Date: September 15, 2026
Regulatory Compliance Update
US FDA Inspection Outcome
- The United States Food and Drug Administration (US FDA) conducted an inspection at Unit-II, an API manufacturing facility of Apitoria Pharma Private Limited (wholly owned subsidiary)
- Inspection period: September 7, 2026 to September 15, 2026
- Facility location: Gaddapotharam, Industrial Development Area – Kazipally Industrial Area, Jinnaram Mandal, Sangareddy District, 502319, Telangana
- Inspection outcome: Concluded with one observation, described as procedural in nature
- Company response: Will respond to US FDA within the stipulated timeline
Company Commitment
- The Company is committed to maintaining robust quality and compliance standards across its manufacturing facilities
Regulatory Compliance
- Disclosure made pursuant to Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015
- Company will keep Stock Exchanges informed of any further developments as required under applicable regulations