Biocon's Malaysian facility receives 3 observations from USFDA

On Saturday, Biocon announced that it had received 3 observations from the U.S. Food and Drug Administration (USFDA) following an inspection at its insulin manufacturing facility in Malaysia. 

The US regulator had conducted a pre-approval inspection of Biocon's subsidiary, Biocon Sdn. Bhd's manufacturing facility in Malaysia between February 10, 2020, and February 21, 2020. At the conclusion of the inspection, the agency issued a Form 483 with three observations which the company believe are procedural in nature and do not in any way impact the commercialization plans of insulin glargine in the US. 

Form 483 is issued to the firm’s management at the completion of the inspection when inspectors have perceived any conditions that in their judgement which may constitute a violation of the Food Drug and Cosmetic Act and related acts. 

Biocon Limited is a biopharmaceutical company focused on reducing therapy costs of chronic diseases like autoimmune, diabetes, and cancer. The company has a pipeline of Biosimilars and Novel Biologics at various stages of development, including Insulin Tregopil, an oral insulin analog.

At 9:45 am on Monday, the stock was trading at Rs 314.65, down by 0.11 per cent or Rs 0.35 per share. The 52-week high is recorded at Rs 320.48 and the 52-week low is Rs 211.30 on BSE.