Mumbai: The US Food and Drug Administration (FDA) has raised concerns about Glenmark Pharmaceuticals Ltd’s plant in Baddi, Himachal Pradesh, citing seven observations relating to violation of good manufacturing practices (GMP).
The US regulator had inspected the Baddi unit from 6-11 November and issued a Form 483, reviewed by Mint, to the company.
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.
Shares of Glenmark closed 3.3% down at Rs571.80 on BSE, while benchmark Sensex index ended at 33,618.59 points, down 0.3% from Monday’s close.
In a stock exchange filing on Tuesday, Glenmark said, “We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA shortly.”
The observations made by US FDA for the Baddi unit are: No thorough review of unexplained discrepancy in drug batches; lack of written procedures to assure identity and strength of products; deficient complaint records; inadequate maintenance of records to evaluate quality standards of each drug; insufficient adherence to responsibilities and procedures of the quality control unit; inappropriate controls over computers or related systems; and lack of proper training to employees for the functions they need to perform.
The Baddi plant accounts for 10% of Glenmark’s US sales, the company said.
In FY17, revenue rose 20% on-year to Rs9,185.68 crore. US sales stood at Rs3,700.66 crore. The last US FDA inspection of the Baddi unit happened in March 2017 when it got no observations, Edelweiss Securities said in a note.
“There is no data integration or repeat observation case here. We believe chances of escalation (to a warning letter) are low here even though first observation is very similar to Lupin’s Goa and Indore plant observation. In Lupin’s case it was a repeat observation at multiple locations,” Edelweiss said in the note.
Earlier this month, Lupin Ltd’s Goa and Indore manufacturing facilities received a warning letter from the US FDA, in which the regulator highlighted that the firm repeatedly ignored tests showing that drugs made at these two units did not meet quality standards and that the company failed to thoroughly investigate batch failures.
Wed, Nov 29 2017