Granules India crashes 13% on USFDA's 6 observations issued to Gagillapur facility

So far this year, shares of Glenmark Life surged over 46 percent

Shares of Granules India extended its losing streak for second straight day, down 13 percent on September 12 after US Food and Drug administration issued six observations to its Gagillapur facility in Hyderabad, Telangana following an inspection conducted from August 26 to September 6. With today's fall, the stock has crashed over 15 percent in just two days.

CNBC-TV18 reported that it has accessed Form 483 issued to Granules Gagillapur facility. The form entailed violations related to equipment and utensils not cleaned at appropriate intervals, failure to thoroughly review any unexplained discrepancy, non maintainence of building and facilities, inadequate assessment of process of material commonly performed during routine manufacturing, and failure to follow responsibilities and procedures applicable to quality control unit.

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The inspection covered both Current Good Manufacturing Practice (cGMP) and Pre-Approval Inspection (PAI) processes. The company stated that it aims to address the observations promptly and will submit its response to the USFDA within the stipulated timeframe.

Earlier in August, Granules Pharmaceuticals, Inc., a wholly-owned subsidiary of Granules India, received USFDA approval for its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Oral Solution 1mg/5mL.

Currently, around 7 brokerages cover Granules India stock - all of them recommended a 'buy' on the counter. At current market price, Granules India has been trading at 5x price-to-book (PB) ratio, lower than Glenmark Life's 6.7x PB ratio, Laurus Labs 6.6x PB ratio, and Wockhardt's 8.5x PB ratio.

So far this year, shares of Glenmark Life surged over 46 percent, beating benchmark Nifty 50's 15 percent surge. Earlier, the stock had touched 52-week high of Rs 724 per share on September 2, 2024.

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