Laurus Labs US arm gets 1 USFDA observation

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-01-23 08:45 GMT | Update On 2025-01-23 08:45 GMT

Andhra Pradesh: Laurus Labs has announced that Laurus Generics Inc., a wholly-owned foreign subsidiary of the company, located in Berkeley Heights, New Jersey, USA has received one observation from the US Food and Drug Administration (USFDA) after a Post-marketing Adverse Drug Experience (PADE) inspection.

The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Laurus Labs marketed products worldwide.

The inspection was conducted for four days between 13th January, 2025 to 21st January, 2025.

"We have been issued a Form 483 with one observation and the Company will address the said observation within stipulated timelines," the company stated in a BSE filing.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Laurus Labs is an Indian pharmaceutical company headquartered in Hyderabad. The Company's major focus areas include anti-retroviral, Hepatitis C, and Oncology drugs.

Most of the Laurus Labs manufacturing facilities are approved by major regulatory authorities USFDA, WHO-Geneva, UK-MHRA, etc.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Laurus Labs US arm gets 1 USFDA observation

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