Date: May 29, 2026
Regulatory Compliance Update
Jubilant Pharmova Limited announced that its jointly owned partnership, Jubilant HollisterStier General Partnership (JHSGP), has received a Warning Letter from the United States Food and Drug Administration (USFDA). This communication follows the USFDA's review of the Establishment Inspection Report for the inspection conducted at JHSGP's Kirkland, Canada facility located at 16751 Trans-Canada Highway. The inspection took place from October 20 to November 3, 2025.
The company received this communication on May 28, 2026, at 08:49 AM PST (9:19 PM IST).
Corrective Actions and Current Operations
JHSGP has been proactively engaging with the USFDA and has already initiated appropriate corrective and preventive actions. The company is committed to addressing the observations comprehensively. Current operations at JHSGP are proceeding under enhanced controls and oversight while remediation efforts are actively underway.
Ownership Structure
Jubilant HollisterStier General Partnership is jointly owned by subsidiaries of Jubilant Pharma Limited, which is a wholly owned subsidiary of Jubilant Pharmova Limited. The specific subsidiaries mentioned include Jubilant HollisterStier Inc., Draxis Pharma LLC, and 1359773 B.C. Unlimited Liability Company.
Business Context
JHSGP is a Canada-based strategic alliance that contributes to the company's global Contract Development and Manufacturing Organization (CDMO) capabilities. The facility offers contract manufacturing services for sterile products, including liquid and lyophilized injectables, ophthalmic solutions, and sterile ointments.
Disclosure Compliance
This announcement is made in accordance with Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015, and serves as a continuation of previous communications dated February 13, 2026 and November 4, 2025.