Lunan Pharmaceutical Group Submits IPO Prospectus: A Comprehensive Pharma Player in TCM, Chemical Drugs, and Biologics Confirmed for 8th CMC-China Expo
Lunan Pharmaceutical
Comprehensive Pharmaceutical Group
Lunan Pharmaceutical Group Corporation is a comprehensive pharmaceutical group integrating the production, research and development, and sales of traditional Chinese medicines, chemical drugs, and biological products. Its member enterprises include Lunan Houpu Pharmaceutical Co., Ltd., Lunan Better Pharmaceutical Co., Ltd., Shandong New Era Pharmaceutical Co., Ltd., and the Tancheng Branch of Lunan Better Pharmaceutical Co., Ltd., among others.
1. Shandong New Era Pharmaceutical Co., Ltd. is located in Fei County, Linyi City, Shandong Province. The factory is only a 20-minute drive from Feixian High-Speed Railway Station, offering convenient transportation and a superior geographical location, with capabilities to support regulatory filings in China, the United States, and Europe.
2. The Tancheng Branch of Lunan Better Pharmaceutical Co., Ltd. is located in the Economic Development Zone of Tancheng County, Linyi City, Shandong Province. The factory is only a 1.5-hour drive from Xuzhou Station on the Beijing-Shanghai High-Speed Railway, offering convenient transportation and a superior geographical location, and supports regulatory filings in China, the United States, and Europe.
Capable of undertaking CMO/CDMO services for the following chemical reactions and active pharmaceutical ingredients (APIs):
Formulation Production Base I
Shandong New Era Pharmaceutical Co., Ltd. is a national key high-tech enterprise integrating production and scientific research. Established in 2002, it was invested and constructed by Lunan Pharmaceutical Group Corporation. The company is primarily engaged in the research, development, and production of traditional Chinese medicines, chemical active pharmaceutical ingredients (APIs), pharmaceutical preparations, biopharmaceuticals, and genetic engineering products. It has successfully passed 77 domestic GMP inspections, five on-site inspections by the US FDA, and two on-site inspections by the German authorities in Tübingen (for preparations). Additionally, it has repeatedly passed official GMP inspections conducted by countries such as Japan, South Korea, Mexico, and Brazil. The company operates 27 production workshops, covering production lines for granules (including cephalosporins and anti-tumor agents), tablets (including anti-tumor agents), powder injections (cephalosporins), lyophilized powder injections (including anti-tumor agents), hard capsules (including anti-tumor agents), small-volume injections (including anti-tumor agents), suppositories, dripping pills, soft capsules, capsule powder aerosols, dry suspensions, inhalation solutions, oral solutions, therapeutic biological products, APIs, and sterile APIs.
Available Formulation Production Lines:
1. General Oral Solid Dosage Form Production Line
Tablets (conventional tablets, bilayer tablets, shaped tablets, pellet-compressed tablets), capsules, granules, dripping pills, soft capsules, etc.
2. General Injection Production Line
Lyophilized powder for injection (non-terminally sterilized injectables, terminally sterilized injectables), terminally sterilized small-volume injectables (BFS), pre-filled syringes (pre-filled syringes).
3. Antineoplastic Injection Production Line
Lyophilized powder for injection, non-terminally sterilized injections (in vials), and terminally sterilized injections (in vials).
4. Biologic Drug Product Manufacturing Line:
Lyophilized Powder for Injection, Non-terminally Sterilized Injection, Pre-filled Syringe Injection (Pre-filled Syringe), Cartridge Insulin Injection (Cartridge).
5. New Formulation Production Line
Microsphere powder for injection, long-acting nanocrystal suspension for injection, nano-liposome injection, and sterile lyophilized nano-liposome powder for injection. Among them, the injections from the FDA formulation workshop,
Three production lines for tablets and inhalants have passed the on-site inspection by the U.S. FDA, enabling us to undertake CMO services for pharmaceutical formulation companies both domestically and internationally.
6. Traditional Chinese Medicine (TCM) oral liquids (in bottles and composite film strip packs), tablets, granules, pills, capsules, etc.
Preparation Production Base II
Lunan Better Pharmaceutical Co., Ltd. was established in 2003 as a production platform under Lunan Pharmaceutical Group Corporation. For over two decades, it has been providing efficient hospital pharmaceuticals and medical application products to healthcare institutions in China and other countries. The company is located in Linyi City, Shandong Province, in eastern China. Its manufacturing facility covers an area of 140,000 square meters and employs 634 staff members. The company’s product portfolio includes chemical active pharmaceutical ingredients (APIs), tablets (antibiotic tablets, conventional tablets, and sustained-release tablets), capsules, granules, large-volume injections, small-volume injections, powders, eye drops, syrups, oral liquids, sprays, aerosols, plasters, liniments, and inhalants. All production workshops are certified compliant with Good Manufacturing Practice (GMP) standards. The company has successfully undergone more than 40 GMP compliance inspections and eight inspections by international authoritative bodies from countries including Colombia, Nigeria, Kenya, Uganda, the Philippines, Indonesia, and Belarus.
Available Formulation Production Lines:
1. General Injection Production Line
Sterile Aseptic Powder for Injection (Penicillins), Large/Small Volume Injections (Terminal Sterilization).
2. Production Line for Conventional Oral Solid Dosage Forms
Tablets (penicillins, Class II psychotropic substances, conventional tablets, and shaped tablets) and capsules.
3. Liquid Preparation Production Line
Syrups, oral solutions, aerosols (including hormonal preparations), ointments, liniments, sprays, eye drops, etc.
4. Liquid preparation production line (BFS): inhalation suspensions (hormonal), eye drops, inhalation solutions, etc.
