Granules India Limited - Regulatory Approvals

Regulatory Approvals

Continuously filing DMFs and ANDAs in respective regulated and semi-regulated markets.
Type of Facility Location Capacity Approval from
API - Paracetamol/Acetaminophen Bonthapally 10000 MTPA Capacity U.S.FDA, WHO GMP, EU, and COS Regulatory Authorities
API Jeedimetla
  • Metformin – 960 MTPA
  • Guaifenesin – 780 MTPA
  • Methocarbamol – 96 MTPA
  • Phenazopyridine – 50 MTPA
U.S. FDA, KFDA, TGA, and EDQM Regulatory Authorities
PFI - Multiple Small Volume Facility Jeedimetla 1800 MTPA U.S. FDA, KFDA, TGA, and EDQM Regulatory Authorities
PFI Gagillapur 7200 MTPA EU , GHCA , and TGA Regulatory Authorities
Formulation Gagillapur 6 billion tablets per annum (Scalable to 12 billion tablets per annum) U.S. FDA, Infarmed and TGA
API - Ibuprofen Wuhan, China 4800 MTPA U.S. FDA, EDQM, TGA, Russian Authority, KFDA and MCC Regulatory Authorities