Unichem Labs Goa facility gets 5 observations from USFDA

16 Jul 2024 , 11:11 AM

Unichem Laboratories Ltd announced on Monday (July 15) that the US Food and Drug Administration (FDA) inspected its Goa formulation facility from July 8, 2024, to July 15, 2024.

“The United States Food and Drug Administration (USFDA) inspected the company’s Goa formulation facility from 8th July 2024 to 15th July 2024,” according to the company’s filing with the bourses.

The inspection finished with five observations, most of which were procedural and had nothing to do with data integrity. Unichem Labs has agreed to respond within the 15-working-day deadline.

According to the corporation, the observations have no influence on business continuity or supplies to the US market.

Unichem Laboratories was founded by the late Mr. Amrut Mody, a pioneer in the Indian pharmaceuticals market, and has grown to become one of India’s most regarded pharmaceutical enterprises. It is committed to providing improved health through quality products.

With formulations at the heart of the company’s operations, Unichem is backward integrated to API Manufacturing, adding value to the customer in terms of quality and sustainability.

Unichem Laboratories announced its Q4 results on May 22, 2024. The topline climbed by 7.36%, while the loss increased by 192.12% YoY. Compared to the previous quarter, revenue fell by 0.62%, while loss climbed by 253.96%.

At around 11.07 AM, Unichem Laboratories was trading 0.68% lower at ₹531.45, against the previous close of ₹535.10 on NSE. The counter touched an intraday high and low of ₹542.90, and ₹518.60, respectively.

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