Shilpa Medicare Telangana facility gets EIR from USFDA
"The USFDA has concluded that the inspection classification of Jadcherla facility was "voluntary action indicated". This facility is in an acceptable state of compliance with regard to current good manufacturing practices," Shilpa Medicare said in a filing.
New Delhi: Drug firm Shilpa Medicare recently said it has received the US Food and Drug Administration (USFDA) 'Establishment Inspection Report' for the Finished Dosage Formulation Facility (Sterile and Non-sterile Dosage Forms) at S-20 to S-26, Pharmaceutical Formulations SEZ, APIIC, Jadcherla, Telangana.
Also Read: Shilpa Medicare gets 2 USFDA observations for Telangana facility
Shilpa Medicare's finished dosage form facility was inspected by the US FDA from 29th August to 6th September 2019.
"The USFDA has concluded that the inspection classification of this facility was "voluntary action indicated". This facility is in an acceptable state of compliance with regard to current good manufacturing practices," Shilpa Medicare said in a filing.
Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989.
Also Read: Shilpa Medicare gets 5 USFDA observations for Raichur facility
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