The inspection was conducted from September 22 to September 25, 2026, the company said in an exchange filing.
Zydus said the inspection covered its pharmacovigilance and post-marketing surveillance system and was conducted onsite at its US office.
The company disclosed the development under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
Zydus Lifesciences shares are listed on the BSE and National Stock Exchange of India.
Earlier in August, Zydus Lifesciences had received final USFDA approval for its generic version of Ascorbic Acid Injection, a product with annual US sales of around $11.6 million.
The approval covered Ascorbic Acid Injection USP in two strengths — 25,000 mg/50 mL and 5,000 mg/10 mL — both at a concentration of 500 mg/mL.
The US regulator had designated Zydus’ abbreviated new drug application (ANDA) for the product as a Competitive Generic Therapy (CGT), making it eligible for potential 180-day exclusivity, according to the company.
The injection is used for the short-term treatment of scurvy in adults and children aged five months and older when oral administration is not possible, insufficient or contraindicated.
Zydus said the product would be manufactured at its USFDA-approved injectable facility in Jarod, near Vadodara, Gujarat, and marketed in the US through Zydus Pharmaceuticals (USA) Inc.
The company said its product is the generic equivalent of Ascor, the reference listed drug. Eligibility for the 180-day exclusivity is determined by the USFDA and, where applicable, the period begins on the first day of commercial marketing.