Facility

Intas Pharmaceuticals Ahmedabad API Manufacturing Complex

Intas Pharmaceuticals' primary API manufacturing complex in Ahmedabad, Gujarat (including the Sanand industrial estate satellite facility, ~30 km southwest of Ahmedabad city center). FDA FEI 3003889748. This facility was the world's single largest cisplatin API production site, supplying an estimated 50-60% of US cisplatin requirements. FDA investigators visited in November 2022 and discovered hundreds of trash bags of shredded quality-control documentation — evidence of systematic data integrity violations. FDA issued 10 observations in the Form 483 and a Warning Letter in December 2022. Intas voluntarily suspended API production. The shutdown triggered the US cisplatin shortage that began February 2023 and the carboplatin shortage that began April 2023. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/intas-pharmaceuticals-limited-667094-12222022