The US Food and Drug Administration (USFDA) had issued six observations to Granules India’s Gagillapur facility in Hyderabad, Telangana, following an inspection, which was conducted from August 26 to September 6.

CNBC-TV18 has accessed Form 483 issued to Granules’ Gagillapur facility.

Here are the key violations identified:

– Equipment and utensils not cleaned at appropriate intervals.

– Failure to thoroughly review any unexplained discrepancy.

– In observation no 2, USFDA points out to a repeat observation from January 2023.

– Responsibilities and procedures applicable to quality control unit not in writing, fully followed.

– Process of material commonly performed during routine manufacturing not been adequately assessed.

– Written procedures are not followed.

– Building and facilities not maintained.

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.

This product is bioequivalent and therapeutically equivalent to Merz Pharmaceuticals’ Cuvposa Oral Solution 1 mg/5 mL.

Shares of Granules India Ltd. are currently trading with losses of 9.45% at ₹612.75. Despite the correction, the stock has risen about 50% so far in 2024.