Zydus Lifesciences gets EIR from USFDA for Ahmedabad facility; shares trade lower

Zydus Lifesciences

Zydus Lifesciences share price down marginally in the opening trade on November 6 following the company received zero observation from USFDA.

At 09:22 hrs Zydus Lifesciences was quoting at Rs 971.00, down Rs 1.85, or 0.19 percent, on the BSE.

The United States Food and Drug Administration (USFDA) has conducted an inspection at the group’s manufacturing plant located SEZ – II, Ahmedabad, between August 11-14, 2025.

The inspection was a pre-approval inspection (PAI) and concluded with NIL observations.

The Establishment Inspection Report (EIR) has classified the facility as No Action Indicated (NAI).

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On November 4, the company received tentative approval from the USFDA for Budesonide delayed-release capsules, 4 mg, which is indicated for mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in adults and children 8 years of age and older.

Budesonide capsules will be produced at is Zydus Pharmaceuticals Ltd, SEZ-II.

In October, the company received the Establishment Inspection Report (EIR) from the USFDA for an inspection conducted at its manufacturing facility located at Baddi, from August 4-13, 2025.

In the previous trading session, the share closed at Rs 972.85, down Rs 7.90, or 0.81 percent.

The share touched a 52-week high of Rs 1,059.00 and a 52-week low of Rs 797.05 on 19 September, 2025 and 07 April, 2025, respectively.

Currently, the stock is trading 8.31 percent below its 52-week high and 21.82 percent above its 52-week low.

The market capitalisation of the company stands at Rs 97,705.32 crore.