Zydus Lifesciences gets four observations in USFDA inspection of Himachal Pradesh’s Baddi plant

Zydus Lifesciences Limited on Wednesday (August 13) said the US Food and Drug Administration (USFDA) has concluded a surveillance inspection at its formulation manufacturing plant in Baddi, Himachal Pradesh.The inspection was carried out from August 4 to August 13, 2025. The company said the inspection ended with four observations, with no data integrity-related remarks.

Zydus Lifesciences added that it will work closely with the USFDA to address the observations at the earliest.

First Quarter ResultsZydus Lifesciences reported a 3.3% growth in its net profit to ₹1,467 crore, which was also aided by a forex gain of ₹57 crore. The base quarter had a forex loss of ₹25 crore. The net profit figure was also higher than the CNBC-TV18 poll of ₹1,211.6 crore. Revenue for the quarter increased by 6% from last year to ₹6,574 crore, which is also higher than the CNBC-TV18 poll estimate of ₹6,350 crore.

Also Read: Zydus Lifesciences gets first Canadian nod for smoking deterrent varenicline tabletsEarnings Before Interest, Tax, Depreciation and Amortisation (EBITDA) for the quarter remained flat at ₹2,089 crore, while analysts were working with a number of ₹1,879.3 crore. EBITDA margins, though, narrowed by nearly 200 basis points to 31.8% from 33.6% last year. Analysts were expecting the margin figure to be at 29.6%.

US sales for the quarter remained largely flat from last year and increased 2.5% from the March quarter to $372 million.

“We remain firmly on track to achieve our FY2026 aspirations and are excited about the upcoming developments on the innovation front, which we believe will open up new avenues for sustainable growth,” Sharvil Patel, the Managing Director of Zydus Lifesciences, was quoted as saying.

Also Read: Zydus Lifesciences Ahmedabad plant clears US FDA inspection with nil observations

Shares of Zydus Lifesciences Ltd ended at ₹989.05, up by ₹32.95, or 3.45%, on the BSE.