The U.S. drug regulator has flagged a quality control lapse at Glenmark Pharmaceutical Ltd.'s Aurangabad facility.
The U.S. Food and Drug Administration has issued Form 483 with one observation after an inspection at the drugmaker's formulations facility in Aurangabad between June 27 and July 1, 2022, Glenmark Pharma had then said in an exchange filing, without disclosing any details.
BQ Prime has obtained a copy of the observation by the FDA. It shows the American regulator has found failure to review unexplained discrepancy of a batch that could meet the required specifications.
When an ‘out-of-specification' result for a batch was observed and the company could not find any assignable cause in two phases of inspection, it marked the ‘OOS' result as a sample preparation error. Based on inconclusive assignable cause, new samples were retested invalidating initial ‘OOS' results.
OOS means that result of the testing falls outside the predetermined specifications or established acceptance criteria set by the manufacturer and /or the laboratory and must therefore, be investigated.
Glenmark Pharma has yet to respond to BQ Prime's emailed queries on the implications of the observations, the revenue contribution of the facility and impact on future approvals and launches. Also, the company is yet to comment on the steps being taken to address the issue and the expected timelines.
The Mumbai-based drugmaker in its July 1 filing, however, had said it would undertake all necessary steps required to address the observation at the earliest.
Glenmark Pharma will be declaring its financials for the quarter ended June on Aug 10. Its shares were trading 1.1% higher against a 0.12% fall in the benchmark Sensex as of 12:37 p.m.
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