Shares of Granules India Ltd. fell 8% after reaching a day’s high of Rs 690 on 12th September, following six USFDA observations issued to the company’s Gagillapur facility in Hyderabad. The inspection occurred from 26th August to 6th September.
Some of the key violations are mentioned as follows:
- Equipment and utensils were not cleaned at appropriate intervals.
- Unexplained discrepancies were not thoroughly reviewed.
- One observation was a repeat from January 2023.
- Quality control unit responsibilities and procedures were not documented or fully followed.
- The material processing routine was not adequately assessed.
- Written procedures were not followed.
- Buildings and facilities were not properly maintained.
In August, Granules Pharmaceuticals, Inc., a subsidiary of Granules India, received USFDA approval for its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Oral Solution 1 mg/5 mL.
This product is bioequivalent and therapeutically equivalent to Merz Pharmaceuticals’ Cuvposa Oral Solution 1 mg/5 mL.
So far, in 2024, the stock has surged almost 48%. The company’s market capitalisation fell to Rs 16,428 crore.
At 12:37 PM, the shares of Granules India were trading 10.82% lower at Rs 603.50 on NSE.
Ready to invest like a pro? Unicorn Signals app equips you with 100+ Free tools and knowledge you need to succeed. Download the Unicorn Signals app and gain access to daily stock lists and insightful market analysis and much more!
