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Gagillapur
Jeedimetla
Bonthapally
Wuhan
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
8000 MTPA Capacity (+ 2,000 starting in November 2009)
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)
Infarmed (EU), TGA
API - Ibuprofen
Wuhan, China
4800 MTPA
U.S. FDA, EDQM, TGA, Russian Authority, and MCC Regulatory Authorities