FDC secures USFDA approval for pilocarpine hydrochloride ophthalmic solution

FDC Limited announced on October 4, 2025, that it has received Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (U.S.FDA). This approval is for Pilocarpine Hydrochloride Ophthalmic Solution USP, in 1%, 2%, and 4% (15 mL) concentrations.

The intimation was made under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. This development marks a key achievement for FDC Limited in expanding its product offerings in the global pharmaceutical market.