14% of quality personnel, and bachelor degree or above accounted for 58%.
Sichuan Haisco owns a variety of functional laboratories, including such as synthesis, preparation, analysis, and has dozens of R&D and testing devices and equipment including such as photochemical reactors, nuclear magnetic resonance, XRD, CAD, liquid chromatography, gas chromatography, preparative liquid chromatography, multifunctional granulator. Currently, the projects under development include several innovative drug projects such as HSK7653, HSK16149 and several generic drug projects.
Sichuan Haisco has a sound production management team, and has established a relatively well-organized quality management system, which has passed China GMP inspection for multiple times. Currently, it has several production lines such as tablets, capsules, granules, ointments and drug substances that meet the GMP requirements of China, including the production capacity of 31 tons/year for non-sterile drug substances, production line capacities of 110 million tablets/year for tablets, 110 million capsules/year for capsules and 18 million bags/year for granules.
Sichuan Haisco is constantly improving the level of cGMP management and strives to enter the US market by passing US FDA inspection.
Haisco Pharmaceuticals (Meishan) Co., Ltd. is a wholly owned subsidiary of Haisco Pharmaceutical Group Co., Ltd., established in 2013. It covers an area of 180 mu, and has more than 4,000 m2 of workshops and laboratories that meet GMP standards, it has nearly 400 employees currently and a cumulative investment of 400 million yuan. It is a comprehensive pharmaceutical manufacture enterprise which integrates the scaling commercial production, process development optimization and quality research.
As the commercial production base of non-sterile drug substance and solid formulations of the Group, the company has several production lines for such as tablets, capsules, granules, ointments, creams and drug substances, with more than 30 marketed varieties currently and more than 20 projects under development, which are widely involved in the fields of cardiovascular, anti-infection, digestive system, mental system, liver disease and diabetes mellitus. Since 2016, our company has experienced more than ten registered site inspections and GMP certification inspections for dozens of projects, including: site inspection of drug registration, site inspection of generic drug consistency evaluation, etc.
The company is committed to providing the most up-to-date and high-quality drugs for the majority of patients, actively fulfilling social responsibilities and becoming a first-class pharmaceutical production base that meets cGMP standards, occupational health and safety management system and environmental management system in China.
The company passed the certification as Work Safety Standardization Grade II Enterprise (hazardous chemicals) in 2018 and was listed as a provincial safety culture construction demonstration enterprise in Sichuan Province in 2019.
Shenyang Haisco Pharmaceutical Co., Ltd. was established in February 2015. It is a pharmaceutical production enterprise integrating product R&D and manufacture, the construction area of the site is about 100,000 m2, and the company has more than 200 sets of production, quality and R&D equipment currently. The company has established various production lines and supporting facilities of about 90,000 m2 in line with national GMP standards of China, and established professional production lines such as large-volume injections, multi-chamber soft bags, the total investment of the project is RMB 730 million.