Date: June 3, 2026
Regulatory Compliance Disclosure
The Company has received a Warning Letter from the United States Food and Drug Administration (USFDA) relating to its formulation manufacturing facility located at Baddi, Himachal Pradesh.
Nature of Warning Letter
- The Warning Letter was issued in response to a request for records pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act
- The communication does not pertain to any onsite inspection of the facility by the USFDA
- The warning references technical observations regarding the use of purified talc that did not meet the current United States Pharmacopeia (USP) requirements
Facility Inspection History
- The Baddi manufacturing facility was last subjected to an on-site inspection by the USFDA in August 2025
- The Company received the Establishment Inspection Report (EIR) in October 2025
- The final compliance status was classified as Voluntary Action Indicated (VAI)
Company Response and Impact Assessment
- The Company believes the Warning Letter will not impact current operations and supplies from the Baddi site
- The Company is committed to working collaboratively and transparently with the USFDA
- The Company plans to complete necessary remediation steps at the earliest
- The Company will respond within the stipulated timelines