Founded in the year of 2015, Hainan Sha Ting Ning Pharmaceutical Co., Ltd is a comprehensive enterprise specializing in the manufacturing of solid preparations and APIs (active pharmaceutical ingredients).The company was granted its business license on 5th, August, 2015, with its registration address being: Plot A-21-1, Haikou Comprehensive Bonded Zone, No. 69 South 1st Ring Road, Economic Development Zone, Old Town, Chengmai County, Hainan Province. The company is situated in the Old Town Economic Development Zone of Chengmai County with extremely convenient transportation. The terrain in the economic development zone is flat and level, providing an open view, and with high afforestation rate and absence of pollution sources, the air is clear and refreshing.
With a total investment capital of RMB 90 million, the company commenced the construction of GMP workshop at its registered address in December, 2015. For now, the first stage of construction has been completed and is ready for use. The company covers a total area of 20000m2, with construction area accounting for 7000m2. The workshop is designed and laid out in strict accordance with GMP requirements, and is comprised of bulk material production workshop, warehouse, testing laboratory, communal project and officing area and so on.
The bulk material workshop is in the middle of the plant complex and is of two-tier framework structure, covering a total construction area of 4000 square meters. It is divided into synthesis area, clean area, auxiliary area (providing air conditioning, water making, drying, power supply, freezing and cooling water etc.)Of all the different areas, the clean area covers a rough area of 960 square meters and is further subdivided into four subareas, each subarea is provided with function rooms like changing room, buffer room, clean hallway, crystallization room, dry room, grinding room, material pending room, packaging material pending room, instrument washing room, instrument storage room, clean instrument room and primary packaging material room and so on. The warehouse and hazardous article warehouse are in the southern part of the plant complex and they are of framework structure. The warehouse covers a total construction area of about 250 square meters and is divided into finished product storage, cold storage, cool storage and packaging material storage and so on. The chemical warehouse covers a total construction area of about 810 square meters and is used for raw material storage. The testing laboratory and administration offices are in the northwest part of the plant complex. The testing laboratory covers an area of 236 square meters and is provided with high temperature room, physicochemical room, gas phase room, liquid phase room, sample room, stability test room, reagent room and microorganism room and so on, in which microorganism belongs to clean area.
The first stage project is mainly designed to provide for the manufacturing of nine API (active pharmaceutical ingredients) categories (including nizatidine, fluconazole, lansoprazole, foscarnet sodium, fexofenadine hydrochloride, nicergoline, tiopronin, asarone, ramosetron hydrochloride), with a total annual capacity of about 50T/year.