Moneycontrol PRO
UPCOMING EVENT:Attend Traders Carnival Live. 3 days 12 sessions at Rs.1599/-, exclusive for Moneycontrol Pro subscribers. Register now!

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

"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.

September 27, 2021 / 02:20 PM IST

"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)

 
 
live
  • bselive
  • nselive
Volume
Todays L/H
More

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.

Close
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
Viswanath Pilla is a business journalist with 14 years of reporting experience. Based in Mumbai, Pilla covers pharma, healthcare and infrastructure sectors for Moneycontrol.
first published: Sep 27, 2021 02:19 pm

stay updated

Get Daily News on your Browser
Sections
ISO 27001 - BSI Assurance Mark