
Comprehensive Pharmaceutical Group

The 6th CMC-China Expo
August 15-16Suzhou International Expo Center

Lunan Pharmaceutical Group is a comprehensiveA comprehensive pharmaceutical group integrating the production, research, and sales of traditional Chinese medicine, chemical drugs, and biologics。There are currently 3 product research and development centers and a 1,400-person R&D team, including 40 doctors and 800 masters. It also has 3 cGMP production bases equipped with top domestic and international brands such as GLATT, IMA, GEA, BOSCH, Truking, and Tofflon. The production equipment boasts a high degree of automation. The core production management team has over 15 years of experience in production and quality management, ensuring the quality of both R&D and manufactured products. The production facilities have been approved.U.S. FDA,EU GMP, Japan PMDA、BrazilANVISA, Mexican COFEPRIS,Certification by the Indonesian Ministry of Health, etc., which can simultaneously meet the registration requirements of many countries around the world. With a wide variety of raw materials and a rich pipeline of formulations, there are 141 raw materials registered on domestic platforms, over 100 raw material projects currently under development and application, and 42 formulation production lines that have passed GMP inspections.
Shandong New Era Pharmaceutical Co., Ltd. Located in Feixian, Linyi City, Shandong Province, the factory is only a 20-minute drive from the high-speed railway station -- Feixian Station. With convenient transportation and a superior geographical location, the raw material production site has already passed...United States, Europe, Japan, Brazil, South KoreaGMP inspections in multiple countries, supporting multi-country applications.
Lunan Better Pharmaceutical Co., Ltd. Tancheng Branch Located in the Economic Development Zone of Tancheng County, Linyi City, Shandong Province, the factory is only 1.5 hours' drive from Xuzhou Station, a stop on the Beijing-Shanghai high-speed railway. With convenient transportation and a superior geographical location, it supports multi-country registration.
Special reactions such as cryogenic, high-temperature, hydrogenation, hydriding, borane, chlorination, oxidation, nitration, and Grignard reaction.
Biocatalysis, Enzyme Catalysis, Microbial Fermentation.
Synthesis of macromolecular drugs, cell fermentation, monoclonal antibodies, bispecific antibodies, etc.
Process and Analytical Method Development
Clinical Sample Development
Pilot and Process Validation
Quality Research
Registration Declaration (China and Foreign)
Commercial Production and Supply
Shandong New Era Pharmaceutical Co., Ltd.Is a company that passedU.S. cGMP and EU GMPThe inspected factory, located in Feixian County, Shandong Province, in eastern China, is only a 20-minute drive from Feixian High-Speed Railway Station. The factory covers an area of 6 million square meters and employs 4,000 people, mainly engaged in the development and production of raw materials and formulations for chemical drugs and biological products.

Ordinary Oral Solid Dosage Production Line
Tablets (conventional tablets, bilayer tablets, shaped tablets, pellet compression tablets), capsules, granules, drop pills, soft capsules, etc.
General Injectable Production Line
Lyophilized powder for injection (non-terminally sterilized injectable, terminally sterilized injectable), terminally sterilized small volume injectable (BFS), pre-filled injectable (pre-filled syringe)
Anti-tumor Injection Production Line
Lyophilized powder for injection, Non-terminal sterilized injections (vial), and Terminal sterilized injections (vial)
Biological Products Formulation Production Line
Lyophilized powder for injection, Non-terminal sterilized injection, Prefilled injection (Prefilled syringe), Cartridge insulin injection (Cartridge)
New Formulation Production Line
Injectable Microsphere Powder, Long-Acting Nanocrystal Suspension Injection, Nano-Liposome Injection, Nano-Liposome Sterile Freeze-Dried Powder Injection
Among them, the three production lines of injectables, tablets, and inhalants in the FDA formulation workshop have passed the U.S. FDA on-site inspection and EU GMP inspection, and can undertake CMO business for domestic and foreign formulation companies.
Formulation Prescription Process Development and Optimization
MAH Product Contract Manufacturing
Small-batch Clinical Sample Production (Clinical Phases I-III)
Registration in Domestic and International Regulatory Markets
Technology Transfer (License-In/Out)
Lunan Better Pharmaceutical Co., Ltd.Located in Linyi City, Shandong Province, the factory is only a 35-minute drive from Linyi High-Speed Railway Station. The factory covers an area of 140,000 square meters and employs 634 people. The company produces chemical active pharmaceutical ingredients, tablets (antibiotic tablets, extended-release tablets), granules, large and small volume injections, powders, eye drops, syrups, oral solutions, sprays, aerosols, plasters, liniments, inhalants, etc. The company has successfully passed more than 40 GMP compliance inspections and 8 inspections by international authoritative organizations (such as the Philippines, Indonesia, Belarus, etc.).Supports multi-country applications in China, the US, and Europe.

General Injection Production Line
Sterile Powder for Injection (Penicillins), Large Volume Parenterals (Terminal Sterilization), Small Volume Parenterals (Terminal Sterilization)
Ordinary Oral Solid Dosage Production Line
Tablets (containing Class II psychotropic drugs, regular tablets, irregular tablets, penicillin class), Capsules
Liquid Preparation Production Line
Inhalants, syrups, oral solutions, aerosols (containing hormones), ointments, liniments, sprays, eye drops, etc.
Liquid Preparation Production Line (BFS)
Inhaled Suspensions (Hormonal), Eye Drops, Inhaled Solutions, etc.
Formulation Prescription Process Development and Optimization
MAH Product Contract Manufacturing
Small-batch Clinical Sample Production (Clinical Phases I-III)
Registration in Domestic and International Regulatory Markets
Technology Transfer (License-In/Out)

Lunan Pharmaceutical Group Corporation Research and Development Center
Can undertake active pharmaceutical ingredients and complex high-end formulations, such as inhalations, semi-solid formulations, microsphere powder injections, and nano-liposome injections.Injection、CDMO services for formulations such as sustained-release, controlled-release, and freeze-dried powder injections in China and overseas, including U.S. ANDA development and submission services.
Number of Laboratories: 30+
Area: 20,000㎡+
Number of R&D personnel: 1400+
Formulation Prescription Process Development and Optimization
Small-scale Clinical Sample Production (Clinical Phases I-III)
Registration in Domestic and International Regulatory Markets
Technology Transfer of Biological Products (License-In/Out)

Li Yan Feng: 15106672372
Email: cdmo@lunan.cn

About CMC-China Expo
About CMC-China Expo
