Biocon Limited’s stock witnessed a significant 5% decline on October 18 due to the US health regulator’s ‘Official Action Indicated’ (OAI) classification of Biocon Sdn Bhd’s insulin manufacturing facility in Malaysia. This classification raises concerns about potential delays and withholding of product supplements awaiting approval. Biocon informed the Indian stock markets about this development on the morning of October 18, causing its shares to open at Rs 251.95 on BSE and subsequently plummet to Rs 241.60, down from the previous day’s closing price of Rs 254.35.
Biocon’s OAI Designation and Steps Towards Resolution
Similarly, on the NSE, the stock opened at Rs 251.50 and fell to Rs 242, marking a more than 5% decline. The 52-week low for the company’s stock on NSE and BSE was recorded at Rs 191.55 and Rs 191.60, respectively, on March 21, 2023. In contrast, the 52-week high was Rs 295 on NSE and Rs 293.30 on BSE, observed on November 21, 2022.
Biocon Stocks Open Lower After FDA’s Malaysia Plant Inspection Classification
Biocon Limited disclosed that the US Food and Drug Administration (FDA) inspected Biocon Sdn Bhd’s insulin manufacturing facility in Johor, Malaysia, in July of the same year. The FDA’s inspection results led to the facility receiving an ‘Official Action Indicated’ classification.
The company responded by submitting a Comprehensive Corrective and Preventive Action (CAPA) Plan to the FDA in response to the observations made during the July inspection. Biocon remains confident in its ability to complete all necessary actions as committed and continues to collaborate closely with the FDA to address any concerns promptly. Biocon emphasized that it anticipates no significant impact on the company’s commercial product manufacturing and distribution for the US market.