Biocon on Monday, On July 31, 2017, said that this USFDA visit was a part of the regular periodic audit for small molecule injectable.
The company has responded to the regulator with a corrective and preventive action plan and is on track to implement them in timely manner, the company spokesperson said in response to media queries regarding the USFDA visit to Biocon in the month of May/June 2017.
Lupin and Dr Reddy’s Laboratories hits their respective fresh 52-week lows after they reported a weak set of numbers in April-June (Q1FY17) quarter. Sun Pharmaceutical Industries, too, hit 52-week low of Rs 493 on NSE in intra-day trade.
Lupin has lowered its FY18 Ebitda (Earnings before interest, taxation, depreciation and amortization) margin guidance by 500bps owing to higher-than-expected erosion in Glumetza and price pressures in the US base business.
Analysts at IIFL Institutional Equities expect Lupin’s US revenue to decline 20% cc in FY18 due to Glumetza/Fortamet sales erosion. Most of the key near-term launches are expected to begin only in 2HFY18.