Biocon announced on 24 January 2020, that the US Food and Drug Administration (USFDA) conducted a pre-approval inspection (PAI) and Good Manufacturing Practice (GMP) inspection of the Active Pharmaceutical Ingredient (API) manufacturing facility of Biocon.
At the conclusion of the inspection of the Bengaluru facility, which took place between 20 and 24 January 2020, the agency issued a Form 483, with five observations. The firm did not provide details of the observations.
According to media reports, the five observations include, the cleaning validation protocols are not adequately performed; the company failed to adequately investigate non-conformances; equipment used in production operations are not adequately qualified; the company failed to fulfill responsibilities of the quality control unit; and the company failed to adequately handle, store & document material movement & status.
In the past one month, the scrip advanced 3.36%. On the technical front, the stock’s RSI (relative strength index) stood at 53.439. The RSI oscillates between zero and 100. Traditionally the RSI is considered overbought when above 70 and oversold when below 30.
The stock was currently trading between its 10-day moving average (DMA) placed at Rs 307.11 and its 20-DMA placed at Rs 302.24.
On a consolidated basis, net profit fell 6.6% to Rs 202.80 crore in Q3 December 2019 (Q3 FY20) from Rs 217.20 crore in Q3 December 2018 (Q3 FY19), due to higher R&D expenses and tax impact of an exceptional item. Profit before tax (PBT) stood at Rs 315.10 in Q3 FY20, up by 8.9% from Rs 289.30 crore in Q3 FY19.
Biocon is an innovation-led global bio-pharmaceuticals company.