Recently, Wanbang Biopharmaceuticals has received on-site inspection report from the U.S. Food and Drug Administration (hereafter referred to as "US FDA") for the oral solid dosage form production line compliance with cGMP standards.
The scope of this inspection is the oral solid dosage form production line (workshop V) of Wanbang Biopharmaceuticals. The product involved in this inspection was Montelukast Sodium Tablets. The capacity of this workshop is designed to be 2 billion tablets per annum.
Monelukast sodium tablets are mainly used for the treatment of asthma and allergic rhinitis. This on-site inspection indicates that the manufacturing workshop V of Wanbang Biopharmaceuticals meets the cGMP standard of the US FDA, and the product Monelukast sodium tablets can be commercially produced.