Biocon slips after USFDA issues 10 observations

Biocon fell 5.21% to Rs 355.75 at 12:45 IST on BSE after the US drug regulator issued 10 observations on the drugmaker's Bangalore plant.

Meanwhile, the S&P BSE Sensex was down 63.21 points, or 0.20% to 32,174.67.

On the BSE, 7.88 lakh shares were traded in the counter so far, compared with average daily volumes of 3.34 lakh shares in the past one quarter. The stock had hit a high of Rs 359.05 and a low of Rs 341 so far during the day. The stock hit a record high of Rs 424.15 on 19 July 2017. The stock hit a 52-week low of Rs 255.41 on 12 August 2016.

The stock had outperformed the market over the past one month till 3 August 2017, rising 10.59% compared with 3.18% rise in the Sensex. The scrip had also outperformed the market in past one quarter, rising 8.52% as against Sensex's 7.97% rise. The scrip had also outperformed the market in past one year, rising 36.43% as against Sensex's 16.32% rise.

The large-cap company has equity capital of Rs 300 crore. Face value per share is Rs 5.

The US Food and Drug Administration (USFDA) issued a Form 483 a form listing violations after an inspection between 25 May 2017 and 3 June 2017.? The FDA issues a Form 483 if its investigators spot any conditions that in their judgement may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related laws.

USFDA observed inadequate procedures by the company to prevent microbiological containment of drug products, unexplained discrepancy in batches of the same product, no complete records of data derived from all tests to assure compliance with standards, lack of authority and responsibility of the quality control unit to accept or recent drug, among others.

USFDA said that the employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.

Besides, the lab controls do not include the establishment of scientifically sound and appropriate specifications and test procedures, USFDA said.

On a consolidated basis, net profit of Biocon declined 51.20% to Rs 81.30 crore on 5.60% decline in net sales to Rs 927.40 crore in Q1 June 2017 over Q1 June 2016.

Biocon is India's largest and fully-integrated, innovation-led biopharmaceutical company.

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