APL Healthcare’s Unit-4 gets 5 observations from USFDA

The United States Food and Drug Administration (US FDA) inspected Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of the Company, situated at Palchur village and part of Palepalem Village Naidupeta Mandal, SPSR Nellore District, 524126, Andhra Pradesh, from December 08 to December 17, 2025. At the end of the current inspection, a 'Form 483' was issued with 05 observations which are procedural in nature, and we will respond to the US FDA within the stipulated timelines.

Biocon receives EIR from USFDA with VAI status for Cranbury facility

Biocon Ltd has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (US FDA), for Biocon Generics Inc facility, located in Cranbury, New Jersey, U.S. This is based on a cGMP inspection conducted by the agency between the 6th to 10th of October, 2025.

USFDA determines Sun Pharma's Baska facility inspection classification as OAI

The US FDA conducted an inspection at Sun Pharmaceutical Industries Ltd's Baska facility from 8 September 2025 to 19 September 2025. The US FDA has subsequently determined that the inspection classification status of this facility is Official Action Indicated (OAI). The company continues to manufacture and supply approved products from the facility to the US market. The company will work with the regulator to achieve fully compliant status.

Clean Fino-Chem commences commercial production of HQ and Catechol

Clean Fino-Chem Limited (CFCL) has commenced commercial production of Hydroquinone (HQ) and Catechol in a dedicated production block. The Company would be key domestic manufacturer of Hydroquinone and Catechol, leading to import substitution led demand traction. With commercialization of Hydroquinone, value proposition of performance segment strengthens further by creating cross-selling opportunity with MEHQ customers. Catechol will also be captively consumed for production of Guaiacol and Veratrole.