Beijing Beilu Pharmaceutical Co., Ltd. (hereinafter referred to as “Beilu”) mainly produces Contrast Media, oral anti-diabetic drugs, and anti-anxiety traditional Chinese medicine, with its production base located in No. 3 Shuiyuan Road, Industrial Development Zone, Miyun District, Beijing and covering an area of 40,000 m2. Building 1 is a comprehensive preparation building with four floors and a building area of 10,745 m2. The Quality Center (QC) located on the second floor of Building 1 is used for physical, chemical, and microbiological inspection. The warehouse located on the first floor of Building 1 is responsible for the storage of raw materials, excipients, and packaging materials. Building 2, workshop 201 (injection workshop), which is located in the north of Building 1, is a two-floor workshop to cover an area of 2000-2500 m2. Building 3, the finished products warehouse, which is located in the north of Building 2, is a one-floor workshop to cover an area of 2000 m2.
Workshop 201 is an independent two-floor building with a building area of 5000 m2 including an 850 m2 clean area. Its main production equipment includes the automatic batching system of Morimatsu, the automatic filling line of Bosch Packaging Technology (Hangzhou) Co., Ltd. FEDEGARI sterilization cabinet, Brevetti light inspection machine, and so on. Such equipment and facilities were built and put in service in 2013. All production equipment has been subject to periodic preventive maintenance and reconfirmation based on relevant documents and has been kept in a good stable state. The workshop of Beilu Pharma is designed and constructed according to the“Good Manufacturing Practice (Rev 2010)” of the State Food and Drug Administration and EU GMP standard.
Workshop 201 is an injection production workshop of big and small capacities with an existing production line. Its main products comprise Gadopentetate dimeglumine injection for enhanced magnetic resonance imaging, Iohexol injection (Shuangbei) for CT enhancement and interventional (including cardiovascular intervention) examination and therapy, Iodixanol injection for angiography, urography, phlebography, and CT enhancement scanning examination, Iopamidol injection for neuroradiology, angiography, urography, enhanced scanning in CT examination, arthrography, epistolography, and digital subtraction angiography, and gadobenate dimeglumine injection (paramagnetic contrast agent) for diagnostic magnetic resonance imaging (MRI) for the liver and central nervous system. All these products are the final sterilized product.