Laurus Labs gets USFDA EIR for Atchutapuram facility
Andhra Pradesh: Laurus Labs has announced that the company has received the Establishment Inspection Report (EIR) from the United States Food & Drug Administration (USFDA) for its API manufacturing facility Unit–4, Atchutapuram, Anakapalli District (Visakhapatnam), Andhra Pradesh.
The inspection of the facility was conducted by the USFDA from January 27 to January 31, 2025. Following the inspection, the company had initially received a Form 483 with one observation.
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.
"Further to our intimation dated 31st January, 2025, on the inspection conducted by the United States Food & Drug Administration (USFDA) at our API manufacturing facility Unit–4, Atchutapuram, Anakapalli District (Visakhapatnam), Andhra Pradesh from 27th January, 2025 to 31st January, 2025, we are pleased to inform you that the Company has received the Establishment Inspection Report (EIR)," the Company stated in a BSE filing.
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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