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Dr Reddy's: US FDA issues form 483 with 4 observations for its Andhra facility

Post the observations, Dr Reddy's said that it will address the issues within the stipulated timeline.

June 07, 2024 / 19:41 IST
The observations were issued after the drug regulatory body conducted a GMP inspection from May 30 to June 7.

The observations were issued after the drug regulatory body conducted a GMP inspection from May 30 to June 7.

 
 
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Pharma major Dr Reddy's Laboratories said that the US Food & Drug Administration (USFDA) on June 7 issued a Form 483 with four observations at the API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh.

The observations were issued after the drug regulatory body conducted a GMP inspection from May 30 to June 7.

Post the observations, Dr Reddy's said that it will address the issues within the stipulated timeline.

Shares of Dr Reddy's on June 7 closed 2.38 percent higher at Rs 6,037.55 apiece on BSE.

Last month, US FDA had issued Form 483 with two observations after the inspection conducted at its formulations manufacturing facilities (FTO-7 & FTO-9) in Duvvada, Visakhapatnam, Andhra Pradesh.

Dr. Reddy's Laboratories is engaged in providing medicines. The firm operates in three segments: global generics, pharmaceutical services and active ingredients (PSAI) and proprietary products.

The drug major's consolidated net profit increased 36.26% to Rs 1,307 crore on 12.49% rise in revenues to Rs 7,083 crore in Q4 FY24 over Q4 FY23.

The counter shed 0.71% to end at Rs 5,799.25 on Friday, 17 May 2024.

Moneycontrol News
first published: Jun 7, 2024 07:41 pm

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