Pharmaceutical major Aurobindo Pharma’s subsidiary, APL Healthcare Limited has received a ‘Form 483’ with one observation from the US Food and Drug Administration for its Unit IV plant in Tirupati District, Andhra Pradesh, the company informed stock exchanges on September 20
The inspection was conducted from September 13-19, 2023.
The company said in the press statement that the ‘Form 483’ which was issued with 1 observation is procedural in nature. The US FDA issues a Form 483 when it observes any lapses during its inspection of a facility. The companies are then guided to implement corrective action plans to rectify the issues.
A procedural observation is the lowest concern for companies according to analysts. Quality or data integrity issues are of higher concern and can lead to serious action from the regulator.
Aurobindo Pharma said that it will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observation at the earliest.
Analysts expect EBITDA margins of the company to be in the range of 18-20 percent for the current fiscal due to changes in product mix and fall in raw material costs in earlier reports. They also predict a strong growth in Aurobindo’s US business driven by the launch of g-Revlimid in October 2023.
Aurobindo Pharma on August 12 reported a 22.5 percent decline in consolidated net profit at Rs 540.40 crore in the April-June quarter. Shares of the company were trading at Rs 892.70, down 0.23 percent on NSE at 11.12 am on September 20.
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