Dr Reddy's Laboratories Ltd on Tuesday said the US health regulator has issued a Form 483 with seven observations to its active pharmaceutical ingredient manufacturing facility in Bollaram, Hyderabad. "The US Food & Drug Administration (USFDA) today completed a GMP inspection at our API manufacturing facility (CTO-2) in Bollaram, Hyderabad," Dr Reddy's Laboratories Ltd (DRL) said in a regulatory filing. The inspection was conducted from November 13-19, 2024, it added. "We have been issued a Form 483 with seven observations, which we will address within the stipulated timeline," the company said. As per US Food and Drug Administration (USFDA), Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

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Dr Reddy's Hyderabad API Plant Gets Seven Observations From USFDA

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Dr. Reddy's Laboratories Ltd.

19 Nov 2024

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Company Update

DR.REDDY'S LABORATORIES LTD. - 500124 - Announcement Under Regulation 30 Of SEBI (LODR) Regulations, 2015

BSE India

Announcement under Regulation 30 of SEBI (LODR) Regulations, 2015

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Dr. Reddy's Laboratories Ltd.

19 Nov 2024

1182.90

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Company Update

DR.REDDY'S LABORATORIES LTD. - 500124 - Announcement under Regulation 30 (LODR)-Credit Rating

BSE India

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Dr. Reddy's Laboratories Ltd.

18 Nov 2024

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Dr. Reddy's Laboratories Clarifies Recall Of Morphine Sulfate Tablet In US

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Dr. Reddy's Laboratories recalled two lots of Morphine Sulfate extended-release tablets in the US.

Dr. Reddy's Laboratories Ltd. is trading above its 50 day SMA of 1155.2

Dr. Reddy's Laboratories Ltd.

18 Nov 2024

1182.90

-0.08%

Company Update

DR.REDDY'S LABORATORIES LTD. - 500124 - Clarification On Reported News Article

BSE India

Clarification on reported news article

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Dr. Reddy's Laboratories Ltd.

18 Nov 2024

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Company Update

DR.REDDY'S LABORATORIES LTD. - 500124 - Clarification sought from Dr Reddys Laboratories Ltd

BSE India

The Exchange has sought clarification from Dr Reddys Laboratories Ltd on November 18, 2024, with reference to news appeared in https://economictimes.indiatimes.com dated November 18, 2024 quoting "Dr Reddy''s, FDC recall products in US for manufacturing issues" The reply is awaited.