Hainan Poly Pharm’s Manufacturing Units Get GMP Nod From Saudi Food and Drug Authority

Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, announced that it has received a GMP certificate from the Saudi Food and Drug Authority (SFDA). The GMP certification covers seven pharmaceutical varieties registered in Saudi Arabia, including eptifibatide, nitroprusside, folinic acid, ganciclovir, azithromycin, cyclophosphamide, and levetiracetam. A total of five workshops, named Injection 1, Injection 2, Injection 3, Injection 4, and Injection 9, have passed the GMP inspection.

Notably, Injection 9, which belongs to a newly constructed facility of Hainan Poly, marks the company’s first fully independent terminal sterilization production line. This line covers a range of 2-100ml penicillin bottle specifications and has an annual production capacity of 30 million units. It has not only passed domestic GMP inspections and Saudi official inspections but has also been filed for regulatory changes in the European Union and the United States.

Saudi Arabia relies heavily on drug imports, and the increasing incidence of chronic diseases has exerted pressure on the healthcare budget. Despite various government initiatives to encourage localization, the pharmaceutical industry in the Middle East has struggled to meet the growing demand for pharmaceuticals.- Flcube.com

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