Gandhar Oil Refinery India receives EIR from USFDA classifying VAI

Gandhar Oil Refinery (India) Limited has received the Establishment Inspection Report (EIR). The USFDA has classified the inspection as Voluntary Action Indicated (VAI) and concluded the inspection is closed. The above is pursuant to the inspection conducted by the Unites States Food & Drug Administration (USFDA) at its company's manufacturing facility located at Taloja.

FDC receives final approval from USFDA for ANDA Cefixime 400 mg Tablets

FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets.

USFDA completes inspection at Unit V of Apitoria Pharma

The United States Food and Drug Administration (US FDA) inspected Unit-V, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of the Company, situated at Pashamylaram Village, Patancheru Mandal, Sanga Reddy District, Telangana from December 09 to December 17, 2024. The inspection closed with 2 observations. The observations are of procedural in nature and will be responded to within the stipulated time.