Biocon gets 6 observations from USFDA for its Malaysian facility in pre-approval inspection

"We expect results from the phase 4 study on itolizumab by the end of this quarter. This would be real-world data from around 300 patients," said Arun Chandavarkar, Managing Director of Biocon Biologics (Representative image)

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26 Aug, 2025 12:21

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Drugmaker Biocon on September 27 said it has received six observations from USFDA for its insulin manufacturing facility in Malaysia.

The onsite inspection which was conducted between September 13 and September 24 was a pre-approval inspection (PAI) related to Insulin Aspart.

"At the conclusion of the inspection, the agency has issued a Form 483 with a total of 6 observations across Drug Substance, Drug Product and Devices Facilities," Biocon said in a statement.

"We are confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan (CAPA), which will be submitted to the US FDA in the stipulated time," Biocon spokesperson said.

"We do not expect the outcome of this inspection to impact our commercialisation plans for insulin Aspart in the US. Biocon Biologics remains committed to global standards of Quality and Compliance.” the spokesperson said.

Shares of Biocon declined 0.75 percent and were trading at Rs 357.50 on BSE at 1.35 pm on Monday. The benchmark Sensex rose 0.23 percent to 60,188.93 days